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

Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy; Erector Spinae Plane Block; Ultrasound; Oblique Subcostal Transversus Abdominis Plane Block
• Intervention / Treatment: Other: Erector spinae plane block; Other: Oblique subcostal transversus abdominis plane block

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Helwan, Cairo, Egypt, 11795
      • Helwan university

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae plane block group; Patients received ultrasound-guided erector spinae plane block.	Other: Erector spinae plane block; Patients received ultrasound-guided erector spinae plane block.
Experimental: Oblique subcostal transversus abdominis plane block group; Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.	Other: Oblique subcostal transversus abdominis plane block; Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pain intensity	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.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	Time to first rescue analgesia was assessed from the end of surgery to the first dose of morphine administrated	24 hours postoperatively
Total amount of morphine consumption	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.	24 hours postoperatively
Morphine-related side effects	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.	24 hours postoperatively
Local anesthetics-related side effects	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.	24 hours postoperatively
Incidence of adverse effects of the block technique	Signs of adverse effects of the block techniques, such as local site infection, hematoma formation, bowel perforation, or pneumothorax, were recorded.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 118-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No