The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. The participants will be divided into 2 groups: with or without preemptive pregabalin administration.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities
• Written informed consent
Locations
Other Locations
Poland
Szpital Kliniczny Dzieciatka Jezus
RECRUITING
Warsaw
Contact Information
Primary
Piotr Mieszczański, MD
piotr.mieszczanski@gmail.com
669643205
Time Frame
Start Date: 2023-04-24
Estimated Completion Date: 2025-08-01
Participants
Target number of participants: 90
Treatments
Placebo_comparator: Multimodal analgesia group
Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.
Experimental: Multimodal analgesia with preemptive pregabalin group
Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Warsaw