Comparison Between External Oblique Intercostal Plane Block and the Transversus Abdominis Plane Block in Paraumbilical Hernia Repair as Analgesia for Intraoperative and Postoperative Pain.

May 15, 2024 updated by: Mohamed Gamal Hassan Rashwan, Assiut University

AIM OF STUDY:

Comparison between effect of external oblique intercostal plane block and the Oblique subcostal transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

A paraumbilical hernia is a hole in the connective tissue of the abdominal wall in the midline with close approximation to the umbilicus. If the hole is large enough there can be protrusion of the abdominal contents, including omental fat and/or bowel. These defects are usually congenital and are not noticed until they slowly enlarge over an individual's life time and abdominal contents herniate through the hole creating either pain or a visible lump on the abdominal wall. If abdominal contents get incarcerated (or stuck) in the hole this can cause pain. If the abdominal contents become strangulated by losing their blood supply from pinching or twisting those tissue will die. If it is omental fat this will cause pain and could potentially lead to an infection. If the strangulated contents are bowel then in addition to pain the individual will develop a bowel obstruction. And if the dead bowel is not surgically removed in an emergent fashion the condition could be fatal.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism and respiratory complications and prolongs the hospital stay. This pain is routinely managed using opiates, which are associated with several side effects, including excessive sedation and postoperative nausea and vomiting (PONV) which may increase hospital stay durations. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

the subcostal transversus abdominis plane block (TAP) targets the upper abdominal wall.

The EOI block represents an important modification that cover the upper lateral abdominal wall.

Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall,specifically from T6 to L1. The OSCTAP has been described that can be performed to provide analgesia for abdominal surgery extending above the umbilicus.

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
  2. patients with the American Society of Anesthesiologists (ASA) physical status I/II
  3. Patients scheduled for elective paraumbilical hernia

Exclusion Criteria:

  • 1-Known hypersensitivity to the study drugs. 2-Body Mass Index > 40 kg/m2. 3- Inability to accurately describe postoperative pain to investigators. 4-Opioid tolerance or dependence. 5-Preexisting history of chronic pain. 6-History of renal, liver, cardiac, neuropsychiatric disorder problems. 7-Bleeding or coagulation abnormality. 8-Patients who received any analgesic 24 h before surgery 9-Patients who have difficulty understanding the study protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transversus abdominis plane (TAP) block
Group A will include 31 patients to receive TAP block with 20 ml volume on each side (0.25 % bupivacaine)
Procedure: Transversus abdominis plane (TAP) block

TAP block technique:

abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest (18) . Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. and ingect 20 ml volume of (0.25 % bupivacaine). If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.
Active Comparator: External Oblique intercostal (EOI) block
Group B will include 31 patients to receive EOI block with 20 ml volume on each side ( 0.25% bupivacaine)
Procedure: External Oblique Intercostal (EOI) block
EOI block technique A linear ultrasound transducer placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, The transducer was then rotated so the cranial end was directed slightly medially and the caudal end laterally to produce a paramedian sagittal oblique view with a short-axis view of the ribs, The following structures were identified, from superficial to deep: subcutaneous tissue, external oblique muscle, intercostal muscles between ribs, pleura, and lung. The skin entry point for the injection was cranial to the sixth rib level just medial to the anterior axillary line, with ultrasound opaque needle advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle hydrodissecting the tissue plane between the sixth and seventh ribs, and then the needle was directed caudally toward the eighth rib. and inject 20 ml volume of (0.25 % bupivacaine).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect between external oblique intercostal plane block and the transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain according to numeric rating score (NRS)
Time Frame: baseline

numeric rating scale : from 0 to 10 0 : no pain

1 - 3 : mild pain 4 - 6 : moderate pain 7 - 9 : severe pain 10 : worst pain possible
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of the first opioid request
Time Frame: baseline
time of the first opioid request all over 24 hours postoperatively.
baseline
Heart rate
Time Frame: baseline
heart rate will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
baseline
Mean arterial blood pressure
Time Frame: baseline
mean arterial blood pressure will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.
baseline
time to start ambulation
Time Frame: baseline
time of the patient first movement will be recorded
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

December 29, 2026

Study Registration Dates

First Submitted

February 23, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • paraumbilical hernia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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