External Oblique Intercostal Plane Block for Postoperative Analgesia After Major Upper Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorJun Zhang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
External Oblique Intercostal Plane Block
Procedure/SurgeryUltrasound-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.
Standard multimodal analgesia
Other interventionStandard 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: EOIB BlockExperimental treatment 1 intervention
Group B: Usual AnalgesiaOther 1 intervention
Trial outcomes
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.
Time frame
0-24 hours postoperatively (from end of surgery to 24 hours after surgery)Secondary outcomes
1
Postoperative Pain Score 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.
Time frame
Within 24 hours postoperatively2
Postoperative Recovery Quality at 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.
Time frame
24 hours postoperativelyOther outcomes
1
Opioid Consumption (Morphine Milligram Equivalents, MME) Within 24-48 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.
Time frame
25-48 hours postoperatively2
Postoperative Pain Score 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.
Time frame
25~72 hours postoperatively3
Postoperative Recovery Quality 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.
Time frame
25~72 hours postoperatively4
Incidence of Nausea and Vomiting Postoperatively
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.
Time frame
Within 72 hours postoperatively (stratified by 1-6h, 7-24h, 25-48h, 49-72h)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Zhang
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov