EOIB for Pain After Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShiyou Wei
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
External oblique intercostal block (EOIB)
Other interventionBilateral 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).
Standard care without regional block
Other interventionParticipants 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.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: EOIB GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention
Trial outcomes
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.
Time frame
0-24 hours after surgerySecondary outcomes
1
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.
Time frame
24 hours after surgery2
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.
Time frame
24 hours after surgery3
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).
Time frame
24-48 hours after surgery4
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.
Time frame
48 hours and 72 hours after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Source ClinicalTrials.gov