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

NCT06201364 | Unknown Phase 3

• 1 other identifier: External oblique intercostal
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• total morphine consumption

  first 24 hours postoperatively

Secondary Outcomes (2)

• Time of first rescue analgesia

  hours

• Visual analogue scale (VAS)

  at 0.5 ,1,2,4,8,12,24 hours postoperatively

Study Arms (2)

EOI group

EXPERIMENTAL

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

PVB group

ACTIVE COMPARATOR

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

Interventions

The external oblique intercostal block PROCEDURE

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.

EOI group

Paravertebral block PROCEDURE

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.

PVB group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Mohamed A Abd-Elkareem, MD

CONTACT

01050727722; mohamedadelkareem@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: January 11, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: August 1, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01