Actively Recruiting
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
Led by Göteborg University · Updated on 2026-01-07
220
Participants Needed
2
Research Sites
556 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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).
CONDITIONS
Official Title
Effects of an Opioid Free/Sparing Care Pathway for Patients Undergoing Obesity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older planned to undergo laparoscopic obesity surgery (gastric bypass or sleeve surgery) at the selected site.
You will not qualify if you...
- ASA physical status classification greater than III
- Cardiovascular disease with bradycardia (heart rate less than 50 beats per minute)
- Serious liver disease or liver 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, or Lidocaine
- Presence of pacemaker or implantable cardioverter defibrillator (ICD)
- Inability to complete questionnaires
- Decline to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Lindesberg Hospital
Lindesberg, Region Örebro, Sweden, 711 82
Actively Recruiting
2
Sahlgrenska University hospital/ Östra hopsital
Gothenburg, VG, Sweden, 41678
Actively Recruiting
Research Team
A
Axel Wolf, RN, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here