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Not yet recruiting NCT06707324

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

No phase Interventional Transversus Abdominis Plane Block External Oblique Block Laparoscopic Cholecystectomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: drug injected between the rectus abdominis muscle and the transversus abdominis muscle, drug injected in the external oblique intercostal plane on both sides.
Who it may be relevant to
Registry conditions: Transversus Abdominis Plane Block, External Oblique Block, Laparoscopic Cholecystectomy. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • the first analgesic request depending on Numeric Rating Scale [Time frame: 24hours]

Eligibility criteria

Inclusion criteria

  • 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

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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of medicine, Assiut University, Assiut, Egypt, — Asyut

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. PMID 34626112
  • 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

Identifiers

NCT: NCT06707324 · 04-2024-201012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗