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NCT Number: NCT07331441

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Location status: Recruiting

Location contact

Jun Zhang Fudan University Shanghai Cancer Center

CONTACT

[email protected]

13817153025

About this study

Postoperative pain after major upper abdominal surgery is common and may delay recovery and increase opioid-related adverse effects. The External Oblique Intercostal Plane Block (EOIB) is a novel fascial plane block intended to improve analgesia for upper abdominal incisions.

This study is a prospective, single-center, randomized, assessor-blinded controlled trial in adults (18-85 years, ASA I-III) scheduled for elective major upper abdominal laparoscopic-assisted surgery (e.g., gastric, hepatic, gallbladder, pancreatic procedures) with expected operative time ≥2 hours and planned use of IV patient-controlled analgesia (PCA). Participants will be randomized 1:1 using a computer-generated, variable block-size sequence with allocation concealment via opaque sealed envelopes. The block-performing anesthesiologist will not collect outcomes; outcome assessors will be blinded to group assignment.

After induction of general anesthesia and before surgical incision, patients in the intervention group will receive ultrasound-guided bilateral EOIB at the 6th rib level using an in-plane technique; 25 mL 0.3% ropivacaine per side. Control participants will receive no regional block. All participants will receive standardized multimodal analgesia including IV PCA, antiemetic prophylaxis (dexamethasone 5 mg; ondansetron as needed), and NSAID use per ERAS practice.

The primary endpoint is total opioid consumption during the first 24 hours after surgery, expressed as IV morphine milligram equivalents (MME), including PCA and rescue opioids. Secondary outcomes include postoperative pain scores (0-10 verbal rating scale) at prespecified time points (including 24, 48, and 72 hours; at rest and with activity as applicable), quality of recovery (QoR-15 at 24/48/72 hours), opioid consumption at 24-48 hours, postoperative nausea and vomiting within 72 hours, intraoperative hemodynamic events, time to first flatus, and postoperative length of stay.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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, 25 mL 0.3% ropivacaine per side is injected between the external oblique muscle and the intercostal muscle. Standard multimodal analgesia is also provided to all participants.

Other names: EOIB

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.

Other names: Usual analgesia

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Postoperative Pain Score Within 24 Hours Postoperatively

    Time frame: Within 24 hours postoperatively

    Pain is assessed using a Verbal Rating Scale (VRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments are performed each morning and evening. A difference of ≥1 point between groups is considered clinically significant.

  2. Postoperative Recovery Quality at 24 Hours Postoperatively

    Time frame: 24 hours postoperatively

    Recovery quality is evaluated using the QoR-15 scale (a 15-item questionnaire measuring physical comfort, emotional state, and functional recovery). A difference of ≥6 points between groups is considered clinically significant.

Other outcomes

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

    Time frame: 25-48 hours postoperatively

    Total opioid consumption includes doses from intravenous patient-controlled analgesia (IV PCA) and rescue analgesics, converted to Morphine Milligram Equivalents (MME). A reduction of ≥10 mg MME between groups is considered clinically significant.

  2. Postoperative Pain Score Postoperatively

    Time frame: 25~72 hours postoperatively

    Pain is assessed using a Verbal Rating Scale (VRS) with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Assessments are performed each morning and evening. A difference of ≥1 point between groups is considered clinically significant.

  3. Postoperative Recovery Quality Postoperatively

    Time frame: 25~72 hours postoperatively

    Recovery quality is evaluated using the QoR-15 scale (a 15-item questionnaire measuring physical comfort, emotional state, and functional recovery). A difference of ≥6 points between groups is considered clinically significant.

  4. Incidence of Nausea and Vomiting Postoperatively

    Time frame: Within 72 hours postoperatively (stratified by 1-6h, 7-24h, 25-48h, 49-72h)

    The number of patients experiencing nausea or vomiting is recorded, stratified by four time periods: 1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours postoperatively.

  5. Intraoperative Incidence of Hypotension and Hypertension

    Time frame: Intraoperatively (during surgery)

    Intraoperative hypotension is defined as systolic blood pressure <90 mmHg or a 30% reduction from baseline; intraoperative hypertension is defined as systolic blood pressure >160 mmHg or a 30% increase from baseline. The incidence of both conditions is recorded.

  6. Time to First Flatus Postoperatively

    Time frame: From surgery completion to first flatus (up to 72 hours postoperatively)

    The duration from surgery completion to the patient's first flatus is recorded as an indicator of gastrointestinal function recovery.

  7. Postoperative Hospital Stay Duration

    Time frame: From surgery completion to hospital discharge (typically 3-7 days postoperatively)

    The duration from surgery completion to hospital discharge is recorded.

Study contacts

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

Jun Zhang, PhD

CONTACT

[email protected]

0216417559001

Sponsors and collaborators

Lead sponsor

Jun Zhang

Other

Registry information

Official study title

External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Jun 25, 2026

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.

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