Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

NCT ID: NCT06541613

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-25
• Study Completion Date: 2024-07-15

Brief 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

External Oblique Intercostal Plane Block; Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

local anesthetic injection (bupivacaine)

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

normal saline injection

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

normal saline injection

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

Intervention Type: OTHER

Other Intervention Names

bupivacaine; Placebo

Eligibility Criteria

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), -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theodor Bilharz Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Moshira sayed mohamed

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moshira Amer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Theodor Bilharz Research Institute

Locations

Theodor Bilharz Research Institute

Giza, , Egypt

Countries

Egypt

References

Selvi O, Tulgar S, Senturk O, Serifsoy TE, Thomas DT, Deveci U, Ozer Z. Is a Combination of the Serratus Intercostal Plane Block and Rectus Sheath Block Superior to the Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy? Eurasian J Med. 2020 Feb;52(1):34-37. doi: 10.5152/eurasianjmed.2019.19048.

Reference Type: BACKGROUND

PMID: 32158311 (View on PubMed)

Hamilton DL, Manickam BP, Wilson MAJ, Abdel Meguid E. External oblique fascial plane block. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100256. doi: 10.1136/rapm-2018-100256. Online ahead of print. No abstract available.

Reference Type: BACKGROUND

PMID: 30635518 (View on PubMed)

White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.

Reference Type: BACKGROUND

PMID: 35249704 (View on PubMed)

Other Identifiers

PT (831)

Identifier Type: -

Identifier Source: org_study_id