Opioid-free care for patients undergoing obesity surgery
Effects of an Opioid Sparing Care Pathway for Patients Undergoing Obesity Surgery
NA · Göteborg University · NCT03756961
This study is testing if an opioid-free way to manage pain can help people recovering from obesity surgery feel better and heal faster compared to using traditional opioid medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Göteborg University (other) |
| Locations | 2 sites (Lindesberg, Region Örebro and 1 other locations) |
| Trial ID | NCT03756961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of an opioid-free care pathway compared to traditional opioid-based treatment for pain relief in patients undergoing obesity surgery. It aims to assess pain management, recovery quality, and opioid consumption through a randomized, non-blinded, multi-centre approach. The study will utilize various interventions, including dexmedetomidine and person-centred care, to explore their impact on postoperative outcomes. The research is approved by relevant authorities and spans from November 2018 to December 2022.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for laparoscopic obesity surgery.
Not a fit: Patients with serious comorbidities, psychiatric disorders, or those currently using opioids for chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced reliance on opioids for pain management in obesity surgery patients.
How similar studies have performed: Other studies have shown promising results with opioid-sparing strategies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site. Exclusion Criteria: * 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,
Where this trial is running
Lindesberg, Region Örebro and 1 other locations
- Lindesberg Hospital — Lindesberg, Region Örebro, Sweden (RECRUITING)
- Sahlgrenska University hospital/ Östra hopsital — Gothenburg, VG, Sweden (RECRUITING)
Study contacts
- Principal investigator: Sven-Egron Thörn, MD, PhD — Göteborg University
- Study coordinator: Axel Wolf, RN, PhD
- Email: axel.wolf@gu.se
- Phone: +46709355364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Pain, Postoperative, opioids, bariatric surgery, anesthesia, opioid-free, person-centred care, recovery