Clinical trial NCT06541613: Bilateral External Oblique Intercostal Plane Block in Laparoscopic Cholecystectomy
Official title: Bilateral External Oblique Intercostal Plane Block (EOIPB) an Alternative Analgesic Technique in Patients Scheduled for Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: External Oblique Intercostal Plane Block
Laparoscopic Cholecystectomy
Keywords: EOIPB, alternative analgesic, laparoscopic cholecystectomy
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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

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), -

Primary outcomes:
measure: total morphine consumption
timeFrame: the first 24 hours postoperatively
Secondary outcomes:
measure: NRS
timeFrame: 6 hours postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
affiliation: Theodor Bilharz Research Institute
name: Moshira Amer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.