Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy

NCT06541613 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: PT (831)
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

External Oblique Intercostal Plane Block; Laparoscopic Cholecystectomy

Keywords

EOIPB, alternative analgesic, laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• total morphine consumption

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

  the first 24 hours postoperatively

Secondary Outcomes (1)

• NRS

  6 hours postoperatively

Study Arms (2)

The EOIPB ( E) group

EXPERIMENTAL

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 Control Group (C)

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: bupivacaine

The EOIPB ( E) group

normal saline injection OTHER

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

Also known as: Placebo

The Control Group (C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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), -

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 02, Egypt

Location

Related Publications (3)

• 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.

  PMID: 32158311 BACKGROUND

• 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.

  PMID: 30635518 BACKGROUND

• 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.

  PMID: 35249704 BACKGROUND

MeSH Terms

Interventions

Anesthetics, Local; Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Moshira Amer, M.D.

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the investigator responsible for block administration will not be aware of the content of the medications prepared whether they are the local anesthetics or normal saline. also the patients will not be aware of the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: 38 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.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: August 7, 2024
• Study Start: April 25, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 15, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)