An interventional study of External Oblique Intercostal Plane Block and Standard multimodal analgesia in Abdominal Surgery and Postoperative Pain, sponsored by Jun Zhang. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Jun Zhang · Not applicable, Interventional, and Treatment
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.
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 78 is close to the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Jun Zhang is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ultrasound-guided bilateral External Oblique Intercostal Plane Block (EOIB) after induction of general anesthesia and before surgical incision, using 0.3% ropivacaine (25 mL per side), in addition to standard multimodal analgesia (including IV PCA and ERAS-based non-opioid analgesics).
Procedure: External Oblique Intercostal Plane Block
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
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.
Also known as: EOIB
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
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)
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 postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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 postoperatively
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)
Intraoperative Incidence of Hypotension and Hypertension
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.
Time frame: Intraoperatively (during surgery)
Time to First Flatus Postoperatively
The duration from surgery completion to the patient's first flatus is recorded as an indicator of gastrointestinal function recovery.
Time frame: From surgery completion to first flatus (up to 72 hours postoperatively)
Postoperative Hospital Stay Duration
The duration from surgery completion to hospital discharge is recorded.
Time frame: From surgery completion to hospital discharge (typically 3-7 days postoperatively)
Plan to share: No
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Jun Zhang