Bilateral External Oblique Intercostal Plane Block in Post Operative Pain Management in Hepatectomy
EOI
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedFebruary 12, 2025
February 1, 2025
6 months
February 6, 2025
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Rescue morphine consumption in both groups. (Total consumption of morphine rescue shots in milligram in first 2r hours)
twenty four hours.
Study Arms (2)
External Oblique Intercostal Plane block
EXPERIMENTALPatients in this group will receive External Oblique Intercostal plane block intraoperatively before the surgery.
Patient controlled analgesia
ACTIVE COMPARATORPatient will be on patient control analgesia after the surgery.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 65 Years.
- Both sexes.
- Patients will be scheduled for hepatectomy surgery.
- Body mass index (BMI) 18.5-30.0 /m 2 .
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 36086688BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant of Anaesthesia, ICU and pain management.
Study Record Dates
First Submitted
February 6, 2025
First Posted
February 12, 2025
Study Start
April 1, 2025
Primary Completion
October 1, 2025
Study Completion
November 1, 2025
Last Updated
February 12, 2025
Record last verified: 2025-02