NCT02448862

Brief Summary

In this retrospective study, postoperative pain score, PCA-related complications, the risk factors for requirement of rescue analgesics and antiemetics will be evaluated in young and elderly patients, respectively, using fentanyl-based IV 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
10,575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

May 14, 2015

Results QC Date

October 3, 2015

Last Update Submit

April 18, 2016

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Keywords

IV-PCAElderly patientsYound adultsSide effectPostoperative painPostoperative nausea and vomiting

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 48 hours

  • Incidence of Rescue Antiemetics Requirement

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

    Postoperative 48 hours

Secondary Outcomes (3)

  • Postoperative Pain in Numeric Pain Scale

    Postoperative 48 hours

  • Incidence of Nausea and Vomiting

    Postoperative 48 hours

  • Incidence of Dizziness or Headaches

    Postoperative 48 hours

Study Arms (2)

Elderly patients

Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.

Device: Fentanyl based IV-PCA

Young adults

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

Device: Fentanyl based IV-PCA

Interventions

Fentanyl based IV-PCADEVICE

We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs.

Also known as: Intravenous 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 IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014.

You may qualify if:

  • Patients who had used IV-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and March. 2014

You may not qualify if:

  • Age \< 20 years old,
  • age 40 to 69,
  • postoperative ventilator support or intensive care,
  • and 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

Related Publications (2)

  • Choi JB, Shim YH, Lee YW, Lee JS, Choi JR, Chang CH. Incidence and risk factors of postoperative nausea and vomiting in patients with fentanyl-based intravenous patient-controlled analgesia and single antiemetic prophylaxis. Yonsei Med J. 2014 Sep;55(5):1430-5. doi: 10.3349/ymj.2014.55.5.1430.

    PMID: 25048507BACKGROUND

  • Mortimer M, Ahlberg G; MUSIC-Norrtalje Study Group. To seek or not to seek? Care-seeking behaviour among people with low-back pain. Scand J Public Health. 2003;31(3):194-203. doi: 10.1080/14034940210134086.

    PMID: 12850973BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Results Point of Contact

Title
Dr. Jae Chul Koh, MD
Organization
Gangnam Severance hospital, Seoul, Korea
aneskoh@yuhs.ac
82-01087023931

Study Officials

  • Jae Chul Koh, MD

    Gang Nam Severance Hospitial

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology and pain medicine

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 20, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 2, 2016

Results First Posted

May 2, 2016

Record last verified: 2016-04

Locations

KR(1)