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

Opioid Use Clinical Trial

— TAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05946733
• Other study ID #: 11/2022ANET10-26
• Status: Completed
• Phase: N/A
• Start date: November 26, 2022
• Est. completion date: January 25, 2024

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 25, 2024
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use

Intervention

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
• 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:
• 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

Locations

Country	Name	City	State
Egypt	Menoufia University	Cairo	Shibin Elkom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid consumption	milligrams	48 hours
Secondary	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
Secondary	anesthesia recovery time	minutes	1hour
Secondary	total perioperative analgesics requirements	milligrams	24 hours
Secondary	Post-operative anaesthetic care unit (PACU) stay	minutes	2 hours