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Clinical Trials/NCT05547659
NCT05547659
Completed
Phase 1

Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy

October 6 University2 sites in 1 country95 target enrollmentJanuary 1, 2019

Overview

Phase
Phase 1
Intervention
Pregabalin 150mg
Conditions
Compare Unimodal and Multimodal Analgesics
Sponsor
October 6 University
Enrollment
95
Locations
2
Primary Endpoint
Postoperative visual analogue scale (VAS)
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

engy wahsh

head of clinical pharmacy unit

October 6 University

Eligibility Criteria

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

Arms & Interventions

multimodal

pregabalin/ acetaminophen/ celecoxib

Intervention: Pregabalin 150mg

multimodal

pregabalin/ acetaminophen/ celecoxib

Intervention: Acetaminophen 1 G Oral Tablet

multimodal

pregabalin/ acetaminophen/ celecoxib

Intervention: Celecoxib 400Mg Oral Capsule

unimodal

Pregabalin

Intervention: Pregabalin 150mg

Outcomes

Primary Outcomes

Postoperative visual analogue scale (VAS)

Time Frame: 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

Time Frame: 24 hour postoperative

ampules of opioid analgesia needed after operation

Secondary Outcomes

  • Type and amount of prescribed post operative non opioid analgesia(24 hour postoperative)

Study Sites (2)

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