Osteo Arthritis Knee and HipPhase 4GASPSNCT07334132
General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty
A Phase 4 study testing General Anaesthesia and Spinal Anesthesia (bupivacaine) in people with Osteo Arthritis Knee and Hip and Osteo Arthritis, run by Region Örebro County.
Trial summary
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteo Arthritis Knee and Hip, Osteo Arthritis, Inflammatory Joint Disease (IJD)
- What is being tested?
- General Anaesthesia and Spinal Anesthesia (bupivacaine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has given their written consent to participate in the trial.
- Planned for primary TKA or THA.
- Adults aged 18 to 80 years at time of written consent.
- ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
- Scheduled start of surgery before 13:00.
- Ability to communicate in Swedish, ensuring understanding of informed consent and follow-up procedures.
Who cannot join
- Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
- Body mass index (BMI) > 35 kg/m.
- Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
- Haemoglobin < 120 g/L (sample no older than 3 months).
- Known bleeding disorders, including coagulopathies.
- Known allergies to investigational anaesthetic drugs (e.g., bupivacaine, remifentanil, or propofol).
Show all 12Show fewer
- Neurological conditions with persistent motor or sensory deficits.
- Localised infections at the spinal injection site.
- Determined by the surgical or anaesthesia team to be unsuitable for trial participation and/or outpatient surgery.
- Women of childbearing potential (i.e., those who are fertile, following menarche and until becoming post-menopausal, unless permanently sterile)
- Who are not willing to use a highly effective method of contraception judged by the investigator, from the time of signing the informed consent, OR
- Who has a positive pregnancy test at enrolment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. This can be beneficial for both patients and healthcare systems, but it requires safe and efficient anaesthetic care.
Two different types of anaesthesia are commonly used for these operations: general anaesthesia (where the patient is asleep) and spinal anaesthesia (where the lower part of the body is numbed). Both methods are well established and widely used. Previous studies suggest that the choice of anaesthesia may affect how quickly patients recover, how comfortable they feel after surgery, and whether they can be safely discharged on the day of surgery. However, most existing studies are based on retrospective data, and there is limited randomized evidence comparing these anaesthetic techniques in the outpatient setting.
Read more
The GASPS trial is a multicentre, randomized, phase IV clinical study that compares general anaesthesia and spinal anaesthesia in adults undergoing outpatient primary total knee or hip arthroplasty. A total of 600 participants will be included and randomly assigned to receive one of the two anaesthetic methods on the day of surgery. All participants will receive standard surgical and perioperative care, and both anaesthetic techniques are part of routine clinical practice.
The main aim of the study is to investigate whether the type of anaesthesia influences the chance of successful same-day discharge, defined as going home on the day of surgery without needing to be readmitted within 48 hours. The study will also examine recovery time, pain, nausea and vomiting, use of pain medication, complications, patient-reported recovery and function, and healthcare costs. In addition, patient experiences of anaesthesia and postoperative recovery will be explored through interviews in a smaller group of participants.
Participants will be followed using questionnaires and medical records from the day of surgery up to 12 months after the operation. The results of this study are expected to provide clear and reliable information to help guide anaesthetic care for patients undergoing outpatient hip and knee replacement surgery.
Read the detailed description
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are among the most frequently performed elective surgical procedures and are highly effective treatments for advanced joint disease, most commonly osteoarthritis. Over the past decade, improvements in surgical techniques, perioperative care pathways, anaesthetic management, and postoperative rehabilitation have enabled an increasing proportion of these procedures to be performed as outpatient surgery, allowing patients to return home on the day of surgery. Outpatient arthroplasty has the potential to improve patient satisfaction, reduce hospital length of stay, lower healthcare costs, and decrease the risk of hospital-acquired complications. However, achieving safe and successful same-day discharge requires carefully optimized perioperative care.
Anaesthetic management is a central component of outpatient arthroplasty pathways. Both general anaesthesia (GA) and spinal anaesthesia (SA) are routinely used for TKA and THA, and both techniques are well established with extensive safety data. Neuraxial anaesthesia has traditionally been associated with reduced intraoperative blood loss and certain postoperative complications, and it is commonly recommended in clinical guidelines for hip and knee arthroplasty. In contrast, modern general anaesthesia using short-acting intravenous agents may offer advantages in the outpatient setting, including predictable onset and offset, rapid recovery of motor function, and reduced postoperative nausea and vomiting when volatile agents are avoided.
Despite widespread clinical use of both techniques, the optimal choice of anaesthesia for outpatient TKA and THA remains uncertain. Much of the existing evidence comparing GA and SA is derived from retrospective observational studies and registry-based analyses. These studies often include mixed inpatient and outpatient populations and are subject to confounding by indication, as patients receiving GA frequently differ from those receiving SA with respect to comorbidity, functional status, or anticipated surgical complexity. As a result, it is difficult to determine whether observed differences in outcomes are attributable to the anaesthetic technique itself or to underlying patient characteristics. Randomized clinical trials specifically designed to compare GA and SA in the outpatient arthroplasty setting are scarce.
The GASPS (General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty) trial was designed to address this evidence gap. GASPS is a multicentre, randomized, phase IV clinical trial comparing GA and SA in adults undergoing outpatient primary TKA or THA. The overarching aim of the trial is to generate high-quality randomized evidence on whether the choice of anaesthetic technique influences the likelihood of successful same-day discharge and postoperative recovery in outpatient arthroplasty.
A total of 600 participants will be enrolled across multiple orthopaedic centres in Sweden. Eligible patients scheduled for outpatient primary TKA or THA are randomized on the day of surgery to receive either GA or SA. Randomization is performed using a stratified permuted block design, with stratification by type of surgery (knee or hip arthroplasty) and study site, to ensure balanced allocation across groups. Allocation concealment is maintained until shortly before surgery. Due to the nature of the interventions, blinding of patients and clinical staff is not feasible; however, data analysts remain blinded during analysis.
Both anaesthetic techniques are delivered according to standardized protocols that reflect contemporary routine clinical practice. General anaesthesia is provided using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, administered by trained anaesthesiologists. Spinal anaesthesia is administered as a single-shot intrathecal block with bupivacaine, with optional intrathecal opioid adjuncts and light sedation as clinically indicated. No experimental drugs or procedures are introduced, and all perioperative care apart from the assigned anaesthetic technique follows local standard practice.
The primary outcome of the trial is successful same-day discharge, defined as discharge from hospital on the day of surgery without readmission within 48 hours. This outcome was chosen as a clinically meaningful and patient-relevant measure of perioperative success in outpatient arthroplasty, integrating both recovery efficiency and short-term safety. Successful same-day discharge reflects the combined effects of anaesthetic technique, surgical care, postoperative recovery, and early complication rates.
Secondary outcomes are designed to capture multiple dimensions of perioperative and postoperative recovery. These include perioperative time metrics related to anaesthesia induction, surgery, and recovery; early postoperative outcomes such as pain, nausea and vomiting, opioid consumption, mobilisation, and adverse events; and patient-reported outcomes assessing quality of recovery, function, and health-related quality of life. Recovery is conceptualized as a multi-phase process, ranging from early recovery in the postoperative care unit to longer-term recovery at home. Validated instruments such as the Quality of Recovery-15 (QoR-15), Knee injury and Osteoarthritis Outcome Score (KOOS), Hip disability and Osteoarthritis Outcome Score (HOOS), and EQ-5D-5L are used to assess these domains over time.
In addition to quantitative outcomes, the GASPS trial incorporates a qualitative component to explore patient experiences of anaesthesia and postoperative recovery. Semi-structured interviews are conducted with a subset of participants several weeks after surgery. This mixed-methods approach allows for a deeper understanding of patient perceptions, expectations, and experiences that may not be fully captured by standardized questionnaires, and provides important contextual information to complement clinical and patient-reported outcome data.
Participants are followed from the day of surgery up to 12 months postoperatively using a combination of medical record review and patient-completed questionnaires. Safety monitoring focuses on adverse events occurring in the immediate perioperative period, while longer-term follow-up captures functional outcomes, quality of life, healthcare utilization, and productivity losses. A health economic evaluation is embedded within the trial to compare GA and SA in terms of costs and quality-adjusted life years, with the aim of informing resource-efficient anaesthetic strategies for outpatient arthroplasty.
By integrating randomized clinical data, patient-reported outcomes, qualitative insights, and health economic analyses, the GASPS trial aims to provide a evaluation of the role of anaesthetic technique in outpatient total knee and hip arthroplasty.
- Being tested
- General Anaesthesia, Spinal Anesthesia (bupivacaine)
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Outpatient Surgery, Same-Day Discharge, Ambulatory Arthroplasty, General Anaesthesia, Spinal Anaesthesia, Neuraxial Anaesthesia, Total Intravenous Anaesthesia, Postoperative Recovery, Quality of Recovery, QoR-15, Postoperative Pain, Postoperative Nausea and Vomiting, PONV, Patient-Reported Outcomes, Health Economic Evaluation, Cost-Effectiveness, Randomized Clinical Trial
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnaesthesiaDrug
Also called Total Intravenous Anaesthesia, TIVA, Propofol-Remifentanil Anaesthesia
General anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil. Anaesthesia is delivered intravenously using target-controlled or rate-controlled infusion systems according to routine clinical practice. Airway management and adjunct medications are provided as clinically indicated. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.
Spinal Anesthesia (bupivacaine)Drug
Also called Neuraxial Anaesthesia, Spinal Block, Intrathecal Anaesthesia
Spinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine prior to surgery. Optional intrathecal opioid adjuncts, with fentanyl or sufentanil, may be used to enhance analgesia according to routine clinical practice. Light intravenous sedation may be provided if needed for patient comfort. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site.
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia (GA) | Experimental | Participants randomized to this arm will receive general anaesthesia during outpatient primary total knee or total hip arthroplasty. General anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, delivered intravenously according to routine clinical practice. Perioperative care apart from the assigned anaesthetic technique follows standard clinical protocols at each study site. Receives: Drug: General Anaesthesia |
| Spinal Anaesthesia (SA) | Experimental | Participants randomized to this arm will receive spinal anaesthesia during outpatient primary total knee or total hip arthroplasty. Spinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine. Optional intrathecal opioid adjuncts and light intravenous sedation may be used at the discretion of the anaesthesiologist to ensure patient comfort. All other perioperative care follows standard clinical practice at each study site. Receives: Drug: Spinal Anesthesia (bupivacaine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Same-Day Discharge
Successful same-day discharge is defined as discharge from the hospital on the day of surgery without readmission within 48 hours after discharge. Discharge readiness is assessed by the treating clinical team according to routine clinical criteria. Readmissions are identified through medical record review and patient follow-up.
Measured: Day of surgery to 48 hours after discharge
Secondary outcomes (14)
Time From Start of Anaesthesia to Start of Surgery
Elapsed time from initiation of anaesthesia to the start of surgical incision, recorded intraoperatively.
Measured: Day of surgery
Time to Discharge From Post-Anaesthesia Care Unit (PACU)
Time from the start of surgery to discharge from the postoperative recovery unit (Phase II), based on predefined discharge criteria.
Measured: From intervention to time of discharge from PACU
Time to Fulfilment of Hospital Discharge Criteria
Time from the start of surgery to fulfilment of predefined criteria for discharge from hospital (Phase III), assessed by the clinical care team.
Measured: During the hospital stay for surgery.
Time to First Successful Mobilisation
Time from the start of surgery to first successful mobilisation, defined as the ability to walk with tolerable pain, and to ascend or descend stairs if applicable.
Measured: During the hospital stay for surgery.
Opioid Consumption
Postoperative opioid use converted to oral morphine equivalents (OME), recorded during hospital stay and reported by patients after discharge.
Measured: Day of surgery to postoperative day 35
Quality of Recovery (QoR-15)
Patient-reported quality of postoperative recovery measured using the Quality of Recovery-15 (QoR-15) questionnaire.
Measured: Postoperative day 1 to postoperative day 35
Postoperative Pain
Postoperative pain assessed using the Numeric Rating Scale (NRS) during hospital stay for surgery.
Measured: Day of surgery to postoperative day 35
Pain during recovery
Pain, measured with items 11 and 12 of QoR-15 questionnarie
Measured: Baseline and, postoperative day 1 to postoperative day 35
Functional Outcome After Surgery
Patient-reported functional outcomes assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS) for knee arthroplasty and the Hip disability and Osteoarthritis Outcome Score (HOOS) for hip arthroplasty.
Measured: Baseline, 4 weeks, 6 months, and 12 months postoperatively
Adverse Events and Serious Adverse Events
Incidence, severity, and frequency of adverse events and serious adverse events related to the perioperative period.
Measured: Start of anaesthesia to postoperative day 3
Predefined adverse outcomes
Incidence and frequency of predefined adverse outcomes.
Measured: Day of surgery to 35 days postoperativly
Blood transfusions
Units of blood transfusesd
Measured: During the hospital stay for surgery.
Patient Experiences of Anaesthesia and Recovery
Patient-reported experiences of anaesthesia and postoperative recovery explored through semi-structured qualitative interviews.
Measured: 14 to 60 days after surgery
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)
Incremental cost-effectiveness ratios (ICERs) comparing general anaesthesia and spinal anaesthesia, calculated as differences in total costs divided by differences in quality-adjusted life years (QALYs) gained. QALYs are derived from EQ-5D-5L measurements.
Measured: Baseline to 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis Knee and HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Region Skane
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334132
- Sponsor's protocol ID
- GASPS
- Other IDs
- 2024-520127-89-00
- Acronym
- GASPS
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.
PubMed 39425955Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. januari 2006;3(2):77-101.
Gibon E, Parvataneni HK, Prieto HA, Photos LL, Stone WZ, Gray CF. Outpatient total knee arthroplasty: is it economically feasible in the hospital setting? Arthroplast Today. 2020 Mar 13;6(2):231-235. doi: 10.1016/j.artd.2020.02.004. eCollection 2020 Jun.
PubMed 32577469Huang A, Ryu JJ, Dervin G. Cost savings of outpatient versus standard inpatient total knee arthroplasty. Can J Surg. 2017 Feb;60(1):57-62. doi: 10.1503/cjs.002516.
PubMed 28234591Churchill L, Pollock M, Lebedeva Y, Pasic N, Bryant D, Howard J, Lanting B, Laliberte Rudman D. Optimizing outpatient total hip arthroplasty: perspectives of key stakeholders. Can J Surg. 2018 Dec 1;61(6):370-376. doi: 10.1503/cjs.016117.
PubMed 30265638Kelly MP, Calkins TE, Culvern C, Kogan M, Della Valle CJ. Inpatient Versus Outpatient Hip and Knee Arthroplasty: Which Has Higher Patient Satisfaction? J Arthroplasty. 2018 Nov;33(11):3402-3406. doi: 10.1016/j.arth.2018.07.025. Epub 2018 Aug 1.
PubMed 30143333Gauthier-Kwan OY, Dobransky JS, Dervin GF. Quality of Recovery, Postdischarge Hospital Utilization, and 2-Year Functional Outcomes After an Outpatient Total Knee Arthroplasty Program. J Arthroplasty. 2018 Jul;33(7):2159-2164.e1. doi: 10.1016/j.arth.2018.01.058. Epub 2018 Feb 5.
PubMed 29506929Greimel F, Maderbacher G, Zeman F, Grifka J, Meissner W, Benditz A. No Clinical Difference Comparing General, Regional, and Combination Anesthesia in Hip Arthroplasty: A Multicenter Cohort-Study Regarding Perioperative Pain Management and Patient Satisfaction. J Arthroplasty. 2017 Nov;32(11):3429-3433. doi: 10.1016/j.arth.2017.05.038. Epub 2017 May 26.
PubMed 28641966Nilsson U, Jaensson M, Dahlberg K, Hugelius K. Postoperative Recovery After General and Regional Anesthesia in Patients Undergoing Day Surgery: A Mixed Methods Study. J Perianesth Nurs. 2019 Jun;34(3):517-528. doi: 10.1016/j.jopan.2018.08.003. Epub 2018 Nov 20.
PubMed 30470465Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
PubMed 19130163Nilsson U, Gruen R, Myles PS. Postoperative recovery: the importance of the team. Anaesthesia. 2020 Jan;75 Suppl 1:e158-e164. doi: 10.1111/anae.14869.
PubMed 31903575Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.
PubMed 17284272Calkins TE, Johnson EP, Eason RR, Mihalko WM, Ford MC. Spinal Versus General Anesthesia for Outpatient Total Hip and Knee Arthroplasty in the Ambulatory Surgery Center: A Matched-Cohort Study. J Arthroplasty. 2024 Jun;39(6):1463-1467. doi: 10.1016/j.arth.2023.12.020. Epub 2023 Dec 15.
PubMed 38103803Keulen MHF, Asselberghs S, Boonen B, Hendrickx RPM, van Haaren EH, Schotanus MGM. Predictors of (Un)successful Same-Day Discharge in Selected Patients Following Outpatient Hip and Knee Arthroplasty. J Arthroplasty. 2020 Aug;35(8):1986-1992. doi: 10.1016/j.arth.2020.03.034. Epub 2020 Mar 27.
PubMed 32307291Gazendam AM, Tushinski D, Patel M, Bali K, Petruccelli D, Winemaker M, DeBeer J, Gillies L, Best K, Fife J, Wood TJ. Causes and predictors of failed same-day home discharge following primary hip and knee total joint arthroplasty: a Canadian perspective. Hip Int. 2023 Jul;33(4):576-582. doi: 10.1177/11207000221111101. Epub 2022 Jul 17.
PubMed 35848135
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07334132
- Acronym / sponsor ID
- GASPS / GASPS
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Outpatient Surgery, Same-Day Discharge, Ambulatory Arthroplasty, General Anaesthesia, Spinal Anaesthesia, Neuraxial Anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Region Skane
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are common operations used to treat severe joint disease, most often caused by osteoarthritis. An increasing number of these procedures are now performed as outpatient surgery, meaning that patients can go home on the same day as the operation. This can be beneficial for both patients and healthcare systems, but it requires safe and efficient anaesthetic care.
Two different types of anaesthesia are commonly used for these operations: general anaesthesia (where the patient is asleep) and spinal anaesthesia (where the lower part of the body is numbed). Both methods are well established and widely used. Previous studies suggest that the choice of anaesthesia may affect how quickly patients recover, how comfortable they feel after surgery, and whether they can be safely discharged on the day of surgery. However, most existing studies are based on retrospective data, and there is limited randomized evidence comparing these anaesthetic techniques in the outpatient setting.
The GASPS trial is a multicentre, randomized, phase IV clinical study that compares general anaesthesia and spinal anaesthesia in adults undergoing outpatient primary total knee or hip arthroplasty. A total of 600 participants will be included and randomly assigned to receive one of the two anaesthetic methods on the day of surgery. All participants will receive standard surgical and perioperative care, and both anaesthetic techniques are part of routine clinical practice.
The main aim of the study is to investigate whether the type of anaesthesia influences the chance of successful same-day discharge, defined as going home on the day of surgery without needing to be readmitted within 48 hours. The study will also examine recovery time, pain, nausea and vomiting, use of pain medication, complications, patient-reported recovery and function, and healthcare costs. In addition, patient experiences of anaesthesia and postoperative recovery will be explored through interviews in a smaller group of participants.
Participants will be followed using questionnaires and medical records from the day of surgery up to 12 months after the operation. The results of this study are expected to provide clear and reliable information to help guide anaesthetic care for patients undergoing outpatient hip and knee replacement surgery.
Detailed description
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) are among the most frequently performed elective surgical procedures and are highly effective treatments for advanced joint disease, most commonly osteoarthritis. Over the past decade, improvements in surgical techniques, perioperative care pathways, anaesthetic management, and postoperative rehabilitation have enabled an increasing proportion of these procedures to be performed as outpatient surgery, allowing patients to return home on the day of surgery. Outpatient arthroplasty has the potential to improve patient satisfaction, reduce hospital length of stay, lower healthcare costs, and decrease the risk of hospital-acquired complications. However, achieving safe and successful same-day discharge requires carefully optimized perioperative care.
Anaesthetic management is a central component of outpatient arthroplasty pathways. Both general anaesthesia (GA) and spinal anaesthesia (SA) are routinely used for TKA and THA, and both techniques are well established with extensive safety data. Neuraxial anaesthesia has traditionally been associated with reduced intraoperative blood loss and certain postoperative complications, and it is commonly recommended in clinical guidelines for hip and knee arthroplasty. In contrast, modern general anaesthesia using short-acting intravenous agents may offer advantages in the outpatient setting, including predictable onset and offset, rapid recovery of motor function, and reduced postoperative nausea and vomiting when volatile agents are avoided.
Despite widespread clinical use of both techniques, the optimal choice of anaesthesia for outpatient TKA and THA remains uncertain. Much of the existing evidence comparing GA and SA is derived from retrospective observational studies and registry-based analyses. These studies often include mixed inpatient and outpatient populations and are subject to confounding by indication, as patients receiving GA frequently differ from those receiving SA with respect to comorbidity, functional status, or anticipated surgical complexity. As a result, it is difficult to determine whether observed differences in outcomes are attributable to the anaesthetic technique itself or to underlying patient characteristics. Randomized clinical trials specifically designed to compare GA and SA in the outpatient arthroplasty setting are scarce.
The GASPS (General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty) trial was designed to address this evidence gap. GASPS is a multicentre, randomized, phase IV clinical trial comparing GA and SA in adults undergoing outpatient primary TKA or THA. The overarching aim of the trial is to generate high-quality randomized evidence on whether the choice of anaesthetic technique influences the likelihood of successful same-day discharge and postoperative recovery in outpatient arthroplasty.
A total of 600 participants will be enrolled across multiple orthopaedic centres in Sweden. Eligible patients scheduled for outpatient primary TKA or THA are randomized on the day of surgery to receive either GA or SA. Randomization is performed using a stratified permuted block design, with stratification by type of surgery (knee or hip arthroplasty) and study site, to ensure balanced allocation across groups. Allocation concealment is maintained until shortly before surgery. Due to the nature of the interventions, blinding of patients and clinical staff is not feasible; however, data analysts remain blinded during analysis.
Both anaesthetic techniques are delivered according to standardized protocols that reflect contemporary routine clinical practice. General anaesthesia is provided using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, administered by trained anaesthesiologists. Spinal anaesthesia is administered as a single-shot intrathecal block with bupivacaine, with optional intrathecal opioid adjuncts and light sedation as clinically indicated. No experimental drugs or procedures are introduced, and all perioperative care apart from the assigned anaesthetic technique follows local standard practice.
The primary outcome of the trial is successful same-day discharge, defined as discharge from hospital on the day of surgery without readmission within 48 hours. This outcome was chosen as a clinically meaningful and patient-relevant measure of perioperative success in outpatient arthroplasty, integrating both recovery efficiency and short-term safety. Successful same-day discharge reflects the combined effects of anaesthetic technique, surgical care, postoperative recovery, and early complication rates.
Secondary outcomes are designed to capture multiple dimensions of perioperative and postoperative recovery. These include perioperative time metrics related to anaesthesia induction, surgery, and recovery; early postoperative outcomes such as pain, nausea and vomiting, opioid consumption, mobilisation, and adverse events; and patient-reported outcomes assessing quality of recovery, function, and health-related quality of life. Recovery is conceptualized as a multi-phase process, ranging from early recovery in the postoperative care unit to longer-term recovery at home. Validated instruments such as the Quality of Recovery-15 (QoR-15), Knee injury and Osteoarthritis Outcome Score (KOOS), Hip disability and Osteoarthritis Outcome Score (HOOS), and EQ-5D-5L are used to assess these domains over time.
In addition to quantitative outcomes, the GASPS trial incorporates a qualitative component to explore patient experiences of anaesthesia and postoperative recovery. Semi-structured interviews are conducted with a subset of participants several weeks after surgery. This mixed-methods approach allows for a deeper understanding of patient perceptions, expectations, and experiences that may not be fully captured by standardized questionnaires, and provides important contextual information to complement clinical and patient-reported outcome data.
Participants are followed from the day of surgery up to 12 months postoperatively using a combination of medical record review and patient-completed questionnaires. Safety monitoring focuses on adverse events occurring in the immediate perioperative period, while longer-term follow-up captures functional outcomes, quality of life, healthcare utilization, and productivity losses. A health economic evaluation is embedded within the trial to compare GA and SA in terms of costs and quality-adjusted life years, with the aim of informing resource-efficient anaesthetic strategies for outpatient arthroplasty.
By integrating randomized clinical data, patient-reported outcomes, qualitative insights, and health economic analyses, the GASPS trial aims to provide a evaluation of the role of anaesthetic technique in outpatient total knee and hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia (GA) | Experimental | Drug: General AnaesthesiaParticipants randomized to this arm will receive general anaesthesia during outpatient primary total knee or total hip arthroplasty. General anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil, delivered intravenously according to routine clinical practice. Perioperative care apart from the assigned anaesthetic technique follows standard clinical protocols at each study site. |
| Spinal Anaesthesia (SA) | Experimental | Drug: Spinal Anesthesia (bupivacaine)Participants randomized to this arm will receive spinal anaesthesia during outpatient primary total knee or total hip arthroplasty. Spinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine. Optional intrathecal opioid adjuncts and light intravenous sedation may be used at the discretion of the anaesthesiologist to ensure patient comfort. All other perioperative care follows standard clinical practice at each study site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The participant has given their written consent to participate in the trial.
- Planned for primary TKA or THA.
- Adults aged 18 to 80 years at time of written consent.
- ASA (American Society of Anaesthesiologists) classification 1 or 2, or 3 without significant functional impairment.
- Scheduled start of surgery before 13:00.
Key exclusion criteria (12 listed)
- Indication for surgery other than degenerative or inflammatory joint diseases (e.g. fracture).
- Body mass index (BMI) > 35 kg/m.
- Preoperative opioid use exceeding 20 mg oral morphine equivalents daily.
- Haemoglobin < 120 g/L (sample no older than 3 months).
- Known bleeding disorders, including coagulopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General AnaesthesiaAlso: Total Intravenous Anaesthesia, TIVA, Propofol-Remifentanil AnaesthesiaGeneral anaesthesia is administered using total intravenous anaesthesia with short-acting agents, primarily propofol and remifentanil. Anaesthesia is delivered intravenously using target-controlled or rate-controlled infusion systems according to routine clinical practice. Airway management and adjunct medications are provided as clinically indicated. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site. | Drug | General Anaesthesia (GA) |
| Spinal Anesthesia (bupivacaine)Also: Neuraxial Anaesthesia, Spinal Block, Intrathecal AnaesthesiaSpinal anaesthesia is administered as a single-shot intrathecal injection of bupivacaine prior to surgery. Optional intrathecal opioid adjuncts, with fentanyl or sufentanil, may be used to enhance analgesia according to routine clinical practice. Light intravenous sedation may be provided if needed for patient comfort. The intervention is limited to the intraoperative period, and all other perioperative care follows standard clinical protocols at each study site. | Drug | Spinal Anaesthesia (SA) |
Primary outcome
Successful Same-Day Discharge
Time frame: Day of surgery to 48 hours after discharge
Successful same-day discharge is defined as discharge from the hospital on the day of surgery without readmission within 48 hours after discharge. Discharge readiness is assessed by the treating clinical team according to routine clinical criteria. Readmissions are identified through medical record review and patient follow-up.
14 secondary outcomes
Time From Start of Anaesthesia to Start of Surgery
Time frame: Day of surgery
Time to Discharge From Post-Anaesthesia Care Unit (PACU)
Time frame: From intervention to time of discharge from PACU
Time to Fulfilment of Hospital Discharge Criteria
Time frame: During the hospital stay for surgery.
Time to First Successful Mobilisation
Time frame: During the hospital stay for surgery.
Opioid Consumption
Time frame: Day of surgery to postoperative day 35
Quality of Recovery (QoR-15)
Time frame: Postoperative day 1 to postoperative day 35
Postoperative Pain
Time frame: Day of surgery to postoperative day 35
Pain during recovery
Time frame: Baseline and, postoperative day 1 to postoperative day 35
Functional Outcome After Surgery
Time frame: Baseline, 4 weeks, 6 months, and 12 months postoperatively
Adverse Events and Serious Adverse Events
Time frame: Start of anaesthesia to postoperative day 3
Predefined adverse outcomes
Time frame: Day of surgery to 35 days postoperativly
Blood transfusions
Time frame: During the hospital stay for surgery.
Patient Experiences of Anaesthesia and Recovery
Time frame: 14 to 60 days after surgery
Cost-Effectiveness (Incremental Cost-Effectiveness Ratio)
Time frame: Baseline to 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 39425955World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants. JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.
- BackgroundBraun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. januari 2006;3(2):77-101.
- Background: PubMed 32577469Gibon E, Parvataneni HK, Prieto HA, Photos LL, Stone WZ, Gray CF. Outpatient total knee arthroplasty: is it economically feasible in the hospital setting? Arthroplast Today. 2020 Mar 13;6(2):231-235. doi: 10.1016/j.artd.2020.02.004. eCollection 2020 Jun.
- Background: PubMed 28234591Huang A, Ryu JJ, Dervin G. Cost savings of outpatient versus standard inpatient total knee arthroplasty. Can J Surg. 2017 Feb;60(1):57-62. doi: 10.1503/cjs.002516.
- Background: PubMed 30265638Churchill L, Pollock M, Lebedeva Y, Pasic N, Bryant D, Howard J, Lanting B, Laliberte Rudman D. Optimizing outpatient total hip arthroplasty: perspectives of key stakeholders. Can J Surg. 2018 Dec 1;61(6):370-376. doi: 10.1503/cjs.016117.
- Background: PubMed 30143333Kelly MP, Calkins TE, Culvern C, Kogan M, Della Valle CJ. Inpatient Versus Outpatient Hip and Knee Arthroplasty: Which Has Higher Patient Satisfaction? J Arthroplasty. 2018 Nov;33(11):3402-3406. doi: 10.1016/j.arth.2018.07.025. Epub 2018 Aug 1.
- Background: PubMed 29506929Gauthier-Kwan OY, Dobransky JS, Dervin GF. Quality of Recovery, Postdischarge Hospital Utilization, and 2-Year Functional Outcomes After an Outpatient Total Knee Arthroplasty Program. J Arthroplasty. 2018 Jul;33(7):2159-2164.e1. doi: 10.1016/j.arth.2018.01.058. Epub 2018 Feb 5.
- Background: PubMed 28641966Greimel F, Maderbacher G, Zeman F, Grifka J, Meissner W, Benditz A. No Clinical Difference Comparing General, Regional, and Combination Anesthesia in Hip Arthroplasty: A Multicenter Cohort-Study Regarding Perioperative Pain Management and Patient Satisfaction. J Arthroplasty. 2017 Nov;32(11):3429-3433. doi: 10.1016/j.arth.2017.05.038. Epub 2017 May 26.
- Background: PubMed 30470465Nilsson U, Jaensson M, Dahlberg K, Hugelius K. Postoperative Recovery After General and Regional Anesthesia in Patients Undergoing Day Surgery: A Mixed Methods Study. J Perianesth Nurs. 2019 Jun;34(3):517-528. doi: 10.1016/j.jopan.2018.08.003. Epub 2018 Nov 20.
- Background: PubMed 19130163Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after total knee arthroplasty? Clin Orthop Relat Res. 2009 Sep;467(9):2379-402. doi: 10.1007/s11999-008-0666-9. Epub 2009 Jan 7.
- Background: PubMed 31903575Nilsson U, Gruen R, Myles PS. Postoperative recovery: the importance of the team. Anaesthesia. 2020 Jan;75 Suppl 1:e158-e164. doi: 10.1111/anae.14869.
- Background: PubMed 17284272Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing General Anaesthesia and Spinal Anesthesia (bupivacaine) in people with Osteo Arthritis Knee and Hip and Osteo Arthritis, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Noppa, MD (+46 19-602 03 15, erik.noppa@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Same-Day Discharge (time frame: Day of surgery to 48 hours after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334132, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.