Bellomic PCA in Laparoscopic Gynecologic Surgery

NCT05489796 | Completed

• 1 other identifier: B-2110-716-003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Gynecological Surgery

Outcome Measures

Primary Outcomes (2)

• Change in the occurrence of postoperative nausea

  Confirm the occurrence of postoperative nausea.

  postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

• Change in the occurrence of postoperative vomiting

  Confirm the occurrence of postoperative vomiting.

  postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour

Secondary Outcomes (3)

• 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

Study Arms (2)

Dual group

EXPERIMENTAL

The two drugs are administered separately.

Drug: Fentanyl selector; Drug: Ketorolac continuous

Single group

ACTIVE COMPARATOR

One drug is administered alone.

Drug: Fentanyl selector; Drug: Fentanyl continuous

Interventions

Fentanyl selector DRUG

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

Dual group; Single group

Fentanyl continuous DRUG

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

Single group

Ketorolac continuous DRUG

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

Dual group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: August 5, 2022
• Study Start: June 30, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

KR (1)