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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07051109

Enrollment

Registered

2025-07-03

Start date

2022-10-11

Completion date

2026-03-11

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Morbid Obesity, PCA, PONV

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
postoperative nausea and vomitting	postoperative 1 day	The Quality of Recovery score 15

Countries

South Korea

Contacts

Primary ContactInsun Park, M.D./Ph.D.

pis121@hanmail.net823178777499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026