Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

Theodor Bilharz Research Institute

Status and phase: Completed; Phase 4

Conditions: External Oblique Intercostal Plane Block; Laparoscopic Cholecystectomy

Treatments: Other: normal saline injection; Drug: local anesthetic injection (bupivacaine)

Study type: Interventional

Funder types: Other

Identifiers

NCT06541613

PT (831)

Details and patient eligibility

About

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.

Full 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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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), -

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

The EOIPB ( E) group

Experimental group

Description:

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.

Treatment:

Drug: local anesthetic injection (bupivacaine)

The Control Group (C)

Placebo Comparator group

Description:

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.

Treatment:

Other: normal saline injection