NCT07396545

Brief Summary

Postoperative pain is highly prevalent following laparoscopic radical gastrectomy. Although the erector spinae plane block (ESPB) can effectively alleviate this pain, it still has many limitations. The external oblique intercostal plane block (EOIB) is a novel nerve block technique that may provide well postoperative analgesia for upper abdominal surgery. Therefore, this study employs a non-inferiority randomized controlled trial design to verify that the analgesic effect of EOIB is not inferior to that of ESPB, thereby offering more options for regional analgesia strategies in laparoscopic radical gastrectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
9mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 12, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2027

Expected
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2027

Last Updated

March 16, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 1, 2026

Last Update Submit

March 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption within 24 hours postoperatively

    Cumulative opioid consumption within 24 hours postoperatively. Conversion to morphine equivalent dose (mg)

    24 hours after surgery

Secondary Outcomes (3)

  • Pain Intensity

    2, 6, 12, 24, 48, and 72 hours postoperatively

  • Quality of Recovery

    24,48,72 hours after surgery

  • sleep quality

    24,48,72 hours after surgery

Study Arms (2)

ESPB

EXPERIMENTAL

After patients entering the operating room, an intravenous line was established, and Erector Spinae Plane Block was performed under ultrasound guidance.

Procedure: Erector Spinae Plane Block (ESPB) group

EOIB

EXPERIMENTAL

After patients entering the operating room, an intravenous line was established, and External Oblique Intercostal Plane Block was performed under ultrasound guidance.

Procedure: External Oblique Intercostal Plane Block

Interventions

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.

EOIB

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.

ESPB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Xinli Ni, Doctoral

    86-951-674-3252

    STUDY CHAIR

Central Study Contacts

Lingzi Yin, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
On the day of surgery, after the induction of general anesthesia, the study coordinator opened the corresponding envelope in the order of recruitment. Patients were randomly assigned to receive either EOIB or ESPB, which was performed preoperatively by an experienced anesthesiologist. The anesthesiologist was aware of the intervention, but all patients, data investigator and postoperative follow-up remained blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

March 12, 2026

Primary Completion (Estimated)

February 6, 2027

Study Completion (Estimated)

February 9, 2027

Last Updated

March 16, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations