Bellomic PCA in Laparoscopic Gynecologic Surgery

Laparoscopic Gynecological Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489796
• Other study ID #: B-2110-716-003
• Status: Completed
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2023
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Gynecological Surgery

Intervention

Drug:
• Fentanyl selector
Selector (1 ml; Lock out 10 min): Fentanyl 200 mcg + N/S 16 ml = total 20 ml
• Fentanyl continuous
Continuous (2 ml/hr): fentanyl 700 mcg + N/S 86 ml = total 100 ml
• Ketorolac continuous
Continuous (2 ml/hr): Ketorolac 180 mg + N/S 94 ml = total 100 ml

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the occurrence of postoperative nausea	Confirm the occurrence of postoperative nausea.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Primary	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	Change in the use of rescue antiemetics	Investigate the use of rescue antiemetics.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Secondary	Change of postoperative pain score	Postoperative pain scores are scored on a scale of 0-10.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour
Secondary	Change in the use of rescue analgesics	Investigate the use of rescue analgesics.	postoperative 0 hour, 2 hour, 6 hour, 12 hour, 24 hour