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Completed

NCT Number: NCT06541613

Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Theodor Bilharz Research Institute

Giza, 02, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

local anesthetic injection (bupivacaine)

Drug

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

normal saline injection

Other

the control group will receive 30ml of normal saline bilaterally into the external oblique intercostal plane on both sides

Other names: Placebo

Primary outcomes

  1. total morphine consumption

    Time frame: the first 24 hours postoperatively

    the total analgesic (morphine) requirements in the first 24 hours postoperatively will be calculated

Secondary outcomes

  1. NRS

    Time frame: 6 hours postoperatively

    Numerical rating scale for pain recorded at 15,30, 60 minutes postopetaively.

Sponsors and collaborators

Lead sponsor

Theodor Bilharz Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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