EOIB for Pain After Laparoscopic Cholecystectomy

NCT ID: NCT07332546

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-04-20

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.

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.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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 ).

Group Type: EXPERIMENTAL

External oblique intercostal block (EOIB)

Intervention Type: 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).

Control Group

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

Group Type: SHAM_COMPARATOR

Standard care without regional block

Intervention Type: 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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shiyou Wei

OTHER

Sponsor Role: lead

Responsible Party

Shiyou Wei

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xin Lv, PhD

Role: STUDY_CHAIR

Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

Locations

Tianmen First People's Hospital

Tianmen, Hubei, China

Countries

China

Central Contacts

Shiyou Wei, Doc

Role: CONTACT

lovewishyou@tongji.edu.cn

15601680288

Shiyou Y Wei

Role: CONTACT

lovewishyou@tongji.edu.cn

15601680288

Other Identifiers

20250322

Identifier Type: -

Identifier Source: org_study_id