Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy
Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study
1 other identifier
interventional
94
1 country
1
Brief Summary
Zaghiyan et al hypothesized that Laparoscopic TAP was noninferior to US-TAP and performed a randomized clinical trial comparing Laparoscopic TAP, US-TAP, and no TAP in minimally invasive colorectal surgery. The authors reported that LTAP was superior to UTAP in achieving pain control and minimizing opioid use in the first 24 hours after colorectal surgery. This prospective randomized, controlled trial will be performed to assessed the efficacy of laparoscopic subcostal TAP block (LSTAP) compared to ultrasound-guided subcostal TAP (USTAP) block after laparoscopic cholecystectomy regarding postoperative pain scores in the first 24-hours after the intervention and analgesic requirements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
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
February 17, 2020
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedAugust 20, 2020
August 1, 2020
1 year
February 17, 2020
August 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pain score
pain will be assessed with visual analogue scale from 0-10
24 hours after cholecystectomy
Secondary Outcomes (1)
Analgesic requirement
24 hours after cholecystectomy
Study Arms (3)
Laparoscopic TAP
ACTIVE COMPARATORSubcostal TAP block will be performed after surgery under laparoscopic guidance
US TAP
ACTIVE COMPARATORSubcostal TAP block will be performed after surgery under ultrasound guidance
No TAP
NO INTERVENTIONNo TAP block will be performed
Interventions
Subcostal TAP block will be performed after surgery under laparoscopic guidance
Eligibility Criteria
You may qualify if:
- Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.
You may not qualify if:
- Pregnant women
- Patients who will undergo open cholecystectomy
- Patients who will need conversion to conventional open cholecystectomy
- Patients with ASA III classification or higher
- Patients who will undergo laparoscopic cholecystectomy together with other abdominal interventions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D.
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of surgery
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 19, 2020
Study Start
February 17, 2020
Primary Completion
February 28, 2021
Study Completion
March 30, 2021
Last Updated
August 20, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share