- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05432557
External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions
External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial
Various newer techniques have been proposed to enhance analgesia in upper abdominal region. The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions than the traditional transverse abdominis plane block.
The External oblique intercostal plane (EOIP) block is a novel technique reported by Hamilton et al. performed EOPB by administering LA superior or deep of the external oblique muscle from the sixth intercostal space leading to the blockage of thoracoabdominal nerves at T6-T10. It has several attractive aspects such as easy sono-anatomy ribs one strip of muscle so easy to demonstrate even in obese patients, there is a bony backstop, easy expandable fascial plane that can accommodate a catheter and it is shallow block with no big vessels nearby.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Qalubia
-
Banhā, Qalubia, Egypt, 13511
- Samar Rafik Amin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status grade I -II,
- Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy- open cholecystectomy- nephrectomy).
Exclusion Criteria:
- Allergy to local anesthetics,
- Infection at the site of injection,
- Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
- Patients who received any analgesic 24 h before surgery.
- Chronic liver disease, chronic renal disease, and cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group E
patients will receive ultrasound guided external oblique intercostal plain block.
|
A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation at the sixth intercostal space in the anterior midaxillary line.
A 21G 10 cm needle will be inserted using an in plane approach.
The tip of the needle will be placed into the fascial plane on the deep aspect of the external oblique muscle.
A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected.
|
Experimental: Group T
patients will receive ultrasound guided subcostal transversus abdominis plane block.
|
The US probe will be placed immediately below the costal margin on oblique plane toward the lateral close to midline to identify the rectus abdominis muscle.
The transversus abdominis muscle will be identified lying posterior to the rectus muscle.
An 8cm 22-gauge block needle will be inserted using an in- plane approach.
transversus abdominis plane will be accessed by placing the needle adjacent to costal margin but medial to linea semilunaris.
The needle will be advanced slowly in-plane to promote hydrodissection along the oblique subcostal line.
A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected.
|
Placebo Comparator: Group C
patients won't receive LA injection
|
No LA injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
amount of postoperative morphine consumed
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
First postoperative analgesics request
Time Frame: 24 hours postoperatively
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative pain score
Time Frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively
|
pain evaluated by VAS (visual analogue score).
|
at 1, 2,4 , 8, 16 and 24 hours postoperatively
|
Incidence of Postoperative nausea & vomiting (PONV)
Time Frame: 24 hours postoperatively
|
Number of patients developing PONV
|
24 hours postoperatively
|
incidence of complications related to the block
Time Frame: 24 hours postoperatively
|
agitation, dizziness, tinnitus, tremors, and numbness.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC 1-5-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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