Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Ultrasound; Erector Spinae Plane Block; Oblique Subcostal Transversus Abdominis Plane Block; Laparoscopic Cholecystectomy

• Registration Number: NCT06640062
• Lead Sponsor: Helwan University

Brief Summary

The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.

Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.

Study Timeline

• Study Start: 2023-01-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age from 20 to 60 years.
• Both gender.
• American Society of Anesthesiologists (ASA) grade I and II physical status.
• Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
• Underwent laparoscopic cholecystectomy.

Exclusion Criteria

• Patient refusal.
• Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
• History of psychological disorders and/or chronic pain syndrome.
• Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
• Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
• Severe cardiac disorders such as (heart failure).
• Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
• Advanced kidney disease (Decreased creatinine clearance <40 ml/min).
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of pain intensity	24 hours postoperatively	The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Total amount of morphine consumption	24 hours postoperatively	When a patient complains of pain equivalent to the Visual Analogue Scale (VAS) ≥ 3, rescue analgesia is given in the form of morphine (0.05mg/kg) intravenous increments, as needed.
Incidence of adverse effects of the block technique	24 hours postoperatively	Signs of adverse effects of the block techniques, such as local site infection, hematoma formation, bowel perforation, or pneumothorax, were recorded.
Time to first rescue analgesia	24 hours postoperatively	Time to first rescue analgesia was assessed from the end of surgery to the first dose of morphine administrated
Morphine-related side effects	24 hours postoperatively	Morphine-related side effects such as incidence of nausea and vomiting, respiratory depression (respiratory rate \< 8 breaths/min), bradycardia (heart rate decreases by \> 20% of basal reading), pruritus, and urine retention were recorded.
Local anesthetics-related side effects	24 hours postoperatively	Local anesthetics-related side effects such as lightheadedness, circumoral numbness, tongue paresthesia, drowsiness, irritability, muscle twitches, convulsions, bradycardia, hypotension (mean arterial blood pressure decreases by \> 20% of basal reading), hypoventilation and cardiac arrest were recorded.

Trial Locations

Locations (1)

Helwan University; 🇪🇬 Helwan, Cairo, Egypt