Analgesia After Laparoscopic Cholecystectomy
Comparison of Subcostal Transversus Abdominis Block With Intraperitoneal Instillation of Bupivacaine and Dexmedetomidine for Pain Relief After Laparoscopic Cholecystectomy: A Randomized Trial
1 other identifier
interventional
80
1 country
1
Brief Summary
Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started Aug 2021
Shorter than P25 for phase_2 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
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedStudy Start
First participant enrolled
August 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2022
CompletedAugust 13, 2021
August 1, 2021
6 months
January 15, 2021
August 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The intensity of postoperative pain
Assessed by the numerical rating pain scale (NRS)
24 hours after surgery
Study Arms (2)
Group I
ACTIVE COMPARATORPatients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.
Group II
PLACEBO COMPARATORPatients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Interventions
Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline
Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Eligibility Criteria
You may qualify if:
- Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.
You may not qualify if:
- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
- Altered conscious level
- Pregnancy
- Body mass index (BMI \> 35)
- Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 71515, Egypt
Related Publications (1)
El Sabour AIA, Youssef HA, Ismail EA, Ahmed DH. Comparison of subcostal transversus abdominis block with intraperitoneal instillation of bupivacaine and dexmedetomidine for pain relief after laparoscopic cholecystectomy, randomized double blinded controlled study. BMC Anesthesiol. 2025 Nov 14;25(1):560. doi: 10.1186/s12871-025-03412-4.
PMID: 41239226DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seham M Moeen, MD
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assiut University
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
August 7, 2021
Primary Completion
February 15, 2022
Study Completion
February 15, 2022
Last Updated
August 13, 2021
Record last verified: 2021-08