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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05432557
Other study ID # RC 1-5-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 20, 2022
Est. completion date April 20, 2023

Study information

Verified date June 2023
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 20, 2023
Est. primary completion date December 10, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status grade I -II, 2. Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy- open cholecystectomy- nephrectomy). Exclusion Criteria: 1. Allergy to local anesthetics, 2. Infection at the site of injection, 3. Coagulopathy, 4. Chronic pain syndromes, 5. Prolonged opioid medication, 6. Patients who received any analgesic 24 h before surgery. 7. Chronic liver disease, chronic renal disease, and cognitive impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
external oblique intercostal plain block (EOIP)
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.
subcostal transversus abdominis plane block (SCTAP)
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.
Other:
control group
No LA injection

Locations

Country Name City State
Egypt Samar Rafik Amin Banha Qalubia

Sponsors (1)

Lead Sponsor Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary amount of postoperative morphine consumed 24 hours postoperatively
Primary First postoperative analgesics request 24 hours postoperatively
Secondary Postoperative pain score pain evaluated by VAS (visual analogue score). at 1, 2,4 , 8, 16 and 24 hours postoperatively
Secondary Incidence of Postoperative nausea & vomiting (PONV) Number of patients developing PONV 24 hours postoperatively
Secondary incidence of complications related to the block agitation, dizziness, tinnitus, tremors, and numbness. 24 hours postoperatively
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