Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
NCT ID: NCT03756961
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
220 participants
INTERVENTIONAL
2019-05-01
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The overall aim is to evaluate the short-, medium- and long-term effects of opioid-free care pathways with or without person-centred care compared to conventional opioid-based treatment in patients undergoing obesity surgery.
Specific aims
1. Determine the effects of opioid-free care with or without person-centred care compared with conventional opioid-based general anaesthesia on the cognitive and physical quality of recovery after surgery up to 24 months after surgery (short-term: postoperative to discharge, medium-term: 14 days, 3 months, long-term: 6 months, 12 months and 24 months).
2. Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.
3. Map the impact of opioid-free anaesthesia (with and without person-centred care) on the usage of opioids up to 24 months after hospital discharge.
4. Explore the patients' experience of quality of life, economic evaluations, self-efficacy and recovery after surgery in opioid-free care with or without person-centred care during the first year post-surgery.
The aims will be evaluated by a prospective, randomized, non-blinded, non-commercial multi-centre study (Nov 2018-Dec 2022) approved by the Swedish Medicines Agency (EU-CT 2023-505934-86-00) and the ethical review board (DNR 1006-17).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Opioid Free Anesthesia in Obese Patients.
NCT05481970
Benefits of Opioid Free Anesthesia on Morphine Consumption in Gastric Bypass
NCT05004519
Impact of Daily, Digital and Behavioral Tele-health Tapering Program for Perioperative Surgical Patients Exposed to Opioids and Benzodiazepines.
NCT04787692
Effect of Opioid-sparing Anesthesia on Quality of Recovery After Emergency Laparotomy
NCT07262242
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture
NCT00529425
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis 1. An opioid-free care pathway provides non-inferior pain relief as the conventional care with opioids during the post-operative phase.
Primary endpoints: Determine the quality of recovery after surgery
1\. No difference in pain (NRS pain (0-10)) between opioid-free intervention with or without (Phase 1 \& 2) person-centred care and conventional treatment (control group) during the postoperative phase until discharge to the surgical ward.
Secondary endpoints:
An opioid-sparing treatment provides improved combined outcomes (composite score) consisting of 1) Self-Efficacy, 2) Postoperative Quality of Recovery Scale (PQRS), hospital readmission, or death at 3 months compared to conventional treatment.
An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment.
An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment.
An opioid-sparing treatment results in decreased pain experience according to the Numeric Rating Scale (NRS) at 3 months and 6 months compared to conventional treatment.
An opioid-sparing treatment leads to earlier recovery after surgery measured with PQRS compared to conventional treatment postoperatively (20 minutes, 40 minutes), during hospitalization (24-72 hours), and thereafter (14 days, 30 days, 3 months, 6 months, 12 months, and 24 months).
An opioid-sparing treatment increases confidence in coping with unexpected events measured with the General Self-Efficacy Scale compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months).
An opioid-sparing treatment improves quality of life measured with RAND-36 and EQ5D compared to conventional treatment after the in-hospital period (3 months, 6 months, 12 months, 24 months)
An opioid-sparing treatment results in equivalent length of hospital stay compared to conventional treatment during the in-hospital period.
Mapping of long-term prescription of analgesic drugs. Does an opioid-sparing treatment impact the long-term use of analgesic medications.
Explorative endpoints:
Describe the intraoperative nociception level between opioid-free anaesthesia and conventional anaesthesia using the Medasense PMD-200 (NOL) monitor.
Economic evaluation: Performing cost-utility analysis/ cost-effectiveness analyses.
Power Pain: To determine noninferiority with a power of 0.8 (i.e., the probability of \> 0.8 for the lower limit of a two-sided 95% confidence interval (using Fisher's nonparametric permutation test)), the difference of change in pain using the NRS from arrival to the recovery unit after surgery to discharge from the recovery unit will be used. Forty-three patients are required in each group and phase, with an SD for the change in the NRS estimated to be 1.62 from a small pilot study (noninferiority margin -1.0). The estimated change was assumed to be equal in the groups. To compensate for a potential interruption in the study or dropouts, we chose to include 55 patients in Intervention Phase 1, 55 patients in Intervention Phase 2 and a total of 110 patients in the control group (to follow intervention Phases 1 and 2, each 55 patients).
Recovery after surgery: To detect an overall difference in the quality of recovery between groups over the entire study length, with a power of 0.8 and P \< 0.05 and taking into consideration a dropout of over 30% as seen in other studies using the PQRS, we need to include at least 30 patients in each group 26.
The control group will receive usual care and treatment according to the hospital's routines, where pain relief is obtained with opioids postoperatively. Pharmacological treatment in the intervention group differs solely from the patients in the usual group by replacing opioids with the following nonopioid perioperative treatment: dexmedetomidine, esketamine, lidocaine and TENS (for exact dosing, please visit EU-CT 2023-505934-86-00). Postoperative patient-controlled pain treatment with high-intensity/high-frequency TENS is used if the patient perceives pain over NRS ≧ 3 postoperatively and during remaining hospitalisation.
Intervention Phase 1 tests the pharmacological and non-pharmacological interventions (TENS) compared to the control group that receives standard care with opioids intra- and postoperatively. Phase 2 intervention that follows after completion of Phase 1 intervention tests the pharmacological and nonpharmacological interventions compared to conventional treatment, supplemented by an evidenced-based PCC approach throughout the continuum of postoperative care.
The two phases will primarily be analysed separately (i.e., between the control group and intervention Phase 1 and between the control group and intervention Phase 2).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Control group: The patients receive the routine based anesthesiological treatment during bariatric surgery (Gastric By-Pass or Sleeve Gastrectomy). It consists of:
General anesthesia induction: TCI Remifentanil Cpt 6 ng/ml/ Cp 3.2 ng/m, Propofol 1.5-2 mg/kg iv, Desflurane/Sevuflurane MAC (0.6-0.8).
Maintained by Desflurane MAC (0.6-0.8) adjusted via BIS (40-60) and Remifentanil Cp 4-10 ng/ml.
Post-operative pain management: Oxycodone 2.5 mg iv if the pain is rated by patient NRS ≧3. Paracetamol 1 g/6 h and Diclofenac 80 mg/24 h.
Remifentanil
The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.
Desflurane
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
Propofol
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
Oxycodone
The control group receives Oxycodone as the routine pain management drug post-operative.
Intervention
Induction: Dexmedetomidine 0.2 micrograms/kg/h iv 5 min+16 mcg, Esketamine 0.1mg/kg + Propofol 1.5-2 mg/kg iv, Desflurane/Sevuflurane MAC (0.6-0.8).
Maintained by Desflurane/Sevuflurane MAC (0.6-0.8) BIS (40-60), Dexmedetomidine 0.2 micrograms/kg/h, Esketamine 0.1-0.3mg/kg/h och 0.1 mg/kg in case of hypertension. End of surgery, Lidocaine 1 mg/kg iv (max 4 mg/kg /4 h), Midazolam 0.5mg
Post-operative: Dexmedetomidine (0.1-0.2 micrograms/kg/h up to 4 h post-operative). If the pain is rated NRS ≧3: Transcutaneous Nerve Stimulation (TENS) with high intensive 40-50 mA for 1 minute, if the patient still NRS ≧3, the TENS treatment is repeated one more time. If pain NRS ≧3 after two treatments with TENS: Esketamine 0.1mg/kg iv + Lidocaine 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS still ≧3 within 30 minutes after both TENS and Esketamine/Lidocaine, 2.5 mg Oxycodone iv until NRS \< 3. Perioperative and at discharge, PCC will be used for the the intervention (Phase 2 patients)
Dexmedetomidine
The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Person-centred care (PCC)
The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge. This will be part of patients in Phase 2
Esketamine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Lidocaine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment.
Transcutaneous Nerve Stimulation (TENS)
The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.
Desflurane
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
Propofol
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine
The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Person-centred care (PCC)
The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge. This will be part of patients in Phase 2
Esketamine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
Lidocaine
The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment.
Transcutaneous Nerve Stimulation (TENS)
The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.
Remifentanil
The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.
Desflurane
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
Propofol
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
Oxycodone
The control group receives Oxycodone as the routine pain management drug post-operative.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Cardiovascular disease with bradycardia (\<50 bpm)
* Serious liver disease failure
* Insufficient knowledge of the Swedish language
* Serious untreated psychiatric disease
* Neurocognitive dysfunction
* Pregnancy
* Women of childbearing age without contraception
* Malignant disease with expected short survival
* Patients treated with opioids for chronic pain
* Substance abuse
* Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine
* Pacemaker or ICD
* Inability to fill in questionnaires
* Decline participation,
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Göteborg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sven-Egron Thörn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Göteborg University
Axel Wolf, RN, PhD, Professor
Role: STUDY_CHAIR
Göteborg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lindesberg Hospital
Lindesberg, Region Örebro, Sweden
Sahlgrenska University hospital/ Östra hopsital
Gothenburg, VG, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Olausson A, Jildenstal P, Andrell P, Angelini E, Stenberg E, Wallenius V, Ohrstrom H, Thorn SE, Wolf A. Effects of an opioid-free care pathway vs. opioid-based standard care on postoperative pain and postoperative quality of recovery after laparoscopic bariatric surgery: A multicentre randomised controlled trial. Eur J Anaesthesiol. 2025 Aug 1;42(8):714-726. doi: 10.1097/EJA.0000000000002193. Epub 2025 May 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-003830-97
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
OS-PCC-2017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.