Bellomic PCA in Laparoscopic Gynecologic Surgery

Not Applicable

Completed

• Conditions: Laparoscopic Gynecological Surgery
• Interventions: Drug: Fentanyl selector; Drug: Fentanyl continuous; Drug: Ketorolac continuous

• Registration Number: NCT05489796
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

In laparoscopic gynecological surgery, when intravenous patient-controlled analgesia (IV-PCA) device is used after surgery, the degree of postoperative side effects and pain control is compared when a combination of fentanyl and ketorolac is administered compared to when fentanyl alone is used.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-30
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• American society of anesthesiology physical status 1 or 2
• Patients scheduled for gynecological laparoscopic surgery under general anesthesia
• Patients who applied for the use of IV-PCA after surgery

Exclusion Criteria

• Patients with side effects of opioids
• Patients with hypersensitivity to aspirin or non-steroid anti-inflammatory drugs
• Patients with alcohol or drug dependence
• Patients with peptic ulcers, patients with gastrointestinal bleeding
• Patients with suspected cerebrovascular hemorrhage, organic disorders, or damage to the head related to increased intracranial pressure
• Symptoms of bronchial asthma or bronchospasm
• Patients with severe respiratory depression
• Moderate to severe renal impairment
• Patients with reduced blood volume or dehydration
• polyps in the nose
• angioedema
• Patients with or a history of the convulsive disease
• Patients for whom the use of neuromuscular blocking agents is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual group	Fentanyl selector	The two drugs are administered separately.
Single group	Fentanyl selector	One drug is administered alone.
Single group	Fentanyl continuous	One drug is administered alone.
Dual group	Ketorolac continuous	The two drugs are administered separately.

Primary Outcome Measures

Name	Time	Method
Change in the occurrence of postoperative nausea	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour	Confirm the occurrence of postoperative nausea.
Change in the occurrence of postoperative vomiting	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour	Confirm the occurrence of postoperative vomiting.

Secondary Outcome Measures

Name	Time	Method
Change in the use of rescue antiemetics	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour	Investigate the use of rescue antiemetics.
Change of postoperative pain score	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour	Postoperative pain scores are scored on a scale of 0-10.
Change in the use of rescue analgesics	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour	Investigate the use of rescue analgesics.

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of