Trials / Not Yet Recruiting
Not Yet RecruitingNCT07332546
EOIB for Pain After Laparoscopic Cholecystectomy
External Oblique Intercostal Block for Postoperative Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- Shiyou Wei · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
| 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. |
Timeline
- Start date
- 2026-01-15
- Primary completion
- 2026-04-15
- Completion
- 2026-04-20
- First posted
- 2026-01-12
- Last updated
- 2026-01-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07332546. Inclusion in this directory is not an endorsement.