Clincosm LogoSign in Get a demo

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

Sponsor
Menoufia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05946733
Collaborator
(none)
48
Enrollment
1
Location
3
Arms
9.5
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Group A
  • Procedure: Group B
  • Other: Group C
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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).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).
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy
Actual Study Start Date :
Nov 26, 2022
Anticipated Primary Completion Date :
Aug 10, 2023
Anticipated Study Completion Date :
Sep 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. opioid consumption [48 hours]

    milligrams

Secondary Outcome Measures

  1. patient satisfaction [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 [1hour]

    minutes

  3. total perioperative analgesics requirements [24 hours]

    milligrams

  4. Post-operative anaesthetic care unit (PACU) stay [2 hours]

    minutes

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Menoufia University Cairo Shibin Elkom Egypt

Sponsors and Collaborators

  • Menoufia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amal Gouda Elsayed Safan, Lecturer of Anesthesiology, Intensive Care and Pain Management Faculty of Medicine - Menoufia University, Menoufia University
ClinicalTrials.gov Identifier:
NCT05946733
Other Study ID Numbers:
  • 11/2022ANET10-26
First Posted:
Jul 14, 2023
Last Update Posted:
Jul 14, 2023
Last Verified:
Jul 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 14, 2023