Multimodal and Unimodal Analgesia in Cholecystectomy

Phase 1

Completed

• Conditions: Compare Unimodal and Multimodal Analgesics
• Interventions: Drug: Pregabalin 150mg; Drug: Acetaminophen 1 G Oral Tablet; Drug: Celecoxib 400Mg Oral Capsule

• Registration Number: NCT05547659
• Lead Sponsor: October 6 University

Brief Summary

Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-12-01
• Study First Submitted: 2022-08-25
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Patients undergoing laparoscopic cholecystectomy
• Patients older than 18 years old

Exclusion Criteria

• Renal or hepatic or cardiac impairment patients
• Patients with chronic pain history
• Allergic patients after taking aspirin or other NSAIDs
• patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multimodal	Pregabalin 150mg	pregabalin/ acetaminophen/ celecoxib
multimodal	Acetaminophen 1 G Oral Tablet	pregabalin/ acetaminophen/ celecoxib
multimodal	Celecoxib 400Mg Oral Capsule	pregabalin/ acetaminophen/ celecoxib
unimodal	Pregabalin 150mg	Pregabalin

Primary Outcome Measures

Name	Time	Method
Postoperative visual analogue scale (VAS)	24 hour postoperative	The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.
Amount of post operative Needed opioid analgesia	24 hour postoperative	ampules of opioid analgesia needed after operation

Secondary Outcome Measures

Name	Time	Method
Type and amount of prescribed post operative non opioid analgesia	24 hour postoperative	Type and amount of prescribed post operative non opioid analgesia

Trial Locations

Locations (2)

Beni suef University hospital; 🇪🇬 Banī Suwayf, Egypt

Beni-Suef Hospital; 🇪🇬 Banī Suwayf, Egypt