Dual-chamber Patient-controlled Analgesia for Postoperative Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2026-03-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Intravenous Patient-controlled Analgesia (IV-PCA) With Fentanyl in Adults for Acute Postoperative Pain Control

NCT01527890

Nausea Vomiting

UNKNOWN

The Effect of PCA on PONV After Microvascular Decompression

NCT05189704

Postoperative Nausea and Vomiting

UNKNOWN NA

Effect of Opioid-free Analgesia and Anesthesia on the Quality of Postoperative Recovery and Nausea Vomit in Patients Receiving Laparoscopic Sleeve Gastrectomy

NCT06305221

Opioid-Free Anesthesia Laparoscopic Sleeve Gastrectomy Postoperative Vomiting +1 more

RECRUITING NA

Bellomic PCA in Laparoscopic Gynecologic Surgery

NCT05489796

Laparoscopic Gynecological Surgery

COMPLETED NA

Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -

NCT01863355

The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Morbid Obesity PCA Analgesia PONV

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dual-chamber PCA

Group Type EXPERIMENTAL

multimodal analgesia via dual-chamber PCA

Intervention Type DEVICE

combination of fentanyl and ketorolac through dual-chamber PCA

single regimen PCA

Group Type ACTIVE_COMPARATOR

single regimen (only fentanyl)

Intervention Type DEVICE

fentanyl only through dual-chamber PCA

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

multimodal analgesia via dual-chamber PCA

combination of fentanyl and ketorolac through dual-chamber PCA

Intervention Type DEVICE

single regimen (only fentanyl)

fentanyl only through dual-chamber PCA

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No