Bilateral External Oblique Intercostal Plane Block in Post Operative Pain Management in Hepatectomy (EOI)

February 11, 2025 updated by: Sherif Alaa Embaby

Bilateral External Oblique Intercostal Plane Block Versus Patient Controlled Analgesia (PCA) in Post Operative Pain Management in Hepatectomy Surgery.

The majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Although epidural catheters are efficient to provide perioperative analgesia, in this type of surgery patients may be more susceptible to catheter related complications due to the alteration in coagulation parameters. That is why safer alternatives are sought for those patients. The use of patient-controlled analgesia (PCA) for postoperative pain management improves patients' quality of recovery. However, there are many concerns regarding the type of opioids used in PCA such as overdosing, underdosing, and the effect of the hepatectomy on the drug metabolism in those patients. External oblique intercostal plane block (EOI block) is a relatively novel block used in upper abdominal incisions especially subcostal laparotomy to provide intraoperative and postoperative analgesia.

This study aims to compare the efficacy of Bilateral External Oblique Intercostal Plain Block versus PCA in pain management and reduction of opioid use in hepatectomy surgery done by subcostal incision.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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:

  • Age ≥ 18 and ≤ 65 Years.
  • Both sexes.
  • Patients will be scheduled for hepatectomy surgery.
  • Body mass index (BMI) 18.5-30.0 /m 2 .

Exclusion Criteria:

  • Extension of the surgical incision beyond coverage of T12 dermatome.
  • Prolonged time of surgery > 5 hours.
  • Hepatectomy surgery combined with another organ resection.
  • Patients with hypersensitivity to local anesthetics.
  • History of psychiatric problems.
  • Recent history of analgesic drugs including opioid abuse or addiction.
  • Coagulopathy (International normalized ratio [INR] > 1.4).
  • Localized infection at the block site.
  • Morbidly obese patients.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External Oblique Intercostal Plane block
Patients in this group will receive External Oblique Intercostal plane block intraoperatively before the surgery.
Procedure: External Oblique Intercostal Plane Block
The block is performed before skin incision by a specialized anesthetist. With the patient positioned in the supine position with their ipsilateral arm abducted, the skin was sterilized, using the high frequency linear probe (M-Turbo HF 38 transducer 13- 6 MHz) of Fujifilm Sonosite ultrasound is placed over the sixth rib medial to the anterior axillary line approximately in midclavicular line in a parasagittal orientation. A 20-guage needle is inserted in a cephalocaudal direction, and the external oblique intercostal plane was hydro dissected with saline. After hydro dissection, the needle is advanced 1 to 2 cm, and 20 mL of 0.25% bupivacaine (Sunny Pharmaceutical) with 4 mg dexamethasone as an additive was administered. The same procedure will be done at the other side (bilateral external oblique intercostal plane block).
Active Comparator: Patient controlled analgesia
Patient will be on patient control analgesia after the surgery.
Device: Patient controlled analgesia
Patients in group will receive intravenous patient controlled analgesia device 100 ml (Accuafuser 100 mL, basal rate 4 mL/hr., bolus 0.5 mL/time, and lock time 15 minutes) for postoperative pain management that will contain 30 mg morphine (loading dose0.1mg/kg) will be given by infusion over 10 minutes then accuafuser will be connected),8 mg dexamethasone and 8 mg ondansetron diluted in 100 ml saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours)
Time Frame: twenty four hours.
twenty four hours.

Collaborators and Investigators

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

Sponsor

Sherif Alaa Embaby

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

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)

April 1, 2025

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-189-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Once the study is over and published, all the data will be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Provide Post Hepatectomy Pain Control

Clinical Trials on External Oblique Intercostal Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe