Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy (TAP)

Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy

the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Procedure: Group A; Procedure: Group B; Other: Group C

Detailed Description

General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane

During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.

Patients will be randomly divided into three equal groups:

Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sondos Mokhtar Nassar, M.B.,B.C; Phone Number: 02 01020113426; Email: sondosnassar945@gmail.com
• Study Contact Backup: Name: Amal Gouda Safan, MD; Phone Number: 02 01027386221; Email: AMAL.GODA52@med.menofia.edu.eg

Study Locations

• Egypt
  • Shibin Elkom
    • Cairo, Shibin Elkom, Egypt
      • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Eligible patients will be older than 21 years old with American society of anaesthesia physical status I& II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

• - Uncooperative.
• Patients who have allergy to any of the study drugs.
• Patients who are on opioids.
• Known abuse of alcohol or medication.
• Local infection at the site of injection or systemic infection.
• Pregnancy.
• Patients with coagulation disorders or on anticoagulation therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; subcostal TAP block	Procedure: Group A; After induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer
Experimental: Group B; lateral TAP block.	Procedure: Group B; After induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz)
Other: GroupC; will receive postoperative morphine by patient-controlled analgesia (PCA).	Other: Group C; the analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	milligrams	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	visual analogue scale ((a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)	48 hours
anesthesia recovery time	minutes	1hour
total perioperative analgesics requirements	milligrams	24 hours
Post-operative anaesthetic care unit (PACU) stay	minutes	2 hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Director: AMAL G SAFAN, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2022
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): January 25, 2024

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 11/2022ANET10-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No