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NCT Number: NCT06822309

Bilateral External Oblique Intercostal Plane Block in Post Operative Pain Management in Hepatectomy

The majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Although epidural catheters are efficient to provide perioperative analgesia, in this type of surgery patients may be more susceptible to catheter related complications due to the alteration in coagulation parameters. That is why safer alternatives are sought for those patients. The use of patient-controlled analgesia (PCA) for postoperative pain management improves patients' quality of recovery. However, there are many concerns regarding the type of opioids used in PCA such as overdosing, underdosing, and the effect of the hepatectomy on the drug metabolism in those patients. External oblique intercostal plane block (EOI block) is a relatively novel block used in upper abdominal incisions especially subcostal laparotomy to provide intraoperative and postoperative analgesia.

This study aims to compare the efficacy of Bilateral External Oblique Intercostal Plain Block versus PCA in pain management and reduction of opioid use in hepatectomy surgery done by subcostal incision.

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Key information

Conditions

Provide Post Hepatectomy Pain Control

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 and ≤ 65 Years.
Both sexes.
Patients will be scheduled for hepatectomy surgery.
Body mass index (BMI) 18.5-30.0 /m 2 .

Exclusion criteria

Extension of the surgical incision beyond coverage of T12 dermatome.
Prolonged time of surgery > 5 hours.
Hepatectomy surgery combined with another organ resection.
Patients with hypersensitivity to local anesthetics.
History of psychiatric problems.
Recent history of analgesic drugs including opioid abuse or addiction.
Coagulopathy (International normalized ratio [INR] > 1.4).
Localized infection at the block site.
Morbidly obese patients.

Treatment and study plan

External Oblique Intercostal Plane Block

Procedure

The block is performed before skin incision by a specialized anesthetist. With the patient positioned in the supine position with their ipsilateral arm abducted, the skin was sterilized, using the high frequency linear probe (M-Turbo HF 38 transducer 13- 6 MHz) of Fujifilm Sonosite ultrasound is placed over the sixth rib medial to the anterior axillary line approximately in midclavicular line in a parasagittal orientation. A 20-guage needle is inserted in a cephalocaudal direction, and the external oblique intercostal plane was hydro dissected with saline. After hydro dissection, the needle is advanced 1 to 2 cm, and 20 mL of 0.25% bupivacaine (Sunny Pharmaceutical) with 4 mg dexamethasone as an additive was administered. The same procedure will be done at the other side (bilateral external oblique intercostal plane block).

Patient controlled analgesia

Device

Patients in group will receive intravenous patient controlled analgesia device 100 ml (Accuafuser 100 mL, basal rate 4 mL/hr., bolus 0.5 mL/time, and lock time 15 minutes) for postoperative pain management that will contain 30 mg morphine (loading dose0.1mg/kg) will be given by infusion over 10 minutes then accuafuser will be connected),8 mg dexamethasone and 8 mg ondansetron diluted in 100 ml saline.

Primary outcomes

• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours)

Time frame: twenty four hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Sherif A Embaby, Consultant

CONTACT

[email protected]

+447777918923

Sponsors and collaborators

Lead sponsor

Sherif Alaa Embaby

Other

Registry information

Official study title

Bilateral External Oblique Intercostal Plane Block Versus Patient Controlled Analgesia (PCA) in Post Operative Pain Management in Hepatectomy Surgery.

Acronym: EOI

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Feb 12, 2025
Registry last updated: Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.