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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
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).
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.
Tianmen First People's Hospital
Tianmen, Hubei, China
RECRUITINGTotal 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 surgery
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 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 1-6 hours, 7-24 hours, 25-48 hours, and 49-72 hours after surgery (up to 72 hours)
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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.
Time frame: Intraoperative period
Time to first flatus
Time from the end of surgery to the first passage of flatus.
Time frame: 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.
Time frame: Within 7 days after surgery