EOIB for Pain After Laparoscopic Cholecystectomy

External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: External oblique intercostal block (EOIB); Other: Standard care without regional block

Detailed Description

Laparoscopic cholecystectomy is a common procedure, yet postoperative pain remains clinically significant despite routine multimodal analgesia, and opioid use may cause adverse effects. External oblique intercostal block (EOIB) is a newer ultrasound-guided fascial plane block that may provide effective analgesia for upper abdominal surgery.

This study is a prospective, randomized, controlled, assessor-blinded trial in patients undergoing elective laparoscopic cholecystectomy. A total of 56 participants will be randomized 1:1 to receive either bilateral ultrasound-guided EOIB or no regional block. EOIB will be performed bilaterally under ultrasound guidance at the level of the 6th rib in the 6th-7th intercostal space using an in-plane technique, with 15 mL of study local anesthetic mixture injected per side. Postoperatively, all participants will receive standardized multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with butorphanol and non-opioid analgesics per protocol.

The primary outcome is total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores (VRS) at prespecified time points, quality of recovery (QoR-15) at 24 hours, opioid consumption from 24-48 hours, postoperative nausea and vomiting, intraoperative hemodynamic events, time to first flatus, and length of hospital stay. The trial aims to determine whether adding bilateral EOIB to standard analgesia can reduce opioid requirements and improve recovery after laparoscopic cholecystectomy.

Note for your protocol alignment: your document contains a potential inconsistency about "no other opioids within 72 hours" versus recording "rescue opioid" use; you may want to standardize this wording before final submission.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyou Wei, Doc; Phone Number: 15601680288; Email: lovewishyou@tongji.edu.cn
• Study Contact Backup: Name: Shiyou Y Wei; Phone Number: 15601680288; Email: lovewishyou@tongji.edu.cn

Study Locations

• China
  • Hubei
    • Tianmen, Hubei, China, 431700
      • Tianmen First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EOIB Group; 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); 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).
Sham Comparator: Control Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (VRS) at 24 hours after surgery	Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0 = no pain, 10 = worst pain imaginable) at 24 hours after surgery.	24 hours after surgery
Quality of recovery at 24 hours (QoR-15 score)	Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15); total score at 24 hours postoperatively.	24 hours after surgery
Butorphanol consumption from 24 to 48 hours after surgery	Total butorphanol consumption recorded during postoperative hours 24-48 (including PCA-delivered dose and any additional butorphanol administered).	24-48 hours after surgery
Pain score (VRS) at 48 and 72 hours after surgery	Postoperative pain intensity measured using the Verbal Rating Scale (VRS; 0-10) at 48 hours and 72 hours after surgery.	48 hours and 72 hours after surgery
Incidence of postoperative nausea and vomiting within 72 hours	Incidence of nausea and/or vomiting recorded during postoperative time intervals (1-6 h, 7-24 h, 25-48 h, and 49-72 h); summarized up to 72 hours.	1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)
Incidence of intraoperative hypotension and hypertension	Incidence of intraoperative hypotension and intraoperative hypertension during surgery, recorded per protocol definitions. Blood pressure increase exceeding 30% of the baseline value is used as the measurement criterion.	Intraoperative period
Time to first flatus	Time from the end of surgery to the first passage of flatus.	Within 3 days after surgery
Postoperative length of hospital stay	Duration of hospital stay after surgery, measured from the time of surgery to hospital discharge.	Within 7 days after surgery

Collaborators and Investigators

• Sponsor: Shiyou Wei
• Investigators: Study Chair: Xin Lv, PhD, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nerve Block; Ultrasonography, Interventional; External oblique intercostal block; Quality of recovery (QoR-15)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 20250322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No