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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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