Dual-chamber patient-controlled pain relief after laparoscopic sleeve gastrectomy
Official title: Comparison of Postoperative Recovery Between Dual-channel Pump for Intravenous Patient-controlled Analgesia(IV-PCA) and Conventional Single-channel Pump After Laparoscopic Sleeve Gastrectomy: a Prospective Randomized Controlled Trial
Run by Seoul National University Bundang Hospital · NCT07051109 · Data updated 2026-11-12
This test checks whether a dual-chamber IV patient-controlled pump delivering fentanyl plus ketorolac reduces pain and postoperative nausea and vomiting in adults having laparoscopic sleeve gastrectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 65 Years |
| Sex | Women only |
| Enrollment | 92 (estimated) |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyunggi-do) |
| Status | Recruiting |
| Started | October 11, 2022 |
| Main results expected | August 11, 2025 |
| Study ends | March 11, 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT07051109 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adult females (19–65 years) with morbid obesity scheduled for laparoscopic sleeve gastrectomy, ASA class 1–3, who plan to use IV-PCA after surgery.
✕Probably not a fit
Patients with hypersensitivity to fentanyl or ketorolac, significant liver or renal disease, chronic opioid dependence, or other listed contraindications are unlikely to be eligible or to gain benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional comparison contrasts a multimodal dual-chamber IV-PCA (fentanyl plus ketorolac) with a single-agent fentanyl IV-PCA in postoperative management. Participants are adult females aged 19–65 with ASA class 1–3 undergoing laparoscopic sleeve gastrectomy who request IV-PCA. Key outcomes include opioid consumption, pain scores, incidence and severity of postoperative nausea and vomiting, and patient recovery satisfaction. The trial is conducted at a single center using the dual-chamber device to attempt opioid-sparing multimodal analgesia.
Why it matters
Potential benefit: If successful, the dual-chamber PCA could reduce opioid use and postoperative nausea and vomiting, improving recovery quality and patient satisfaction after sleeve gastrectomy.
How similar studies have gone: Previous studies of multimodal analgesia combining opioids with NSAIDs have often reduced opioid requirements and sometimes reduced postoperative nausea, but direct evidence for efficacy of a dual-chamber PCA device is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult females aged 19 to 65 years * American Society of Anesthesiologists physical status (ASA class) 1 to 3 * Patients scheduled for laparoscopic sleeve gastrectomy under general anesthesia * Patients requesting the use of IV-PCA after surgery Exclusion Criteria: * Patients with hypersensitivity to the drugs used in this study (Ketorolac, Fentanyl) * Patients with alcohol or drug dependence, long-term use of opioids or analgesics * Patients with liver disease or renal failure * Patients with peptic ulcer, patients with gastrointestinal bleeding predisposition * Patients with suspected cerebrovascular hemorrhage, organic disorders of the head related to increased intracranial pressure * Patients with bronchial asthma or bronchospasm symptoms * Patients with severe respiratory depression * Nasal polyps, angioedema * Patients with or history of convulsive disease * Patients for whom the use of neuromuscular blocking agents is contraindicated
Where it's running
-
Seoul National University Bundang Hospital
Seongnam-si, Gyunggi-do, South Korea Recruiting
Study contacts
- Study coordinator: Insun Park, M.D./Ph.D.
- Email: pis121@hanmail.net
- Phone: 823178777499
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.