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

Sponsors

Lead Sponsor: Seoul National University Bundang Hospital

Source 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.
Overall Status Recruiting
Start Date 2022-06-30
Completion Date 2023-06-01
Primary Completion Date 2023-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in the occurrence of postoperative nausea postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the occurrence of postoperative vomiting postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Secondary Outcome
Measure Time Frame
Change in the use of rescue antiemetics postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change of postoperative pain score postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Change in the use of rescue analgesics postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Enrollment 72
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fentanyl selector

Description: Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml

Intervention Type: Drug

Intervention Name: Fentanyl continuous

Description: Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml

Arm Group Label: Single group

Intervention Type: Drug

Intervention Name: Ketorolac continuous

Description: Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml

Arm Group Label: Dual group

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

20 Years

Maximum Age:

65 Years

Healthy Volunteers:

No
Overall Contact

Last Name: Hyo-Seok Na

Phone: 82317877507

Email: [email protected]

Location
Facility: Status: Contact: Seoul National Univ. Bundang Hospital Hyo-Seok Na 1087012913 [email protected]
Location Countries

Korea, Republic of
Verification Date

2022-08-01
Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Bundang Hospital

Investigator Full Name: Hyo-Seok Na

Investigator Title: Principal Investigator

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Dual group

Type: Experimental

Description: The two drugs are administered separately.

Label: Single group

Type: Active Comparator

Description: One drug is administered alone.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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