External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery

NCT07331441 | Not Yet Recruiting DMC

• 1 other identifier: 2512335-12
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain after laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery) is often severe, and inadequate analgesia may lead to increased opioid use, opioid dependence, and poor functional recovery. Current analgesic techniques such as neuraxial block have safety concerns (e.g., hypotension, neurological injury), while transversus abdominis plane (TAP) block is ineffective for blocking the lateral cutaneous branches of intercostal nerves in the upper abdomen. The External Oblique Intercostal Plane Block (EOIB) is a novel regional block technique that has shown promise in reducing postoperative opioids and pain in small-scale studies, but evidence for its use in major upper abdominal surgery is limited. This randomized controlled trial (RCT) aims to evaluate the analgesic efficacy and safety of bilateral EOIB combined with standard multimodal analgesia versus standard multimodal analgesia alone in patients undergoing elective laparoscopic major upper abdominal surgery. The primary outcome is the total postoperative opioid consumption (measured as Morphine Milligram Equivalents, MME) within 24 hours. Secondary and additional outcomes include pain scores (Verbal Rating Scale, VRS), recovery quality (QoR-15 scale), incidence of adverse events, and hospital stay.

Conditions

Abdominal Surgery; Postoperative Pain

Keywords

External Oblique Intercostal Plane Block; Postoperative Pain; Laparoscopic Surgery; Pain Management; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption within 24 hours after surgery (IV morphine milligram equivalents, MME)

  Cumulative postoperative opioid use from end of surgery to 24 hours postoperatively, including IV PCA opioids and any rescue opioids, converted to intravenous morphine milligram equivalents (MME) and reported in mg.

  0-24 hours postoperatively (from end of surgery to 24 hours after surgery)

Secondary Outcomes (2)

• Postoperative Pain Score Within 24 Hours Postoperatively

  Within 24 hours postoperatively

• Postoperative Recovery Quality at 24 Hours Postoperatively

  24 hours postoperatively

Other Outcomes (7)

• Opioid Consumption (Morphine Milligram Equivalents, MME) Within 24-48 Hours Postoperatively

  25-48 hours postoperatively

• Postoperative Pain Score Postoperatively

  25~72 hours postoperatively

• Postoperative Recovery Quality Postoperatively

  25~72 hours postoperatively

Study Arms (2)

EOIB Block

EXPERIMENTAL

Participants receive ultrasound-guided bilateral External Oblique Intercostal Plane Block (EOIB) after induction of general anesthesia and before surgical incision, using ropivacaine (15 mL per side), in addition to standard multimodal analgesia (including IV PCA and ERAS-based non-opioid analgesics).

Procedure: External Oblique Intercostal Plane Block

Usual Analgesia

SHAM COMPARATOR

Participants receive standard multimodal analgesia without any regional block. Analgesia includes IV patient-controlled analgesia (PCA) and other non-opioid analgesics per the institutional ERAS protocol.

Other: Standard multimodal analgesia

Interventions

Standard multimodal analgesia OTHER

Standard multimodal analgesia per institutional ERAS practice, including intravenous patient-controlled analgesia (IV PCA) with opioids and adjunct non-opioid analgesics (e.g., NSAIDs and/or acetaminophen) with antiemetic prophylaxis as needed. No regional block is administered.

Also known as: Usual analgesia

Usual Analgesia

External Oblique Intercostal Plane Block PROCEDURE

Ultrasound-guided bilateral external oblique intercostal plane block (EOIB) performed after induction of general anesthesia and before surgical incision. Using an in-plane technique at the 6th rib level, 15 mL per side of local anesthetic solution (ropivacaine 0.75% diluted with normal saline) is injected between the external oblique muscle and the intercostal muscle. Standard multimodal analgesia is also provided to all participants.

Also known as: EOIB

EOIB Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtain written informed consent from participants or their legal representatives
• Age between 18 and 85 years
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Scheduled for elective laparoscopic major upper abdominal surgery (e.g., gastric, hepatic, gallbladder, pancreatic surgery)
• Expected surgical duration ≥ 2 hours
• Ability to use the intravenous patient-controlled analgesia (IV PCA) system

You may not qualify if:

• Hepatic disease (liver enzyme levels ≥ 2× the upper limit of normal)
• Renal disease (serum creatinine levels ≥ 2× the upper limit of normal)
• Allergy to local anesthetics or known study-related drugs
• Pregnancy or lactation
• Low surgical incision site (not involving the upper abdominal wall innervated by T6-T10 nerves)
• Coagulopathy or current use of anticoagulant medications
• Opioid use for more than 2 weeks in the past 6 months

Sponsors & Collaborators

• Jun Zhang: lead

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jun Zhang, PhD

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Jun Zhang, PhD

CONTACT

0216417559001; snapzhang@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology of Shanghai cancer center

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 20, 2026
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share