Multimodal and Unimodal Analgesia in Cholecystectomy

Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy

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

Study Overview

• Status: Completed
• Conditions: Compare Unimodal and Multimodal Analgesics
• Intervention / Treatment: Drug: Pregabalin 150mg; Drug: Acetaminophen 1 G Oral Tablet; Drug: Celecoxib 400Mg Oral Capsule

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Beni Suef University Hospital
  • Banī Suwayf, Egypt
    • Beni-Suef Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: control
ACTIVE_COMPARATOR: multimodal; pregabalin/ acetaminophen/ celecoxib	Drug: Pregabalin 150mg; Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group; Drug: Acetaminophen 1 G Oral Tablet; Acetaminophen 1 G Oral Tablet preoperative in multi-modal group; Drug: Celecoxib 400Mg Oral Capsule; Celecoxib 400Mg Oral Capsule preoperative in multi-modal group
ACTIVE_COMPARATOR: unimodal; Pregabalin	Drug: Pregabalin 150mg; Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and amount of prescribed post operative non opioid analgesia	Type and amount of prescribed post operative non opioid analgesia	24 hour postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reported opioid side effects	Side effects reported after opioid administration eg. nausea, vomiting, respiratory depression etc..	24 hour postoperative

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): December 1, 2020

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (ACTUAL): September 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Cyclooxygenase 2 Inhibitors; Calcium Channel Blockers; Celecoxib; Acetaminophen; Pregabalin
• Other Study ID Numbers: FWA00015574

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No