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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05489796

Enrollment

Registered

2022-08-05

Start date

2022-06-30

Completion date

2022-08-31

Last updated

2023-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecological Surgery

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.

Interventions

DRUGFentanyl selector

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

DRUGFentanyl continuous

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

DRUGKetorolac continuous

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026