NCT06822309

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 6, 2025

Last Update Submit

February 11, 2025

Conditions

Keywords

External Oblique Intercostal blocksubcostal incisionhepatectomyPatient control analgesia

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

EXPERIMENTAL

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

Procedure: External Oblique Intercostal Plane Block

Patient controlled analgesia

ACTIVE COMPARATOR

Patient will be on patient control analgesia after the surgery.

Device: Patient controlled analgesia

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).

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.

Patient controlled analgesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Central Study Contacts

Sherif A Embaby, Consultant

CONTACT

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