Do injections with a local anesthesia in laparoscopic gastric bypass surgery reduce postoperative pain and use of opioids?

Phase 1

• Conditions: Postoperative pain; MedDRA version: 16.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; MedDRA version: 16.0Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2012-002618-38-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-25
• Study Completion: 2015-10-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Patients > 18 years old
- Planned primary laparoscopic gastric bypass surgery
- BMI > 35
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- No informed consent possible or obtained
- Bariatric surgery or major abdominal surgeries in the past
- Known side effects or allergies to morfine or bupivacaine
- Use of opioids or benzodiazepines in the past 3 months
- History of alcohol- or drugabuse
- Indication for premedication with a benzodiazepine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To evaluate side-effects from opioids, mobilisation, length of hospitalstay and patientsatisfaction with pain treatment. Our hypothosis is that in our treatment group we will less side-effect from opioids. We expect to see that mobilisation within two hours after surgery will be possible for more patients in our treatment group, length of hospitalstay will be shorter and patientsatisfaction with pain treatment will improve. ;Main Objective: To evaluate the postoperative opioid consumption and pain after laparoscopic bariatric surgery. Our hypothesis is that less opioids will be consumed by patients in the group receiving local anesthetics compared to normal saline. ;Primary end point(s): Pain<br>Opioid consumption;Timepoint(s) of evaluation of this end point: Directly after surgery at 10, 20 and 30minutes after arrival at the recovery room.<br>At 6, 12, 18 and 24 hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Side effects<br>Hospital stay<br>Mobilisation within 2 hours yes or no<br>Patientsatisfaction;Timepoint(s) of evaluation of this end point: Side effects:<br>Directly after surgery at 10, 20 and 30minutes after arrival at the recovery room.<br>At 6, 12, 18 and 24 hours after surgery.<br><br>Mobilisation: 2 hours after surgery<br><br>Patientsatisfaction: 24 hours after surgery<br><br>Hospitalstay: a few days after surgery, depending on when the patient leaves the hospital