Dual-chamber patient-controlled pain relief after laparoscopic sleeve gastrectomy
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | Female |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 1 site (Seongnam-si, Gyunggi-do) |
| Trial ID | NCT07051109 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seongnam-si, Gyunggi-do
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.