Multimodal and Unimodal Analgesia in Cholecystectomy
Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy
1 other identifier
interventional
95
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 25, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2022
CompletedSeptember 21, 2022
September 1, 2022
1.2 years
August 25, 2022
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Type and amount of prescribed post operative non opioid analgesia
24 hour postoperative
Other Outcomes (1)
Reported opioid side effects
24 hour postoperative
Study Arms (3)
multimodal
ACTIVE COMPARATORpregabalin/ acetaminophen/ celecoxib
unimodal
ACTIVE COMPARATORPregabalin
control
NO INTERVENTIONInterventions
Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group
Acetaminophen 1 G Oral Tablet preoperative in multi-modal group
Celecoxib 400Mg Oral Capsule preoperative in multi-modal group
Eligibility Criteria
You may qualify if:
- Patients undergoing laparoscopic cholecystectomy
- Patients older than 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- October 6 Universitylead
- Beni-Suef Universitycollaborator
Study Sites (2)
Beni suef University hospital
Banī Suwayf, Egypt
Beni-Suef Hospital
Banī Suwayf, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of clinical pharmacy unit
Study Record Dates
First Submitted
August 25, 2022
First Posted
September 21, 2022
Study Start
January 1, 2019
Primary Completion
April 1, 2020
Study Completion
December 1, 2020
Last Updated
September 21, 2022
Record last verified: 2022-09