- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07396545
External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastrectomy (EOIB AND ESPB)
Effects of Ultrasound-guided External Oblique Intercostal Block Versus Erector Spinae Plane Block on Postoperative Pain in Laparoscopic Radical Gastrectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Laparoscopic radical gastrectomy (including subtotal and total gastrectomy) is the most commonly used surgical approach for gastric cancer. Although this technique is less invasive than traditional open surgery, more than 50% of patients still experience moderate to severe acute pain in the early postoperative period, making effective postoperative pain management essential. Regional nerve blockade techniques have become a key component of postoperative analgesia due to their reliable analgesic effect and significant reduction in opioid consumption.
The erector spinae plane block (ESPB) is considered a relatively safe nerve block for upper abdominal surgery analgesia. However, the spread of the local anesthetic and the resulting block effect are unpredictable. Moreover, ESPB cannot be performed with the patient in the supine position and may present technical challenges in obese patients.
The external oblique intercostal plane block (EOIB) is a recently proposed regional block technique for the upper abdomen. This block involves injecting local anesthetic into the superficial fascial plane between the external oblique muscle and the intercostal muscles, thereby blocking the anterior rami and cutaneous branches of the intercostal nerves from T6-T10, which can provide effective analgesia for upper abdominal incision areas.
Nevertheless, current research on the analgesic effect of EOIB after laparoscopic radical gastrectomy remains limited, particularly lacking high-quality, prospective, randomized controlled studies to verify whether EOIB can achieve analgesic effects comparable to those of ESPB. Therefore, this study adopts a non-inferiority randomized controlled trial design to verify that the postoperative analgesic effect of EOIB is not inferior to that of ESPB, providing more options for regional analgesia strategies in laparoscopic radical gastrectomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: lingzi Yin, Doctoral
- Phone Number: 86-951-674-3252
- Email: eleven87670@163.com
Study Locations
-
-
Ningxia
-
Yinchuan, Ningxia, China
- Recruiting
- General Hospital of Ningxia Medical University
-
Contact:
- lingzi Yin, Doctoral
- Phone Number: 86-951-674-3252
- Email: eleven87670@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged over 18 years
- Classified as ASA I-III
- Scheduled for elective laparoscopic radical gastrectomy under general anesthesia
- Voluntarily participated and provided written informed consent.
Exclusion Criteria:
- Chronic opioid dependence or prior use of analgesic medications for >3 months;
- Inability to communicate due to severe dementia, language barriers, or terminal illness;
- History of central and/or peripheral nervous system disorders;
- Severe renal insufficiency (serum creatinine >442 μmol/L or requiring renal replacement therapy) or severe hepatic insufficiency (Child-Pugh class C);
- Allergy to local anesthetics.
- Expected to be transferred to ICU after surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ESPB
After patients entering the operating room, an intravenous line was established, and Erector Spinae Plane Block was performed under ultrasound guidance.
|
With the patient in the lateral decubitus position (surgical side up), a low-frequency convex array probe (2-5 MHz) is used to perform a sagittal scan approximately 2-3 cm lateral to the spinous process of T8 or T9.
The transverse process and the erector spinae muscle are identified.
Using an out-of-plane technique, a 21G, 100mm block needle is advanced until contact is made with the transverse process.
The needle is then withdrawn 1-2 mm to position its tip within the fascial plane deep to the erector spinae muscle and superficial to the transverse process.
30 ml of 0.375% ropivacaine is injected on each side, for a bilateral administration.
|
|
Experimental: EOIB
After patients entering the operating room, an intravenous line was established, and External Oblique Intercostal Plane Block was performed under ultrasound guidance.
|
With the patient in the supine position, a high-frequency linear array probe (6-15 MHz) is used to perform a sagittal parasagittal oblique scan at the level of the 6th rib, between the right anterior axillary line and midclavicular line.
The external oblique muscle, intercostal muscles, and ribs are identified.
Using an in-plane technique, a 21G, 100mm block needle is inserted from a superomedial to inferolateral direction, with the needle tip positioned in the plane between the external oblique muscle and the intercostal muscles at the caudal edge of the 6th rib.
30ml of 0.375% ropivacaine is injected on each side, for a bilateral administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative opioid consumption within 24 hours postoperatively
Time Frame: 24 hours after surgery
|
Cumulative opioid consumption within 24 hours postoperatively.
Conversion to morphine equivalent dose (mg)
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 2, 6, 12, 24, 48, and 72 hours postoperatively
|
Pain at rest and during coughing will be assessed using the Numerical Rating Scale (NRS, 0-10) at 2, 6, 12, 24, 48, and 72 hours postoperatively.0
represents no pain, and 10 represents the most pain.
|
2, 6, 12, 24, 48, and 72 hours postoperatively
|
|
Quality of Recovery
Time Frame: 24,48,72 hours after surgery
|
The 15-item Quality of Recovery scale (QoR-15) was used for assessment at 24, 48, and 72 hours postoperatively.
The higher the score, the better the recovery quality
|
24,48,72 hours after surgery
|
|
sleep quality
Time Frame: 24,48,72 hours after surgery
|
Sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ) on postoperative nights.0 points represent very poor sleep, while 100 points represent very good sleep
|
24,48,72 hours after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: Xinli Ni, Doctoral, 86-951-674-3252
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lingzi-2026-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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