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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06201364
Other study ID # External oblique intercostal
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date February 1, 2024
Est. completion date August 1, 2025

Study information

Verified date January 2024
Source Assiut University
Contact Mohamed A Abd-Elkareem, MD
Phone 01050727722
Email mohamedadelkareem@aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date August 1, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary total morphine consumption first 24 hours postoperatively
Secondary Time of first rescue analgesia rescue analgesia will be given in the form of morphine 4 mg when VAS score =4 hours
Secondary 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
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