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

NCT ID: NCT06822309

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-11-01

Brief Summary

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.

Conditions

Provide Post Hepatectomy Pain Control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

External Oblique Intercostal Plane block

Patients in this group will receive External Oblique Intercostal plane block intraoperatively before the surgery.

Group Type: EXPERIMENTAL

External Oblique Intercostal Plane Block

Intervention Type: 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

Patient will be on patient control analgesia after the surgery.

Group Type: ACTIVE_COMPARATOR

Patient controlled analgesia

Intervention Type: 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.

Interventions

External Oblique Intercostal Plane Block

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).

Intervention Type: PROCEDURE

Patient controlled analgesia

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Sherif Alaa Embaby

OTHER

Sponsor Role: lead

Responsible Party

Sherif Alaa Embaby

Consultant of Anaesthesia, ICU and pain management.

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Sherif A Embaby, Consultant

Role: CONTACT

sherif.embaby@kasralainy.edu.eg

+447777918923

References

Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.

Reference Type: BACKGROUND

PMID: 36086688 (View on PubMed)

Other Identifiers

MS-189-2024

Identifier Type: -

Identifier Source: org_study_id