EOIB for Pain After Laparoscopic Cholecystectomy

NCT07332546 | Not Yet Recruiting

• 1 other identifier: 20250322
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, controlled, assessor-blinded trial will evaluate whether bilateral ultrasound-guided external oblique intercostal block (EOIB) reduces postoperative opioid consumption and improves pain control after laparoscopic cholecystectomy, compared with no block.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy

Keywords

External oblique intercostal block; Ultrasonography, Interventional; Nerve Block; Quality of recovery (QoR-15)

Outcome Measures

Primary Outcomes (1)

• Total Butorphanolconsumption in the first 24 hours after surgery

  Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant.

  0-24 hours after surgery

Secondary Outcomes (8)

• Pain score (VRS) at 24 hours after surgery

  24 hours after surgery

• Quality of recovery at 24 hours (QoR-15 score)

  24 hours after surgery

• Butorphanol consumption from 24 to 48 hours after surgery

  24-48 hours after surgery

• Pain score (VRS) at 48 and 72 hours after surgery

  48 hours and 72 hours after surgery

• Incidence of postoperative nausea and vomiting within 72 hours

  1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)

Study Arms (2)

EOIB Group

EXPERIMENTAL

Participants receive bilateral ultrasound-guided external oblique intercostal block (EOIB) (15 mL of the study local anesthetic mixture per side) in addition to standard general anesthesia and standardized postoperative analgesia (IV PCA butorphanol ).

Other: External oblique intercostal block (EOIB)

Control Group

SHAM COMPARATOR

Participants do not receive any regional block. They receive standard general anesthesia and standardized postoperative analgesia only (IV PCA butorphanol).

Other: Standard care without regional block

Interventions

External oblique intercostal block (EOIB) OTHER

Bilateral ultrasound-guided external oblique intercostal block performed under sterile conditions after induction of general anesthesia and before surgical incision. Using an in-plane technique, the block is performed at the level of the 6th rib in the 6th-7th intercostal space. A local anesthetic mixture is injected with a total volume of 15 mL per side (prepared by mixing 0.75% ropivacaine with normal saline).

EOIB Group

Standard care without regional block OTHER

Participants do not receive any regional anesthesia/nerve block (including external oblique intercostal block). All participants receive standard general anesthesia and the same standardized postoperative multimodal analgesia regimen as per protocol, including intravenous patient-controlled analgesia (PCA) with butorphanol.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-85 years, regardless of gender
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Scheduled for elective laparoscopic cholecystectomy
• Ability to use the intravenous patient-controlled analgesia (IV PCA) system

You may not qualify if:

• Hepatic disease (e.g., liver enzyme levels ≥ 2× the upper limit of normal)
• Renal disease (e.g., serum creatinine levels ≥ 2× the upper limit of normal)
• Allergy or known hypersensitivity to local anesthetics
• Females who are pregnant or lactating
• Conversion to open surgery
• Coagulopathy or current use of anticoagulant medications
• Opioid use for more than 2 weeks in the past 6 months

Sponsors & Collaborators

• Shiyou Wei: lead

Study Sites (1)

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Xin Lv, PhD

  Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

  STUDY CHAIR

Central Study Contacts

Shiyou Wei, Doc

CONTACT

15601680288; lovewishyou@tongji.edu.cn

Shiyou Y Wei

CONTACT

15601680288; lovewishyou@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group assignment. Participants and clinical care providers/investigators are not blinded because the control group does not receive a regional block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized 1:1 to one of two parallel groups: bilateral ultrasound-guided external oblique intercostal block (EOIB) or control (no regional block). Each participant receives only the assigned intervention.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: April 20, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)