Multimodal and Unimodal Analgesia in Cholecystectomy

• Sponsor: October 6 University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05547659
• Collaborator: Beni-Suef University (Other)
• Enrollment: 95
• Locations: 2
• Arms: 3
• Actual Duration (Months): 23
• Patients Per Site: 47.5
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Compare Unimodal and Multimodal Analgesics	Drug: Pregabalin 150mg; Drug: Acetaminophen 1 G Oral Tablet; Drug: Celecoxib 400Mg Oral Capsule	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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
No Intervention: control

Outcome Measures

Primary Outcome Measures

1. 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.

2. Amount of post operative Needed opioid analgesia [24 hour postoperative]

   ampules of opioid analgesia needed after operation

Secondary Outcome Measures

1. Type and amount of prescribed post operative non opioid analgesia [24 hour postoperative]

   Type and amount of prescribed post operative non opioid analgesia

Other Outcome Measures

1. Reported opioid side effects [24 hour postoperative]

   Side effects reported after opioid administration eg. nausea, vomiting, respiratory depression etc..

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni suef University hospital	Banī Suwayf		Egypt
2	Beni-Suef Hospital	Banī Suwayf		Egypt

Sponsors and Collaborators

• October 6 University
• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: engy wahsh, head of clinical pharmacy unit, October 6 University
• ClinicalTrials.gov Identifier: NCT05547659
• Other Study ID Numbers: FWA00015574
• First Posted: Sep 21, 2022
• Last Update Posted: Sep 21, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acetaminophen; Celecoxib; Pregabalin

Study Results

No Results Posted as of Sep 21, 2022