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RecruitingNCT07051109Updated Jul 3, 2025

Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

An interventional study of multimodal analgesia via dual-chamber PCA and single regimen (only fentanyl) in Morbid Obesity, PCA and Analgesia, sponsored by Seoul National University Bundang Hospital. Recruiting at 1 site in South Korea. Open to female participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 2 years 3 months after the study started (first participant enrolled Oct 2022, registered Jan 2025).
  • Started Oct 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Morbid Obesity
  • PCA
  • Analgesia
  • PONV
03

In context

Obesity, Morbid

922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.

This study's planned enrollment of 92 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    dual-chamber PCA

    Device: multimodal analgesia via dual-chamber PCA

  • Active comparator
    single regimen PCA

    Device: single regimen (only fentanyl)

Interventions

  • Devicemultimodal analgesia via dual-chamber PCA

    combination of fentanyl and ketorolac through dual-chamber PCA

  • Devicesingle regimen (only fentanyl)

    fentanyl only through dual-chamber PCA

06

What researchers measure

Primary outcomes

  1. postoperative nausea and vomitting

    The Quality of Recovery score 15

    Time frame: postoperative 1 day

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyunggi-do 13620, South Korea
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07051109
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Park InSun (Principal investigator, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jul 3, 2025
Start date
Oct 11, 2022
Primary completion
Aug 11, 2025 (estimated)
Completion
Mar 11, 2026 (estimated)
Last update
Jul 3, 2025

Study contacts

Insun Park, M.D./Ph.D.
Contact
pis121@hanmail.net
823178777499

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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