Knee OsteoarthritisNCT03364088
Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia
A study testing Spinal anesthesia with tourniquet, Spinal anesthesia without tourniquet and General anesthesia with tourniquet in people with Knee Osteoarthritis and Arthropathy of Knee Joint, run by Riku Antero Palanne at 1 site in Finland.
Trial summary
Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Arthropathy of Knee Joint, Knee Pain Chronic
- What is being tested?
- Spinal anesthesia with tourniquet, Spinal anesthesia without tourniquet and General anesthesia with tourniquet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteFinland
- Study dates
- 3 Oct 2016to 3 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for total knee arthroplasty exists (patient has osteoarthritis, rheumatoid arthritis or other disease affecting knee joint that does not respond to conservative treatment)
- Patient understands the study information and is willing to participate
- Triathlon endoprosthesis is suitable for patient
- ASA Physical Status Classification 1-3
- Patient will be operated by a surgeon who has done at least 100 total knee arthroplasty procedures with Triathlon endoprosthesis before
Who cannot join
- BMI > 40 kg/m2
- ASA Physical Status Classification > 3
- Valgus or varus > 15° degrees in the knee that will be operated
- Extension deficit ≥ 20° or flexion ≤ 90° in the knee that will be operated
- Earlier major (open) surgery in the knee that will be operated
- Contraindication for drugs used in the study
Show all 13Show fewer
- Contraindication for either spinal or general anesthesia
- Glomerular filtration rate < 60ml/min/1.73m2 (by Chronic Kidney DIsease Epidemiology Collaboration formula)
- Known or suspected disease affecting the function of liver
- Preoperative use of strong opioids
- Patient is pregnant, cognitively disabled, under guardianship, a prisoner or in compulsory military service
- Patient will be operated by a surgeon who has done less than 100 total knee arthroplasty procedures before or by a surgeon who does not operate with Triathlon endoprosthesis
- Day of the surgery is not suitable for study (no research personnel available for 24 hours postoperative evaluation)
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University Central Hospital, Peijas hospital
Vantaa, 00029
About this study
Official title: Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial
Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. In Finland, total knee arthroplasty has typically been performed under spinal anesthesia.
In a recent prospective randomized controlled study, total knee arthroplasty under general anesthesia resulted in less acute postoperative pain (opioid-need measured by patient-controlled anesthesia), less nausea, and faster hospital discharge than that performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh muscles and thus hinder mobilization. In a recent study, both techniques with and without surgical tourniquet appeared equal.
Read more
The aims of this study are to compare total knee arthroplasty under spinal or general anesthesia, with or without surgical tourniquet, in relation to acute and chronic postoperative pain, nausea, knee function, patient reported quality of life and satisfaction on care, complications, length of stay, and need of surgical unit resources. This randomized controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA) physical status classification I-III, body mass index under 40, and no contraindications for medications or treatments used.
The hypothesis of this study are used to reassess best practices of primary total knee arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and availability of surgery due to better patient flow at surgical unit.
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee Joint, Knee Pain Chronic, Rheumatoid Arthritis, Anesthesia
- Being tested
- Spinal anesthesia with tourniquet, Spinal anesthesia without tourniquet, General anesthesia with tourniquet, General anesthesia without tourniquet, Oxycodone by patient-controlled analgesia (PCA)
- Keywords
- Total knee arthroplasty, Anesthesia, Surgical tourniquet, Pain, Postoperative nausea and vomiting, Quality of life, Length of stay, Knee function, Bioelectrical impedance, Knee endoprosthesis
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Rheumatoid, Pain, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with tourniquetProcedure or surgery
Operation is done under spinal anesthesia and surgical tourniquet is used.
Spinal anesthesia without tourniquetProcedure or surgery
Operation is done under spinal anesthesia and without the use of surgical tourniquet.
General anesthesia with tourniquetProcedure or surgery
Operation is done under general anesthesia and surgical tourniquet is used.
General anesthesia without tourniquetProcedure or surgery
Operation is done under general anesthesia and without the use of surgical tourniquet.
Oxycodone by patient-controlled analgesia (PCA)Drug
PCA device (CADD Legacy PCA Pump, Smiths Medical, Kent, UK) is programmed to give intravenous oxycodone in doses of 0.04 mg/kg (ideal body weight). The minimum time between doses is set to 10 minutes and no more than 4 doses per hour are allowed.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia with tourniquet | Active comparator | This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of the tourniquet.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. Receives: Procedure: Spinal anesthesia with tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA) |
| Spinal anesthesia without tourniquet | Active comparator | This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet is not used during the operation.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. Receives: Procedure: Spinal anesthesia without tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA) |
| General anesthesia with tourniquet | Active comparator | This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) and surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation.
Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of tourniquet. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. Receives: Procedure: General anesthesia with tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA) |
| General anesthesia without tourniquet | Active comparator | This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) without the use of surgical tourniquet.
Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins.
Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. Receives: Procedure: General anesthesia without tourniquet; Drug: Oxycodone by patient-controlled analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.
Measured: 24 hours postoperative
Secondary outcomes (14)
Acute postoperative pain
Patient reported pain (supine at rest, with knee straight and hip in 45 degrees flexion, with knee at 45 degrees flexion and after walking 5 meters) by numerical rating scale (NRS; a whole number from 0 to10 where 0 = no pain and 10 = worst possible pain) 24 hours postoperative.
Measured: 24 hours postoperative
Postoperative nausea
Patient reported nausea by numerical rating scale (NRS; a whole number from 0 to10 where 0 = no nausea and 10 = worst possible nausea) before transferring from recovery room to surgical ward and 24 hours postoperative.
Measured: an average of 0-3 hours and 24 hours postoperative
Medications given for postoperative nausea and vomiting (PONV)
The number of medications given for PONV during postoperative hospital stay.
Measured: an average of 2 to 3 days postoperative
Chronic postoperative pain
Differences in Brief Pain Inventory Short Form (BPI-SF) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.
Measured: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Predictive value of chronic pain risk index
4 out of 5 risk factors described by Althaus et al. are asked during preoperative visit and 1 out of 5 risk factors will be assessed 24 hours postoperative. These results will be compared to results from BPI-SF questionnaires.
Measured: an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative
Knee function
Differences in Oxford knee score (OKS) questionnaires self-reported By patients preoperatively and 3 and 12 months postoperatively.
Measured: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Self-reported quality of life
Differences in 15-dimensional, generic, standardized, self-administered measure of health-related quality of life (15D) questionnaires self-reported by patients preoperatively and 3 and 12 months postoperatively.
Measured: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Patient satisfaction and self-reported complications
A patient-reported outcome measures (PROM) questionnaire made for this study including 10 questions about patient satisfaction and possible complications at 3 and 12 months postoperatively.
Measured: 3 and 12 months postoperative
Times at the operation unit
Time (in minutes) spent for managing anesthesia and surgery, in the operating room and in the recovery room. Information is gathered from electrical anesthesia management program.
Measured: from operating room to end of treatment in recovery room, an average of 3-5 hours
Need for "rescue" analgesia
Proportion of patients needing "rescue" analgesia in form of medications and regional anesthetic techniques outside the study protocol during the postoperative hospital stay.
Measured: From recovery room to the end of hospital stay, an average of 2-3 days
Need for vasoactive medications, urine catheter and ventilatory support
Proportion of patients needing vasoactive medications intra- or postoperatively and patients needing urine catheter or ventilatory support postoperatively.
Measured: intraoperative - an average of 2-3 days
Bleeding
The amount of bleeding during the operation and the change in blood hemoglobin level.
Measured: 3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative
Complications
Recorded complications derived from patient information systems up to 12 months postoperative.
Measured: 12 months postoperative
Hospital length of stay
Time from the start of operation to the time when patient meets the hospital discharge criteria and time when patient is actually discharged.
Measured: an average of 2 to 3 days up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start3 Oct 2016
- Primary completion22 Dec 2018
- Study completion3 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riku Antero Palanne
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, Finland
- Responsible party
- Sponsor-investigator, Riku Antero Palanne, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364088
- Sponsor's protocol ID
- PeijasTKA
- Status last verified
- Jan 2020
- First submitted
- 30 Oct 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
PubMed 22337572Rantasalo MT, Palanne R, Juutilainen K, Kairaluoma P, Linko R, Reponen E, Helkamaa T, Vakkuri A, Olkkola KT, Madanat R, Skants NKA. Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol. BMJ Open. 2018 Dec 22;8(12):e025546. doi: 10.1136/bmjopen-2018-025546.
PubMed 30580277
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Total Knee Arthroplasty Under General or Spinal Anesthesia, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03364088
- Acronym / sponsor ID
- PeijasTKA
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee Joint, Knee Pain Chronic, Rheumatoid Arthritis, Anesthesia
- Keywords
- Total knee arthroplasty, Anesthesia, Surgical tourniquet, Pain, Postoperative nausea and vomiting, Quality of life, Length of stay, Knee function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Riku Antero PalanneUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki, Finland
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 22 Dec 2018 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 6 Dec 2017 (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.
Previous retrospective database studies suggest that total knee arthroplasty (TKA) surgery under spinal anesthesia has less complications than when performed under general anesthesia. In general, complications are rare and both anesthesia types are widely accepted. In Finland, total knee arthroplasty has typically been performed under spinal anesthesia.
In a recent prospective randomized controlled study, total knee arthroplasty under general anesthesia resulted in less acute postoperative pain (opioid-need measured by patient-controlled anesthesia), less nausea, and faster hospital discharge than that performed under spinal anesthesia. Also the use of surgical tourniquet can affect surgical outcome: it may reduce bleeding and surgery time, but it may also cause weakness of thigh muscles and thus hinder mobilization. In a recent study, both techniques with and without surgical tourniquet appeared equal.
The aims of this study are to compare total knee arthroplasty under spinal or general anesthesia, with or without surgical tourniquet, in relation to acute and chronic postoperative pain, nausea, knee function, patient reported quality of life and satisfaction on care, complications, length of stay, and need of surgical unit resources. This randomized controlled study includes 400 patients with informed consent, 18-75-years-of-age, standard primary total knee arthroplasty operation, American Society of Anesthesiologist (ASA) physical status classification I-III, body mass index under 40, and no contraindications for medications or treatments used.
The hypothesis of this study are used to reassess best practices of primary total knee arthroplasty operation to enhance quality of care, patient outcomes and satisfaction, and availability of surgery due to better patient flow at surgical unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia with tourniquet | Active comparator | Procedure: Spinal anesthesia with tourniquet, Drug: Oxycodone by patient-controlled analgesia (PCA)This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation. Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of the tourniquet. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. |
| Spinal anesthesia without tourniquet | Active comparator | Procedure: Spinal anesthesia without tourniquet, Drug: Oxycodone by patient-controlled analgesia (PCA)This group will be operated under spinal anesthesia (15 mg of bupivacaine) and in continuous light propofol sedation. Surgical tourniquet is not used during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. |
| General anesthesia with tourniquet | Active comparator | Procedure: General anesthesia with tourniquet, Drug: Oxycodone by patient-controlled analgesia (PCA)This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) and surgical tourniquet (with the pressure of 250 mmHg or > 100 mmHg higher than systolic blood pressure) is used during the operation. Local infiltration analgesia (LIA) will be administered during the operation. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the removal of tourniquet. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. |
| General anesthesia without tourniquet | Active comparator | Procedure: General anesthesia without tourniquet, Drug: Oxycodone by patient-controlled analgesia (PCA)This group will be operated under general anesthesia (propofol and remifentanil are used with target-controlled infusion (TCI) mode) without the use of surgical tourniquet. Patients receive 1 g of intravenous tranexamic acid approximately 5 - 10 minutes before the surgical incision. Local infiltration analgesia (LIA) will be administered during the operation. Intravenous bolus of oxycodone 0.1 mg/kg (ideal body weight) is given when the closure of surgical wound begins. Postoperatively patient-controlled analgesia (PCA) with intravenous oxycodone will be used for 24 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indication for total knee arthroplasty exists (patient has osteoarthritis, rheumatoid arthritis or other disease affecting knee joint that does not respond to conservative treatment)
- Patient understands the study information and is willing to participate
- Triathlon endoprosthesis is suitable for patient
- ASA Physical Status Classification 1-3
- Patient will be operated by a surgeon who has done at least 100 total knee arthroplasty procedures with Triathlon endoprosthesis before
Key exclusion criteria (13 listed)
- BMI > 40 kg/m2
- ASA Physical Status Classification > 3
- Valgus or varus > 15° degrees in the knee that will be operated
- Extension deficit ≥ 20° or flexion ≤ 90° in the knee that will be operated
- Earlier major (open) surgery in the knee that will be operated
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 |
|---|---|---|
| Spinal anesthesia with tourniquetOperation is done under spinal anesthesia and surgical tourniquet is used. | Procedure or surgery | Spinal anesthesia with tourniquet |
| Spinal anesthesia without tourniquetOperation is done under spinal anesthesia and without the use of surgical tourniquet. | Procedure or surgery | Spinal anesthesia without tourniquet |
| General anesthesia with tourniquetOperation is done under general anesthesia and surgical tourniquet is used. | Procedure or surgery | General anesthesia with tourniquet |
| General anesthesia without tourniquetOperation is done under general anesthesia and without the use of surgical tourniquet. | Procedure or surgery | General anesthesia without tourniquet |
| Oxycodone by patient-controlled analgesia (PCA)PCA device (CADD Legacy PCA Pump, Smiths Medical, Kent, UK) is programmed to give intravenous oxycodone in doses of 0.04 mg/kg (ideal body weight). The minimum time between doses is set to 10 minutes and no more than 4 doses per hour are allowed. | Drug | General anesthesia with tourniquet, General anesthesia without tourniquet, Spinal anesthesia with tourniquet, Spinal anesthesia without tourniquet |
Primary outcome
Opioid consumption
Time frame: 24 hours postoperative
Cumulative intravenous oxycodone consumption By patient controlled analgesia (PCA) 24 hours postoperative.
14 secondary outcomes
Acute postoperative pain
Time frame: 24 hours postoperative
Postoperative nausea
Time frame: an average of 0-3 hours and 24 hours postoperative
Medications given for postoperative nausea and vomiting (PONV)
Time frame: an average of 2 to 3 days postoperative
Chronic postoperative pain
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Predictive value of chronic pain risk index
Time frame: an average of 1-2 weeks preoperative and 24 hours, 3 months and 12 months postoperative
Knee function
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Self-reported quality of life
Time frame: an average of 1-2 weeks preoperative, 3 and 12 months postoperative
Patient satisfaction and self-reported complications
Time frame: 3 and 12 months postoperative
Times at the operation unit
Time frame: from operating room to end of treatment in recovery room, an average of 3-5 hours
Need for "rescue" analgesia
Time frame: From recovery room to the end of hospital stay, an average of 2-3 days
Need for vasoactive medications, urine catheter and ventilatory support
Time frame: intraoperative - an average of 2-3 days
Bleeding
Time frame: 3 months to 1 day preoperative, intraoperative, 15-24 hours postoperative
Complications
Time frame: 12 months postoperative
Hospital length of stay
Time frame: an average of 2 to 3 days up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 22337572Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
- Derived from this study: PubMed 30580277Rantasalo MT, Palanne R, Juutilainen K, Kairaluoma P, Linko R, Reponen E, Helkamaa T, Vakkuri A, Olkkola KT, Madanat R, Skants NKA. Randomised controlled study comparing general and spinal anaesthesia with and without a tourniquet on the outcomes of total knee arthroplasty: study protocol. BMJ Open. 2018 Dec 22;8(12):e025546. doi: 10.1136/bmjopen-2018-025546.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anesthesia with tourniquet, Spinal anesthesia without tourniquet and General anesthesia with tourniquet in people with Knee Osteoarthritis and Arthropathy of Knee Joint, run by Riku Antero Palanne at 1 site in Finland.
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 5 inclusion and 13 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 24 hours postoperative). 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 NCT03364088, which also lists 2 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 13 Jan 2020.