Actively Recruiting

Phase Not Applicable
Age: 19Years - 65Years
FEMALE
ID07051109

Comparison of Postoperative Recovery Between Dual-channel and Single-channel Intravenous Patient-controlled Analgesia After Laparoscopic Sleeve Gastrectomy

Led by Seoul National University Bundang Hospital · Updated on 2025-07-03

92

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Morbidly obese women undergoing laparoscopic sleeve gastrectomy often face postoperative nausea and vomiting (PONV), which are common complications after general anesthesia. This trial evaluates whether using a dual-chamber patient-controlled analgesia (PCA) device combining fentanyl and ketorolac can reduce opioid use and decrease PONV compared to a single-chamber PCA with fentanyl alone. The study aims to improve recovery quality and patient satisfaction after surgery and explore broader applications for PONV prevention. Participants are randomly assigned to receive either a dual-chamber PCA delivering both fentanyl and ketorolac or a single-chamber PCA delivering only fentanyl after surgery. These devices allow intravenous patient-controlled analgesia to manage postoperative pain. The trial is a prospective, randomized controlled study with quadruple masking to compare recovery outcomes between the two PCA methods. During the study, female patients aged 19 to 65 who undergo laparoscopic sleeve gastrectomy will be monitored for postoperative nausea and vomiting within the first day after surgery. Researchers will assess pain control, opioid use, and side effects. Safety monitoring includes tracking adverse reactions to medications, and participants' recovery progress is observed throughout the postoperative period. The total participation time aligns with the immediate recovery phase after surgery.

CONDITIONS

Brief Title

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

Who Can Participate

Age: 19Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult females aged 19 to 65 years
  • American Society of Anesthesiologists physical status (ASA class) 1 to 3
  • Scheduled for laparoscopic sleeve gastrectomy under general anesthesia
  • Requesting the use of intravenous patient-controlled analgesia after surgery
Not Eligible

You will not qualify if you...

  • Hypersensitivity to ketorolac or fentanyl
  • Alcohol or drug dependence, long-term opioid or analgesic use
  • Liver disease or renal failure
  • Peptic ulcer or gastrointestinal bleeding risk
  • Suspected cerebrovascular hemorrhage or head disorders with increased intracranial pressure
  • Bronchial asthma or bronchospasm symptoms
  • Severe respiratory depression
  • Nasal polyps or angioedema
  • History of convulsive disease
  • Contraindication to neuromuscular blocking agents

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Postoperative period (up to 1 day)

Participants receive either a dual-chamber patient-controlled analgesia device delivering fentanyl and ketorolac or a single regimen delivering fentanyl only after laparoscopic sleeve gastrectomy to manage postoperative pain and reduce nausea and vomiting.

1 postoperative visit (in-person)

Post-operative Follow-up

Duration - Up to 1 day after surgery

Participants are monitored for recovery quality, postoperative nausea, and vomiting after the analgesia intervention.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Seoul National University Bundang Hospital

Seongnam-si, Gyunggi-do, South Korea, 13620

Actively Recruiting

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Research Team

I

Insun Park, M.D./Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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