ObesityOS-PCCNCT03756961
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
A study testing Dexmedetomidine, Person-centred care (PCC) and Esketamine in people with Obesity and Pain, Postoperative, run by Göteborg University at 2 sites in Sweden.
Trial summary
The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Pain, Postoperative
- What is being tested?
- Dexmedetomidine, Person-centred care (PCC) and Esketamine
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesSweden
- Study dates
- 1 May 2019to 31 Dec 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.
Who cannot join
- ASA> III
- Cardiovascular disease with bradycardia (<50 bpm)
- Serious liver disease failure
- Insufficient knowledge of the Swedish language
- Serious untreated psychiatric disease
- Neurocognitive dysfunction
Show all 15Show fewer
- 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,
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University hospital/ Östra hopsital
Gothenburg, VG, 41678
Axel Wolf, RN/MBA/PhD, +46709355364, axel.wolf@gu.se
Sven-Egron Thörn, MD/PhD, +46 31-343 49 03, sven-egron.thorn@vgregion.se
- Recruiting
Lindesberg Hospital
Lindesberg, Region Örebro, 711 82
Henrik Öhström, MD, +4619-602 03 56, henrik.ohrstrom@regionorebrolan.se
About this study
Official title: Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery
The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy.
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.
Read more
Specific aims
- 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).
- Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.
- 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.
- 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).
Read the detailed description
Aim To evaluate the effects of opioid sparing care pathways compared to conventional opioid-based treatment for pain relief, opioid consumption, recovery after surgery, self-efficacy and health economy in patients undergoing obesity surgery. The aim will be investigated 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).
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
- 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
- Obesity, Pain, Postoperative
- Being tested
- Dexmedetomidine, Person-centred care (PCC), Esketamine, Lidocaine, Transcutaneous Nerve Stimulation (TENS)
- Keywords
- opioids, bariatric surgery, anesthesia, opioid-free, person-centred care, recovery, TENS, pain
- Medical subject headings
- Obesity, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
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)Behavioural
Also called Phase 2
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
EsketamineDrug
Also called Ketanest
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:
LidocaineDrug
Also called Xylocaine
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)Device
Also called TENS
The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.
RemifentanilDrug
Also called Ultiva
The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.
DesfluraneDrug
Also called Desfluran
The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia
PropofolDrug
The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
OxycodoneDrug
The control group receives Oxycodone as the routine pain management drug post-operative.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 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. Receives: Drug: Remifentanil; Drug: Desflurane; Drug: Propofol; Drug: Oxycodone |
| Intervention | Experimental | 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) Receives: Drug: Dexmedetomidine; Behavioral: Person-centred care (PCC); Drug: Esketamine; Drug: Lidocaine; Device: Transcutaneous Nerve Stimulation (TENS); Drug: Desflurane; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward.
Post-operative phase until discharge to the surgical ward. Pain assessed according to change in NRS (numeric rating scale). NRS (numeric rating scale for pain), (ranging from 0-10, "no pain" vs. "worst imagined pain").
Measured: From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward
Secondary outcomes (9)
Recovery after surgery
Investigating recovery after surgery measured with the The Post-operative Quality of Recovery Scale (PostopQRS) compared with conventional postoperative therapy.
PostopQRS: Is a validated 5-dimensional instrument (Physiology, Nociception, Emotion, Cognition, ADL) in addition to questions about patient satisfaction.
The scoring of recovery is 'return to baseline values or better' which requires a change score ≥ 0 for each question. The postoperative value for each test ( Cognition has a 2 scale tolerance due to day-to-day variation) is subtracted from the baseline value, and if no difference, then the patient is recovered.
Measured: (20 min, 40 min), during hospitalization (24 hours-72 hours) and afterwards (14 days, 30 days, three months, six months, 12 months and 24 months)
Average opioid consumption perioperative
Investigating opioid consumption during the peri- and post-operative care period compared with conventional treatment until discharge from the hospital and up to 24 months discharge.
Measured: From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge
Length of hospital stay
Length of indexed hospital stays calculated as the mean length in days from admission to discharge
Measured: Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days
Change in general Self-Efficacy
Investigating patient change in self-efficacy, measured with the General Self-Efficacy Scale (GSES). GSES is a validated questionnaire that contains 10 questions about the person's experiences of trust in his / her ability to handle difficult situations. The patient is asked to estimate his ability on a 4-point scale (1 not true) to 4 (true).
The 10 answers are summed and a mean is calculated. Higher scores are better.
Measured: 3 months, six months, 12 months, 24 months.
Change in Quality of Life
Investigating the quality of life measured with the RAND-36
RAND-36: The RAND-36 is a health-related quality of life (HRQoL) It is comprised of 36 items assessing eight areas: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Each item is scored 0-100, and are than summarized. 0 is low, 100 is the highest score to get.
Measured: (3 months, six months, 12 months, 24 months)
Exploring patient experience
Investigating patient experience and satisfaction during the hospital stay, measured with the PPE-15, a 15 item questionnaire. The PPE15 is a validated short version of The Picker Care experience survey (40 item).
Each item has response alternatives ranging from no problem, some problem, problem. Each response is coded either as "a problem" ( problem, some problem) or as "no problem". Problem is scored as=1, no problem=0. The mean is calculated both on item level and as a total score.
Measured: 2 weeks after hospital discharge
Change in health status
Investigating the change in health status measured with the EuroQol 5 dimension (EQ5D).
EQ-5D is a standardized instrument for measuring generic health status, covering five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 3 responses: no problems, some problems, and extreme problems. This response results into a number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Measured: (3 months, six months, 12 months, 24 months)
Unplanned re-admission
Investigating re-admission (un-planned) between groups.
Measured: From time of surgery up until 24 months post-surgery
Mortality
Investigating mortality rate between groups.
Measured: From time of surgery up until 24 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 May 2019
- Primary completion31 May 2028 (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 (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Prospective, randomized, non-blinded, non-commercial multi centre study. The intervention is divided into 2 phases, and 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)
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven-Egron Thörn, MD, PhD, Principal investigator, Göteborg UniversityAxel Wolf, RN, PhD, Professor, Study chair, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756961
- Sponsor's protocol ID
- OS-PCC-2017
- Other IDs
- 2017-003830-97, 2017
- Acronym
- OS-PCC
- Status last verified
- Nov 2025
- First submitted
- 22 Oct 2018
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Widarsson Norbeck D, Ohrstrom H, Lindgren S, Wolf A, Jildenstal P. Linking intraoperative nociception to postoperative pain: a secondary comparative analysis of opioid-free and opioid-based anesthesia. Scand J Pain. 2026 Mar 11;26(1). doi: 10.1515/sjpain-2025-0063. eCollection 2026 Jan 1.
PubMed 41805550Olausson 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.
PubMed 40371564
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery
- ClinicalTrials.gov ID
- NCT03756961
- Acronym / sponsor ID
- OS-PCC / OS-PCC-2017
- Conditions
- Obesity, Pain, Postoperative
- Keywords
- opioids, bariatric surgery, anesthesia, opioid-free, person-centred care, recovery, TENS, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Nov 2018 (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.
The opioid consumption has exploded in the western world, and for some patient populations such as obese patients, patients with sleep apnoea or patients undergoing cancer treatment, opioid-sparing/ opioid-free strategies could have positive effects on outcomes. Studies suggest that opioids could have opioid-induced immunosuppression, induce chronic post-operative pain syndrome and hyperalgesia in addition to the more well-known side effects such as respiratory depression, nausea, bladder, and bowel dysfunction. Hence, new studies are needed on the impact of person-centered care programs that combine pharmaceutical and non-pharmaceutical strategies to reduce the adverse short and long-term effects of opioid therapy.
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
- 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).
- Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.
- 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.
- 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).
Detailed description
Aim To evaluate the effects of opioid sparing care pathways compared to conventional opioid-based treatment for pain relief, opioid consumption, recovery after surgery, self-efficacy and health economy in patients undergoing obesity surgery. The aim will be investigated 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).
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
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, non-blinded, non-commercial multi centre study. The intervention is divided into 2 phases, and 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)
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Remifentanil, Drug: Desflurane, Drug: Propofol, Drug: OxycodoneControl 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. |
| Intervention | Experimental | Drug: Dexmedetomidine, Behavioral: Person-centred care (PCC), Drug: Esketamine, Drug: Lidocaine, Device: Transcutaneous Nerve Stimulation (TENS), Drug: Desflurane, Drug: PropofolInduction: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.
Key exclusion criteria (15 listed)
- ASA> III
- Cardiovascular disease with bradycardia (<50 bpm)
- Serious liver disease failure
- Insufficient knowledge of the Swedish language
- Serious untreated psychiatric disease
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 |
|---|---|---|
| DexmedetomidineAlso: DexdorThe 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: | Drug | Intervention |
| Person-centred care (PCC)Also: Phase 2The 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 | Behavioural | Intervention |
| EsketamineAlso: KetanestThe 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: | Drug | Intervention |
| LidocaineAlso: XylocaineThe 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. | Drug | Intervention |
| Transcutaneous Nerve Stimulation (TENS)Also: TENSThe intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge. | Device | Intervention |
| RemifentanilAlso: UltivaThe control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia. | Drug | Control |
| DesfluraneAlso: DesfluranThe patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia | Drug | Control, Intervention |
| PropofolThe patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia | Drug | Control, Intervention |
| OxycodoneThe control group receives Oxycodone as the routine pain management drug post-operative. | Drug | Control |
Primary outcome
Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward.
Time frame: From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward
Post-operative phase until discharge to the surgical ward. Pain assessed according to change in NRS (numeric rating scale). NRS (numeric rating scale for pain), (ranging from 0-10, "no pain" vs. "worst imagined pain").
9 secondary outcomes
Recovery after surgery
Time frame: (20 min, 40 min), during hospitalization (24 hours-72 hours) and afterwards (14 days, 30 days, three months, six months, 12 months and 24 months)
Average opioid consumption perioperative
Time frame: From the start of the Peri-operative phase (start of surgery) until discharge from hospital ( index stay), up to 24 months post-discharge
Length of hospital stay
Time frame: Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days
Change in general Self-Efficacy
Time frame: 3 months, six months, 12 months, 24 months.
Change in Quality of Life
Time frame: (3 months, six months, 12 months, 24 months)
Exploring patient experience
Time frame: 2 weeks after hospital discharge
Change in health status
Time frame: (3 months, six months, 12 months, 24 months)
Unplanned re-admission
Time frame: From time of surgery up until 24 months post-surgery
Mortality
Time frame: From time of surgery up until 24 months post-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 7 Jan 2026.
- Derived from this study: PubMed 41805550Widarsson Norbeck D, Ohrstrom H, Lindgren S, Wolf A, Jildenstal P. Linking intraoperative nociception to postoperative pain: a secondary comparative analysis of opioid-free and opioid-based anesthesia. Scand J Pain. 2026 Mar 11;26(1). doi: 10.1515/sjpain-2025-0063. eCollection 2026 Jan 1.
- Derived from this study: PubMed 40371564Olausson 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.
- Individual participant dataSharing planned: No
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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.
Sven-Egron Thörn, MD, PhD principal investigator
Göteborg University
Axel Wolf, RN, PhD, Professor study chair
Göteborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Person-centred care (PCC) and Esketamine in people with Obesity and Pain, Postoperative, run by Göteborg University at 2 sites in Sweden.
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 1 inclusion and 15 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 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Contact Axel Wolf, RN, PhD (+46709355364, axel.wolf@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in post-operative pain from admission to the post-anesthesia care unit (PACO) to discharge from the PACO unit to the surgical ward. (time frame: From date of randomization, difference in NRS will be assessed as the change in NRS from arrival (20 minutes after arrival) to the post-anesthesia care unit(PACU) after the surgery, to the time of discharge ( 4 hour) from the PACU to the surgical ward). 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 NCT03756961, 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 7 Jan 2026.