The Effect of PCA on PONV After Microvascular Decompression

Not Applicable

Recruiting

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: NSAID; Drug: Opioid

• Registration Number: NCT05189704
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-07
• Study Start: 2021-12-20
• Study First Submitted QC: 2021-12-30
• Study First Posted: 2022-01-12
• Primary Completion: 2023-02-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patients who undergo elective microvascular decompression surgery
• American Society of Anesthesiologists grade 1 or 2
• 19 - 65 years old

Exclusion Criteria

• Refuse to participate to the study
• Refuse to use Patient-controlled analgesia
• Body Mass Index < 18.5 kg/m2 or > 35 kg/m2
• history of craniotomy or chemotheraphy
• Patients who used preoperative antiemetics within 24h before surgery
• Severe renal or hepatic dysfunction
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAID group	NSAID	NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Opioid group	Opioid	Opioid based patient-controlled analgesia will connected to intravenous line for pain control.

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting	postoperative 48 hours	Incidence

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours	pain intensity will be assessed using numeric rating scale (0=none, 10=worst pain possible)
Rescue antiemetics requirement	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Rescue analgesic requirement	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Satisfaction score for postoperative nausea and vomiting	postoperative 48 hours	using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)
Postoperative nausea and vomiting	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours	Severity accessed using numeric rating scale (0=none, 10=worst PONV possible)
Postoperative PCA consumption	Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
Satisfaction score for postoperative pain	postoperative 48 hours	using 11-point scale (0=Worst dissatisfied, 10=Very satisfied)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of