Bellomic PCA in Laparoscopic Gynecologic Surgery

Seoul National University

Status: Completed

Conditions: Laparoscopic Gynecological Surgery

Treatments: Drug: Ketorolac continuous; Drug: Fentanyl continuous; Drug: Fentanyl selector

Study type: Interventional

Funder types: Other

Identifiers

NCT05489796

B-2110-716-003

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups

Dual group

Experimental group

Description:

The two drugs are administered separately.

Treatment:

Drug: Ketorolac continuous

Drug: Fentanyl selector

Single group

Active Comparator group

Description:

One drug is administered alone.

Treatment:

Drug: Fentanyl continuous

Drug: Fentanyl selector