Analgesic Efficacy of Transversus Abdominis Plane Block Versus External Oblique Block in Patients Undergoing Elective Laparoscopic Cholecystectomy

Postoperative pain management is a critical aspect of recovery following laparoscopic cholecystectomy, a commonly performed procedure for symptomatic gallbladder disease. Effective analgesia not only enhances patient comfort but also facilitates early mobilization, reduces the incidence of complications, and improves overall outcomes.

Oblique subcostal transversus abdominis plane block (OSTAP), one of the regional anesthesia techniques, is used in middle and upper abdominal surgeries OSTAP blocks the T6-9 intercostal nerves between the rectus abdominis and transversus abdominis muscle. Many studies have shown that OSTAP block reduces the postoperative analgesic and opioid requirement and improves the quality of postoperative pain control.

Study Overview

• Status: Not yet recruiting
• Conditions: Laparoscopic Cholecystectomy; Transversus Abdominis Plane Block; External Oblique Block
• Intervention / Treatment: Procedure: drug injected between the rectus abdominis muscle and the transversus abdominis muscle; Procedure: drug injected in the external oblique intercostal plane on both sides

Detailed Description

the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia.

Various adjuvants have been used to improve the quality and increase the duration of the local anesthetic action in different peripheral nerves and regional block techniques. dexamethasone microspheres have increased the block duration in both human and animal studies. Furthermore, dexamethasone has been shown to possess antiinflamatory action.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ghada Ghada Abo Elfadl, Asossciated professor; Phone Number: ghadafadl77@gmail.com; Email: ghadafadl77@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Faculty of medicine, Assiut University, Assiut, Egypt,
    • Contact: Ghada Abo Elfadl; Phone Number: 01005802086; Email: ghadafadl77@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients aged 18-60 years.
2. Gender: Both males and females.
3. BMI less than 35 kg/m2
4. Scheduled for laparoscopic cholecystectomy surgery
5. American Society of Anesthesiologists - ASA - I & II

Exclusion Criteria:

1-ASA physical status more than II. 2-History of allergic response to local anaesthetics or any of the medications used in the study

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAB group; 20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides	Procedure: drug injected between the rectus abdominis muscle and the transversus abdominis muscle; 20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides
Active Comparator: EOB group; 20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides	Procedure: drug injected in the external oblique intercostal plane on both sides; 20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the first analgesic request depending on Numeric Rating Scale	the first analgesic request depending on Numeric Rating Scale	24hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
• Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: November 24, 2024
• First Submitted That Met QC Criteria: November 24, 2024
• First Posted (Actual): November 27, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 04-2024-201012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No