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

NCT05946733 | Completed

• 1 other identifier: 11/2022ANET10-26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  milligrams

  48 hours

Secondary Outcomes (4)

• patient satisfaction

  48 hours

• anesthesia recovery time

  1hour

• total perioperative analgesics requirements

  24 hours

• Post-operative anaesthetic care unit (PACU) stay

  2 hours

Study Arms (3)

Group A

EXPERIMENTAL

subcostal TAP block

Procedure: Group A

Group B

EXPERIMENTAL

lateral TAP block.

Procedure: Group B

GroupC

OTHER

will receive postoperative morphine by patient-controlled analgesia (PCA).

Other: Group C

Interventions

Group A PROCEDURE

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

Group A

Group B PROCEDURE

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)

Group B

Group C OTHER

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

GroupC

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Cairo, Shibin Elkom, Egypt

Location

Study Officials

• AMAL G SAFAN, MD

  Menoufia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Intensive Care and Pain Management Faculty of Medicine - Menoufia University

Model Details: Patients will be randomly divided into three equal groups using SPSS. Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. GroupC:will receive postoperative morphine by patient-controlled analgesia (PCA).

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 14, 2023
• Study Start: November 26, 2022
• Primary Completion: August 10, 2023
• Study Completion: January 25, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

EG (1)