NCT07051109

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Postoperative nausea and vomiting (PONV) are the most common complications that can occur after general anesthesia. Postoperative use of opioids and morbid obesity have been reported as risk factors of PONV. In this study, the investigators aimed to compare the degree of postoperative side effects and pain control when an intravenous patient-controlled analgesia combining fentanyl and ketorolac via a dual-chamber device was provided to participants undergoing laparoscopic sleeve gastrectomy.

Detailed description

Morbidly obese patients undergoing laparoscopic sleeve gastrectomy experience a relatively high incidence of postoperative nausea and vomiting, but no effective treatment method has been established yet to prevent them. Through this study, the investigators can expect that if a dual-chamber patient-controlled analgesia device can provide effective analgesia while reducing the amount of opioid used, and thus reduce postoperative nausea and vomiting, it can have the effect of increasing the quality of recovery and satisfaction of participants who have undergone laparoscopic sleeve gastrectomy. Furthermore, this dual-chamber patient-controlled analgesia device can be applied to various surgeries and various patient groups who are at risk for postoperative nausea and vomiting, and it is expected that it can be adapted as one of the methods to prevent postoperative nausea and vomiting.

Conditions

• Morbid Obesity
• PCA
• Analgesia
• PONV

Interventions

Type	Name	Description
DEVICE	multimodal analgesia via dual-chamber PCA	combination of fentanyl and ketorolac through dual-chamber PCA
DEVICE	single regimen (only fentanyl)	fentanyl only through dual-chamber PCA

Timeline

• Start date: 2022-10-11
• Primary completion: 2025-08-11
• Completion: 2026-03-11
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: South Korea