The Effect of PCA on PONV After Microvascular Decompression

April 12, 2023 updated by: Chang-Hoon Koo, Seoul National University Hospital

The Effect of Patient-controlled Analgesia (Ketorolac vs. Fentanyl) on the Development of Postoperative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: a Prospective Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSAID group
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Drug: NSAID
NSAID based patient-controlled analgesia will connected to intravenous line for pain control.
Active Comparator: Opioid group
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.
Drug: Opioid
Opioid based patient-controlled analgesia will connected to intravenous line for pain control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: postoperative 48 hours
Incidence
postoperative 48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Chang-Hoon Koo, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Actual)

February 15, 2023

Study Completion (Anticipated)

August 31, 2023

Study Registration Dates

First Submitted

December 7, 2021

First Submitted That Met QC Criteria

December 30, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVD-PCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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