External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients

To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: The external oblique intercostal block; Procedure: Paravertebral block

Detailed Description

Paravertebral Block (PVB) involve injection of local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.

The external oblique intercostal block is a novel motor- and opioid-sparing technique which blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves which innervate the upper abdominal quadrant.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mohamed A Abd-Elkareem, MD; Phone Number: 01050727722; Email: mohamedadelkareem@aun.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients between 20-60 years old
• Patients with ASA clinical status I\II
• Patients schedule for laparoscopic cholecystectomy

Exclusion Criteria:

• Patients refusal
• Coagulopathy
• Infection at site of injection
• Allergy of local anesthesia
• Sever cardiac disease
• Patients with chest wall deformities

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
Experimental: EOI group; chest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally.	Procedure: The external oblique intercostal block; chest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine, 10 ml saline) will be injected under ultrasound guidance and this will be done bilaterally.
Active Comparator: PVB group; we will be scanning the anatomy of the lateral paravertebral space using a high-frequency linear ultrasound transducer, after identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique would be used to perform the PVB with 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally.	Procedure: Paravertebral block; involve injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total morphine consumption	first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first rescue analgesia	rescue analgesia will be given in the form of morphine 4 mg when VAS score ≥4	hours
Visual analogue scale (VAS)	It is a validated subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."	at 0.5 ,1,2,4,8,12,24 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: External oblique intercostal

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