Clinical Trials Directory

Trials / Completed

CompletedNCT06541613

Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Theodor Bilharz Research Institute · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

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

Conditions

Interventions

TypeNameDescription
DRUGlocal 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.
OTHERnormal saline injectionthe control group will receive 30ml of normal saline bilaterally into the external oblique intercostal plane on both sides

Timeline

Start date
2024-04-25
Primary completion
2024-07-01
Completion
2024-07-15
First posted
2024-08-07
Last updated
2024-08-07

Locations

1 site across 1 country: Egypt

Regulatory

Source: ClinicalTrials.gov record NCT06541613. Inclusion in this directory is not an endorsement.