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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EOIB Block | Experimental | 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 25-48 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhang, PhD | Contact | 0216417559001 | snapzhang@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Zhang, PhD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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. |
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| 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. |
| 24 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. | 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. | 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. | 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. | 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. | 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. | From surgery completion to hospital discharge (typically 3-7 days postoperatively) |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |