REMIFENTANIL HYDROCHLORIDE for Obesity | Postoperative pain

Inclusion criteria

• {"criterion_text":"- Patients ≥18 years planned to undergo laparoscopic obesity surgery (GBP alt Sleeve surgery) at the selected site."}
• {"criterion_text":"- Give informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- ASA> III"}
• {"criterion_text":"- Patients treated with opioids for chronic pain"}
• {"criterion_text":"- Substance abuse"}
• {"criterion_text":"- Hypersensitivity to Oxycodone, Esketamine, Dexmedetomidine, and Lidocaine"}
• {"criterion_text":"- Pacemaker or ICD"}
• {"criterion_text":"- Inability to fill in questionnaires"}
• {"criterion_text":"- Decline participation"}
• {"criterion_text":"- Cardiovascular disease with bradycardia (<50 bpm)"}
• {"criterion_text":"- Serious liver disease failure"}
• {"criterion_text":"- Insufficient knowledge of the Swedish language"}
• {"criterion_text":"- Serious untreated psychiatric disease"}
• {"criterion_text":"- Neurocognitive dysfunction"}
• {"criterion_text":"- Pregnancy"}
• {"criterion_text":"- Women of childbearing age without contraception"}
• {"criterion_text":"- Malignant disease with expected short survival"}

Primary endpoints

• {"endpoint_text":"- No difference in patient-reported pain score according to NRS (Numeric Rating Scale, 0-10), calculated as a deviation of one scale step within the NRS scale, between the intervention group patients compared to conventional treatment (control group) postoperatively. NRS (numeric rating scale for pain) during the last 24 hours (scale 0-10, 'no pain' vs. 'worst imaginable pain').","definition_or_measurement_approach":"Patient-reported Numeric Rating Scale (NRS) 0-10 during the last 24 hours; primary comparison is deviation of one scale step within the NRS between intervention and control postoperatively."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite score including Self-Efficacy measure, PQRS, hospital readmission, or death at 3 months."}
• {"endpoint_text":"- An opioid-sparing treatment results in reduced opioid consumption during the peri- and postoperative period until discharge to the ward compared to conventional treatment.","definition_or_measurement_approach":"Measured opioid consumption during peri- and postoperative period until discharge to ward (quantitative opioid use)."}
• {"endpoint_text":"- An opioid-sparing treatment results in reduced opioid consumption throughout the hospital stay compared to conventional treatment.","definition_or_measurement_approach":"Measured total opioid consumption during the entire hospital stay."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported NRS at 3 months and 6 months postoperatively."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Postoperative Quality of Recovery Scale (PQRS) assessed at specified time points (20, 40 minutes; 24-72 hours; 14 days; 30 days; 3, 6, 12, 24 months)."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"General Self-Efficacy Scale scores at 3, 6, 12 and 24 months."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Quality of life measured by RAND-36 and EQ5D at 3, 6, 12 and 24 months."}
• {"endpoint_text":"- An opioid-sparing treatment results in equivalent length of hospital stay compared to conventional treatment during the in-hospital period.","definition_or_measurement_approach":"Length of hospital stay comparison during in-hospital period."}
• {"endpoint_text":"- Mapping of long-term prescription of analgesic drugs. Does an opioid-sparing treatment impact the long-term use of analgesic medications.","definition_or_measurement_approach":"Assessment/mapping of long-term analgesic prescriptions postoperatively."}
• {"endpoint_text":"- Cost-minimization analysis/cost effectiveness analysis from a healthcare perspective. Micro-costing assessment of perioperative and surgery ward resource use, including healthcare consumption up to 6 months postoperatively.","definition_or_measurement_approach":"Health-economic analysis including micro-costing of perioperative and ward resource use and healthcare consumption up to 6 months."}

Sweden

Earliest CTIS Part Ii Submission Date

28-09-2023

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

900

Number Of Sites

2

Number Of Participants

220

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden