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External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
external oblique intercostal plain block (EOIP)
subcostal transversus abdominis plane block (SCTAP)
control group
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Samar Rafik Amin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group E

Group T

Group C

Arm Description

patients will receive ultrasound guided external oblique intercostal plain block.

patients will receive ultrasound guided subcostal transversus abdominis plane block.

patients won't receive LA injection

Outcomes

Primary Outcome Measures

amount of postoperative morphine consumed
First postoperative analgesics request

Secondary Outcome Measures

Postoperative pain score
pain evaluated by VAS (visual analogue score).
Incidence of Postoperative nausea & vomiting (PONV)
Number of patients developing PONV
incidence of complications related to the block
agitation, dizziness, tinnitus, tremors, and numbness.

Full Information

First Posted
June 21, 2022
Last Updated
June 18, 2023
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT05432557
Brief Title
External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions
Official Title
External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 10, 2022 (Actual)
Study Completion Date
April 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group E
Arm Type
Experimental
Arm Description
patients will receive ultrasound guided external oblique intercostal plain block.
Arm Title
Group T
Arm Type
Experimental
Arm Description
patients will receive ultrasound guided subcostal transversus abdominis plane block.
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
patients won't receive LA injection
Intervention Type
Procedure
Intervention Name(s)
external oblique intercostal plain block (EOIP)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
subcostal transversus abdominis plane block (SCTAP)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control group
Intervention Description
No LA injection
Primary Outcome Measure Information:
Title
amount of postoperative morphine consumed
Time Frame
24 hours postoperatively
Title
First postoperative analgesics request
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
pain evaluated by VAS (visual analogue score).
Time Frame
at 1, 2,4 , 8, 16 and 24 hours postoperatively
Title
Incidence of Postoperative nausea & vomiting (PONV)
Description
Number of patients developing PONV
Time Frame
24 hours postoperatively
Title
incidence of complications related to the block
Description
agitation, dizziness, tinnitus, tremors, and numbness.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Samar Rafik Amin
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt

12. IPD Sharing Statement

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External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions

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