Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy
Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy
1 other identifier
interventional
100
1 country
1
Brief Summary
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable postoperative-pain
Started Jun 2024
Shorter than P25 for not_applicable postoperative-pain
1 active site
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
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 11, 2025
July 1, 2024
5 months
July 25, 2024
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
incidence and severity of postoperative pain for 24 hours
using VAS pain score
severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale
Study Arms (2)
bupivacaine with dexamethasone
ACTIVE COMPARATOR40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).
bupivacaine with dexmedetomidine
ACTIVE COMPARATOR40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).
Interventions
intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).
intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).
Eligibility Criteria
You may qualify if:
- Patients scheduled for laparoscopic cholecystectomy
- Age 18-60 years
- American Society of Anesthesiologists (ASA) physical status I-II
You may not qualify if:
- Patients with diabetes mellitus
- Allergy to the study drugs
- Patients on steroids
- Pregnant females
- Patients with cardiac, pulmonary, hepatic or renal disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zaher
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
July 25, 2024
First Posted
August 2, 2024
Study Start
June 1, 2024
Primary Completion
November 10, 2024
Study Completion
December 1, 2024
Last Updated
March 11, 2025
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share