NCT02849730

Brief Summary

In this retrospective study, postoperative pain score, epidural patient controlled analgesia (Epi-PCA) related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl and ropivacaine-based Epi-PCA during postoperative 48 hours after various surgeries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,435

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

July 27, 2016

Last Update Submit

October 26, 2016

Conditions

Pain, Postoperative

Keywords

Epi-PCAPatient controlled analgesiaEpidural patient controlled analgesiaElderly patientSide effectPostoperative pain

Outcome Measures

Primary Outcomes (2)

  • Incidence of Rescue Analgesics Requirement

    The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period

    Postoperative up to 48 hours

  • Incidence of discontinuation of Epi-PCA

    The percentage of patients who discontinued Epi-PCA

    Postoperative up to 48 hours

Secondary Outcomes (3)

  • Postoperative Pain in Numeric Pain Scale

    Postoperative up to 48 hours

  • Incidence of Nausea and Vomiting

    Postoperative 48 hours

  • Incidence of Dizziness or Headaches

    Postoperative up to 48 hours

Study Arms (2)

Young adults

Patients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.

Device: Fentanyl/ropivacaine based Epi-PCA

Elderly patients

Patients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.

Device: Fentanyl/ropivacaine based Epi-PCA

Interventions

Fentanyl/ropivacaine based Epi-PCADEVICE

Fentanyl and ropivacaine was diluted and administered to the patients according to the clinician's determination. The clinician decided dose, infusion rate, bolus dose, lockout time and total amount of drug mixed in the Epi-PCA.

Also known as: Epidural patient controlled analgesic device
Elderly patientsYoung adults

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Collected data from the patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015.

You may qualify if:

  • Patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015.

You may not qualify if:

  • Age \< 20 years old,
  • Age 40 to 69,
  • Routine use of analgesics/antiemetics
  • Imperfect data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gangnam Severance hospital

Seoul, Gangnam-gu, 135-720, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Dong Woo Han, MD, PhD

    Gang Nam Severance Hospitial

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Department of Anesthesiology and Pain medicine

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)