Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery

NCT03756961 | Recruiting DMC

• 2 other identifiers: OS-PCC-20172017-003830-97
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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. 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

1. 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. 2.Describe the clinical monitoring trend regarding nociceptive response intraoperatively between opioid-free and conventional care.
3. 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. 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.

Conditions

Obesity; Pain, Postoperative

Keywords

opioids; bariatric surgery; anesthesia; opioid-free; person-centred care; recovery; TENS; pain

Outcome Measures

Primary Outcomes (1)

• 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").

  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

  (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

  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

  Indexed length of hospital day will be calculated in days/hours). Estimated stay is 2 days

• Change in general Self-Efficacy

  3 months, six months, 12 months, 24 months.

• Change in Quality of Life

  (3 months, six months, 12 months, 24 months)

Other Outcomes (1)

• Economic evaluation

  During hospital stay and up to 24 months

Study Arms (2)

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.

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)

Drug: Dexmedetomidine; Behavioral: Person-centred care (PCC); Drug: Esketamine; Drug: Lidocaine; Device: Transcutaneous Nerve Stimulation (TENS); Drug: Desflurane; Drug: Propofol

Interventions

Dexmedetomidine DRUG

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:

Also known as: Dexdor

Intervention

Person-centred care (PCC) BEHAVIORAL

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

Also known as: Phase 2

Intervention

Esketamine DRUG

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:

Also known as: Ketanest

Intervention

Lidocaine DRUG

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.

Also known as: Xylocaine

Intervention

Transcutaneous Nerve Stimulation (TENS) DEVICE

The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.

Also known as: TENS

Intervention

Remifentanil DRUG

The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.

Also known as: Ultiva

Control

Desflurane DRUG

The patient receives general anesthesia with Desflurane/ or Sevoflurane as the routine volatile anesthetic during general anesthesia

Also known as: Desfluran

Control; Intervention

Propofol DRUG

The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia

Control; Intervention

Oxycodone DRUG

The control group receives Oxycodone as the routine pain management drug post-operative.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site.

You may not qualify if:

• ASA\> III
• 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,

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (2)

Lindesberg Hospital

Lindesberg, Region Örebro, 711 82, Sweden

RECRUITING

Sahlgrenska University hospital/ Östra hopsital

Gothenburg, VG, 41678, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 41805550 DERIVED

• 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.

  PMID: 40371564 DERIVED

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Pain

Interventions

Dexmedetomidine; Clinical Trials, Phase II as Topic; Esketamine; Ketamine; Lidocaine; Transcutaneous Electric Nerve Stimulation; Remifentanil; Desflurane; Propofol; Oxycodone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Sven-Egron Thörn, MD, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Axel Wolf, RN, PhD, Professor

  Göteborg University

  STUDY CHAIR

Central Study Contacts

Axel Wolf, RN, PhD

CONTACT

+46709355364; axel.wolf@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 28, 2018
• Study Start: May 1, 2019
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)