Analgesics, OpioidNCT06380244
Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery
A study testing anesthesia without opioids in people with Analgesics, Opioid and Anesthesia, Endotracheal, run by Jagiellonian University at 1 site in Poland.
Trial summary
Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesics, Opioid, Anesthesia, Endotracheal, Anesthesia, General
- What is being tested?
- anesthesia without opioids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePoland
- Study dates
- 29 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.
- Ability to operate a patient-controlled analgesia (PCA) pump postoperatively.
- Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment.
- Written informed consent.
Who cannot join
- Patient's refusal to participate.
- Inability to operate the PCA pump.
- Inability to understand the NRS pain scale.
- Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen).
- Second- or third-degree atrioventricular block, or symptomatic bradycardia.
- Chronic opioid use.
- Contraindication to the planned regional anesthesia technique (e.g. coagulopathy or therapeutic anticoagulation, infection at the puncture site).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Jagiellonian University
Krakow, Lesser Poland Voivodeship, 31501
Tomasz Skladzien, phd md, 506602250 ext. 48, t.skladzien@interia.pl
About this study
Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery.
This randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy.
Read more
The PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups.
SECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses.
PRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots.
Planned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.
Read the detailed description
All consecutive patients undergoing elective urological surgery (laparoscopic or robotic nephrectomy, prostatectomy, or cystectomy) will be randomly divided into two groups: one under completely opioid-free anesthesia (infusion of ketamine, lidocaine and dexmedetomidine, with inhalation of sevoflurane) and the other under combined general anesthesia (using an infusion of remifentanil intraoperatively). In the postoperative period, all patients will receive oxycodone in a PCA pump or in the form of oral tablets [oxycodone hydrochloride + naloxone hydrochloride] and co-analgesics in the form of paracetamol and metamizole.
Opioid-free general anesthesia is a recognized method used during anesthesia. It allows participants to effectively control pain, reducing the number of complications associated with taking large doses of opioid drugs. It should be emphasized that it is approved for use in routine anesthetic practice, and whether such a technique is used in a given patient depends on the experience, knowledge and preferences of the anesthesiologist. It is used in everyday anesthetic practice, but there is no conclusive scientific data confirming its advantage in patients undergoing major urological surgery.
Mulier et al. proposed an OFA scheme including dexmedetomidine, ketamine and lidocaine for the induction of anesthesia, ensuring sedation, analgesia and sympatholytic therapy, followed by a maintenance infusion of lidocaine and dexmedetomidine. The protocol proposed by Mulier et al. is widely used and accepted worldwide. Initially used in patients undergoing bariatric procedures, it was subsequently extended to other types of surgical procedures.
In the postoperative period, pain will be assessed using the NRS scale at 1, 2, 6, 12, and 24 hours after the procedure. Serum creatinine and white blood cell (WBC) count will be measured preoperatively (baseline) and on postoperative day 1.
- Being tested
- anesthesia without opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia without opioidsOther
Opioid free general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Opioid-based anesthesia (remifentanil) | No intervention | Opioid-based general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Induction with propofol and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by remifentanil infusion (total intraoperative dose recorded). Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole. |
| Opioid-free anesthesia (OFA) | Experimental | Opioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine (OFA group only). Induction with propofol, ketamine (OFA group only), and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by a continuous dexmedetomidine/ketamine infusion with rescue boluses for tachycardia or hypertension. Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole. Receives: Other: anesthesia without opioids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative oxycodone dose administered via PCA (mg)
Total postoperative oxycodone dose administered via PCA (mg) - Cumulative dose of oxycodone (mg) self-administered via PCA pump during the first 24 hours after surgery, compared between the OFA and remifentanil groups.
Measured: 0-24 hours after surgery
Secondary outcomes (1)
Postoperative pain (NRS)
Postoperative pain intensity as assessed by the Numeric Rating Scale (NRS) - NRS (0 = no pain, 10 = worst imaginable pain) at rest, compared between groups; score reported at each time point.
Measured: 1, 2, 6, 12, and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start29 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesics, OpioidStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380244
- Sponsor's protocol ID
- 1072.6120.136.2023
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share demografic data, type of surgery, score in NRS and opioid consumption dosage.
Publications
Skladzien T, Zmuda A, Cicio M, Kowal T, Kwinta A, Bugielska R, Szpunar W, Szpor J, Maciejewska K, Swistek R, Lonc T, Drygalski T, Maciejewski P. Opioid-free versus opioid-based anesthesia for robot-assisted radical prostatectomy: a single-center randomized controlled trial. J Robot Surg. 2026 Oct 13;20(1):1101. doi: 10.1007/s11701-026-04028-7.
PubMed 42867736
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-free Anesthesia as an Alternative to General Anesthesia in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06380244
- Acronym / sponsor ID
- 1072.6120.136.2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Apr 2024 (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.
Opioid-free anesthesia (OFA) is a multimodal technique that eliminates intraoperative opioids by combining dexmedetomidine, ketamine, lidocaine, NSAIDs, and regional analgesia. Growing evidence suggests OFA reduces postoperative opioid consumption, opioid-related adverse effects, and may have favorable oncological implications in cancer surgery.
This randomized controlled trial compares OFA with opioid-based anesthesia (remifentanil) in patients undergoing elective urological surgery: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy.
The PRIMARY OBJECTIVE is to compare the total postoperative oxycodone dose (mg) administered via patient-controlled analgesia (PCA) during the first 24 hours after surgery between the OFA and remifentanil groups.
SECONDARY OBJECTIVES include: postoperative pain intensity (NRS) at 1, 2, 6, 12, and 24 hours; incidence of postoperative nausea and vomiting (PONV); change in serum creatinine from baseline to postoperative day 1; change in white blood cell (WBC) count from baseline to postoperative day 1; and the ratio of demanded to delivered PCA boluses.
PRE-SPECIFIED SUBGROUP ANALYSES will compare outcomes by surgical procedure type: laparoscopic nephrectomy, robotic nephrectomy, laparoscopic prostatectomy, robotic prostatectomy, laparoscopic cystectomy, and robotic cystectomy. Subgroup-by-treatment interaction tests will be performed and reported as forest plots.
Planned enrollment: approximately 600 patients (300 per arm). Follow-up: 24 hours postoperatively.
Detailed description
All consecutive patients undergoing elective urological surgery (laparoscopic or robotic nephrectomy, prostatectomy, or cystectomy) will be randomly divided into two groups: one under completely opioid-free anesthesia (infusion of ketamine, lidocaine and dexmedetomidine, with inhalation of sevoflurane) and the other under combined general anesthesia (using an infusion of remifentanil intraoperatively). In the postoperative period, all patients will receive oxycodone in a PCA pump or in the form of oral tablets [oxycodone hydrochloride + naloxone hydrochloride] and co-analgesics in the form of paracetamol and metamizole.
Opioid-free general anesthesia is a recognized method used during anesthesia. It allows participants to effectively control pain, reducing the number of complications associated with taking large doses of opioid drugs. It should be emphasized that it is approved for use in routine anesthetic practice, and whether such a technique is used in a given patient depends on the experience, knowledge and preferences of the anesthesiologist. It is used in everyday anesthetic practice, but there is no conclusive scientific data confirming its advantage in patients undergoing major urological surgery.
Mulier et al. proposed an OFA scheme including dexmedetomidine, ketamine and lidocaine for the induction of anesthesia, ensuring sedation, analgesia and sympatholytic therapy, followed by a maintenance infusion of lidocaine and dexmedetomidine. The protocol proposed by Mulier et al. is widely used and accepted worldwide. Initially used in patients undergoing bariatric procedures, it was subsequently extended to other types of surgical procedures.
In the postoperative period, pain will be assessed using the NRS scale at 1, 2, 6, 12, and 24 hours after the procedure. Serum creatinine and white blood cell (WBC) count will be measured preoperatively (baseline) and on postoperative day 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Opioid-based anesthesia (remifentanil) | No intervention | –Opioid-based general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, and ibuprofen. Induction with propofol and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by remifentanil infusion (total intraoperative dose recorded). Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole. |
| Opioid-free anesthesia (OFA) | Experimental | Other: anesthesia without opioidsOpioid-free general anesthesia. Premedication includes dexamethasone, paracetamol, metamizole, magnesium sulfate, ibuprofen, and dexmedetomidine (OFA group only). Induction with propofol, ketamine (OFA group only), and rocuronium under TOF monitoring. Maintenance with sevoflurane titrated to MAC; intraoperative analgesia provided by a continuous dexmedetomidine/ketamine infusion with rescue boluses for tachycardia or hypertension. Regional analgesia by procedure: bilateral ESP block (nephrectomy), bilateral QL block (prostatectomy), and continuous epidural ropivacaine infusion (cystectomy). Postoperative analgesia: oxycodone PCA (2 mg bolus, 10-min lockout, no background infusion) with paracetamol and metamizole. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-75 years scheduled for elective urological surgery under general anesthesia: laparoscopic or robotic nephrectomy, laparoscopic or robotic prostatectomy, or laparoscopic or robotic cystectomy.
- Ability to operate a patient-controlled analgesia (PCA) pump postoperatively.
- Ability to understand and use the Numeric Rating Scale (NRS) for pain assessment.
- Written informed consent.
Key exclusion criteria (7 listed)
- Patient's refusal to participate.
- Inability to operate the PCA pump.
- Inability to understand the NRS pain scale.
- Known hypersensitivity to any of the study drugs (anesthetics, ketamine, dexmedetomidine, ropivacaine, oxycodone, metamizole, paracetamol, ibuprofen).
- Second- or third-degree atrioventricular block, or symptomatic bradycardia.
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 |
|---|---|---|
| anesthesia without opioidsOpioid free general anesthesia | Other | Opioid-free anesthesia (OFA) |
Primary outcome
Total postoperative oxycodone dose administered via PCA (mg)
Time frame: 0-24 hours after surgery
Total postoperative oxycodone dose administered via PCA (mg) - Cumulative dose of oxycodone (mg) self-administered via PCA pump during the first 24 hours after surgery, compared between the OFA and remifentanil groups.
1 secondary outcome
Postoperative pain (NRS)
Time frame: 1, 2, 6, 12, and 24 hours after surgery
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 26 Aug 2026.
- Derived from this study: PubMed 42867736Skladzien T, Zmuda A, Cicio M, Kowal T, Kwinta A, Bugielska R, Szpunar W, Szpor J, Maciejewska K, Swistek R, Lonc T, Drygalski T, Maciejewski P. Opioid-free versus opioid-based anesthesia for robot-assisted radical prostatectomy: a single-center randomized controlled trial. J Robot Surg. 2026 Oct 13;20(1):1101. doi: 10.1007/s11701-026-04028-7.
- Individual participant dataSharing planned: Yes. We plan to share demografic data, type of surgery, score in NRS and opioid consumption dosage.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anesthesia without opioids in people with Analgesics, Opioid and Anesthesia, Endotracheal, run by Jagiellonian University at 1 site in Poland.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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 Poland. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative oxycodone dose administered via PCA (mg) (time frame: 0-24 hours after surgery). 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 NCT06380244, which also lists 1 linked publication.
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 26 Aug 2026.