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

NCT06707324 | Not Yet Recruiting DMC

• 1 other identifier: 04-2024-201012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transversus Abdominis Plane Block; External Oblique Block; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• the first analgesic request depending on Numeric Rating Scale

  the first analgesic request depending on Numeric Rating Scale

  24hours

Study Arms (2)

TAB group

ACTIVE COMPARATOR

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

EOB group

ACTIVE COMPARATOR

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

Interventions

drug injected between the rectus abdominis muscle and the transversus abdominis muscle PROCEDURE

20 ml of 0.25% bupivacaine + 8 mg dexamethasone between the rectus abdominis muscle and the transversus abdominis muscle on both sides

TAB group

drug injected in the external oblique intercostal plane on both sides PROCEDURE

20 ml of 0.25% bupivacaine+ 8 mg dexamethasone into the external oblique intercostal plane on both sides

EOB group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of medicine, Assiut University, Assiut, Egypt,

Asyut, 71515, Egypt

Location

Related Publications (2)

• 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.

  PMID: 34626112 RESULT

• 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.

  PMID: 34422893 RESULT

Central Study Contacts

Ghada Ghada Abo Elfadl, Asossciated professor

CONTACT

ghadafadl77@gmail.com; ghadafadl77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: November 27, 2024
• Study Start: December 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 15, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

EG (1)