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Completed

NCT Number: NCT05946733

Two Approaches of Transversus Abdominis Block (TAP ) in 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

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Key information

Conditions

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University

Cairo, Shibin Elkom, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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

Primary outcomes

  1. opioid consumption

    Time frame: 48 hours

    milligrams

Secondary outcomes

  1. patient satisfaction

    Time frame: 48 hours

    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)

  2. anesthesia recovery time

    Time frame: 1hour

    minutes

  3. total perioperative analgesics requirements

    Time frame: 24 hours

    milligrams

  4. Post-operative anaesthetic care unit (PACU) stay

    Time frame: 2 hours

    minutes

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Acronym: TAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 14, 2023
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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