Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Cholecystitis; Gallstone

Intervention / Treatment
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* Procedure: Laparoscopic TAP
* Procedure: US TAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic TAP<br>Subcostal TAP block will be performed after surgery under laparoscopic guidance | Procedure: Laparoscopic TAP<br>* Subcostal TAP block will be performed after surgery under laparoscopic guidance<br>|
| Active Comparator: US TAP<br>Subcostal TAP block will be performed after surgery under ultrasound guidance | Procedure: US TAP<br>* Subcostal TAP block will be performed after surgery under US guidance<br>|
| No Intervention: No TAP<br>No TAP block will be performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | pain will be assessed with visual analogue scale from 0-10 | 24 hours after cholecystectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirement | the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours | 24 hours after cholecystectomy |