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Clinical Trials/NCT04276285
NCT04276285UnknownNot Applicable

Impact of Laparoscopic Versus Ultrasound-Guided Subcostal Transversus Abdominis Plane Block on Pain and Recovery After Laparoscopic Cholecystectomy: A Randomized Double-Blinded Controlled Study

Mansoura University1 site in 1 country94 target enrollmentStarted: February 17, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
94
Locations
1
Primary Endpoint
Pain score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Consecutive adult patients of either gender who will undergo laparoscopic cholecystectomy will be recruited to the study.

Exclusion Criteria

  • •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.

Arms & Interventions

Laparoscopic TAP

Active Comparator

Subcostal TAP block will be performed after surgery under laparoscopic guidance

Intervention: Laparoscopic TAP (Procedure)

US TAP

Active Comparator

Subcostal TAP block will be performed after surgery under ultrasound guidance

Intervention: US TAP (Procedure)

No TAP

No Intervention

No TAP block will be performed

Outcomes

Primary Outcomes

Pain score

Time Frame: 24 hours after cholecystectomy

pain will be assessed with visual analogue scale from 0-10

Secondary Outcomes

  • Analgesic requirement(24 hours after cholecystectomy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sameh Emile

lecturer of surgery

Mansoura University

Study Sites (1)

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