Laparoscopic Cholecystectomy, Postoperative Pain
Conditions
Keywords
External oblique intercostal block, Ultrasonography, Interventional, Nerve Block, Quality of recovery (QoR-15)
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 recovery 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.
Interventions
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).
OTHERStandard 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.
Sponsors
Shiyou Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Butorphanolconsumption in the first 24 hours after surgery | 0-24 hours after surgery | Total Butorphanol consumption during the first 24 hours postoperatively. A relative difference of 30% is considered clinically significant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score (VRS) at 24 hours after surgery | 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. |
| Quality of recovery at 24 hours (QoR-15 score) | 24 hours after surgery | Quality of recovery assessed using the 15-item Quality of Recovery questionnaire (QoR-15); total score at 24 hours postoperatively. |
| Butorphanol consumption from 24 to 48 hours after surgery | 24-48 hours after surgery | Total butorphanol consumption recorded during postoperative hours 24-48 (including PCA-delivered dose and any additional butorphanol administered). |
| Pain score (VRS) at 48 and 72 hours after surgery | 48 hours 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. |
| 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) | 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. |
| Incidence of intraoperative hypotension and hypertension | Intraoperative period | 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 to first flatus | Within 3 days after surgery | Time from the end of surgery to the first passage of flatus. |
| Postoperative length of hospital stay | Within 7 days after surgery | Duration of hospital stay after surgery, measured from the time of surgery to hospital discharge. |
Countries
China
Contacts
STUDY_CHAIRXin Lv, PhD
Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
Outcome results
None listed