Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

August 2, 2024 updated by: Moshira sayed mohamed, Theodor Bilharz Research Institute

Bilateral External Oblique Intercostal Plane Block (EOIPB) an Alternative Analgesic Technique in Patients Scheduled for Laparoscopic Cholecystectomy: A Randomized Controlled Study

Pain after laparoscopic cholecystectomy (LC) is a common complaint that prolongs hospital stay and thus increases morbidity. There are three primary sources of pain after LC, incision site, local and systemic effects of pneumoperitoneum, and post cholecystectomy wound to the liver. External oblique intercostal plane block (EOIPB) has recently been described as a novel block for upper abdomen surgery. the probable mechanism of the block with the dyeing of both the anterior and lateral branches of the intercostal nerves T7-T10. This block also provides a dermatomal sensory block at the T6-T10 level in the anterior axillary region and the T6-T9 level in the midline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

EOIPB has the benefit of being performed with the patient supine when compared with QLB and ESPB. It also has an advantage over SIPB in that it produces greater analgesia throughout the midline of the abdomen. The hypothesis of this randomized study is that patients who will undergo EOIPB will have lower opioid consumption in the postoperative period than patients who receive routine multimodal analgesia alone. The study aims to assess pain control in the immediate postoperative period by assessment of Numerical Rating scale (NRS), time for the first analgesic request as well as total morphine intake in the first 24 hours after surgery.

Study design:

This is a prospective, randomized double blinded control study which will be conducted in department of anesthesia and surgical Intensive care unit at Theodor Bilharz Research Institute after approval by research ethics committee and patient informed consent. 50 patients will be enrolled in the study and divided into two groups either (EOIPB group (E) or Control group (C). Randomization will be done by allocation 1:1 of scheduled cases per day.

Sample size: 38 patients

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Egypt
      • Giza, Egypt, 02
        • Theodor Bilharz Research Institute

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. ASA 1-2.
  2. Patients undergoing elective laparoscopic cholecystectomy with estimated pneumoperitoneum time of 60 to 90 min.-

Exclusion Criteria:

  1. Coagulation disorders.
  2. Liver/ kidney disease
  3. Previous abdominal surgery
  4. Infection in the block site
  5. Chronic opioid use
  6. Local anesthetic (LA) allergy,
  7. Pregnancy, or BMI ≥35 kg/m2
  8. Duration of surgery (≥ 2.5 h due to surgical complications), -

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The EOIPB ( E) group
EOIPB will be administered by a single anesthetists following the intubation. A linear ultrasound transducer is positioned in the sagittal plane at the 6th rib level, between the anterior axillary and midclavicular lines. The ribs, lungs, pleura, intercostal muscles, external oblique muscle and subcutaneous tissue are visualized in the image. The in-plane technique with a 22G, 80 mm block needle is used to inject 30 ml of 0.25% bupivacaine into the external oblique intercostal plane on both sides.
Drug: local anesthetic injection (bupivacaine)
The in-plane technique with a 22G, 80 mm block needle is used to inject 30 ml of 0.25% bupivacaine into the external oblique intercostal plane on both sides.
Other Names:
  • bupivacaine
Placebo Comparator: The Control Group (C)
Control group of patients will receive standard multimodal analgesia. Using us guidance, the external oblique intercostal plane is identified and 30 ml normal saline instead of LA will be injected in the control group.
Other: normal saline injection
the control group will receive 30ml of normal saline bilaterally into the external oblique intercostal plane on both sides
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total morphine consumption
Time Frame: the first 24 hours postoperatively
the total analgesic (morphine) requirements in the first 24 hours postoperatively will be calculated
the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS
Time Frame: 6 hours postoperatively
Numerical rating scale for pain recorded at 15,30, 60 minutes postopetaively.
6 hours postoperatively

Collaborators and Investigators

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

Sponsor

Theodor Bilharz Research Institute

Investigators

  • Principal Investigator: Moshira Amer, M.D., Theodor Bilharz Research Institute

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 (Actual)

April 25, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT (831)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the data of the participants will be available upon request from the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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