Bellomic PCA in Laparoscopic Gynecologic Surgery

NCT ID: NCT05489796

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2022-08-31

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.

Detailed Description

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Conditions

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Laparoscopic Gynecological Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dual group

The two drugs are administered separately.

Group Type EXPERIMENTAL

Fentanyl selector

Intervention Type DRUG

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

Ketorolac continuous

Intervention Type DRUG

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

Single group

One drug is administered alone.

Group Type ACTIVE_COMPARATOR

Fentanyl selector

Intervention Type DRUG

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

Fentanyl continuous

Intervention Type DRUG

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

Interventions

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Fentanyl selector

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

Intervention Type DRUG

Fentanyl continuous

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

Intervention Type DRUG

Ketorolac continuous

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

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-2110-716-003

Identifier Type: -

Identifier Source: org_study_id

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