Bellomic PCA in Laparoscopic Gynecologic Surgery

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05489796

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopic Gynecological Surgery	Drug: Fentanyl selector Drug: Fentanyl continuous Drug: Ketorolac continuous	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	463-707

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo-Seok Na, Principal Investigator, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT05489796

Other Study ID Numbers:

B-2110-716-003

First Posted:

Aug 5, 2022

Last Update Posted:

Aug 5, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ketorolac

Fentanyl

Study Results

No Results Posted as of Aug 5, 2022