Bellomic PCA in Laparoscopic Gynecologic Surgery

Comparison of Postoperative Side Effects and Analgesic Quality According to the Combination of Fentanyl and Ketorolac Versus Fentanyl After Laparoscopic Gynecologic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Gynecological Surgery
• Intervention / Treatment: Drug: Fentanyl selector; Drug: Ketorolac continuous; Drug: Fentanyl continuous

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyo-Seok Na; Phone Number: 871087012913; Email: hsknana@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Seongnam, Gyeonggi, Korea, Republic of, 463-707
      • Seoul National Univ. Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual group; The two drugs are administered separately.	Drug: Fentanyl selector; Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml; Drug: Ketorolac continuous; Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml
Active Comparator: Single group; One drug is administered alone.	Drug: Fentanyl selector; Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml; Drug: Fentanyl continuous; Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the occurrence of postoperative nausea	Confirm the occurrence of postoperative nausea.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the occurrence of postoperative vomiting	Confirm the occurrence of postoperative vomiting.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Ketorolac
• Other Study ID Numbers: B-2110-716-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No