Bellomic PCA in Laparoscopic Gynecologic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Laparoscopic Gynecological Surgery

Intervention / Treatment
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* Drug: Fentanyl selector
* Drug: Fentanyl continuous
* Drug: Ketorolac continuous


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |