Laparoscopic Versus US-Guided Subcostal TAP Block After Laparoscopic Cholecystectomy

Cholecystitis; Gallstone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04276285
• Other study ID #: Mansoura124
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: August 2020
• Source: Mansoura University
• Contact: Sameh H Emile, M.D.
• Phone: +201006267150
• Email: sameh200[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: March 30, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis; Gallstone
• Gallstones

Intervention

Procedure:
• Laparoscopic TAP
Subcostal TAP block will be performed after surgery under laparoscopic guidance
• US TAP
Subcostal TAP block will be performed after surgery under US guidance

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	pain will be assessed with visual analogue scale from 0-10	24 hours after cholecystectomy
Secondary	Analgesic requirement	the need for intravenous analgesia after surgery calculated as the cumulative dose of analgesic administered over 24 hours	24 hours after cholecystectomy