Epidural PCA Related Adverse Effects in Young and Elderly

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: Fentanyl/ropivacaine based Epi-PCA

• Registration Number: NCT02849730
• Lead Sponsor: Severance Hospital

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.

Detailed Description

Since 2010, A PCA service team in the investigators' hospital have collected multidisciplinary clinical data from all the patients who used epidural-patient controlled analgesia (Epi-PCA) postoperatively in aim of the assessment of clinical outcome. The investigators reviewed the 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. The need for informed consent was waived for this study. For the Epi-PCA, fentanyl and ropivacaine was diluted and administered to the patients according to the clinician's determination.

The data of the PCA regimen which has been decided were recorded and analyzed. Demographic variables including age, sex, body mass index, American Society of Anesthesiologists (ASA) physical status and history of smoking, motion sickness, postoperative nausea/vomiting, hypertension and diabetes mellitus will be analyzed. Anesthesia and surgery-related variables including the duration of anesthesia, the type of anesthesia (general or spinal), laparoscopy and the operation site (categorized in abdominal, thoracic, upper \& lower extremities, head \& neck, spine and others) will be also analyzed. PCA-related variables including total dose of fentanyl for two days (µg/kg), use of mixed additional analgesics and antiemetics in PCA and discontinuation of PCA will be analyzed. Postoperative variables including the numeric rating scale (NRS, 0-10, 0 = no symptom; 10= unthinkable worst pain) for pain, requirements of rescue analgesics and antiemetics will be analyzed. In addition, the postoperative complications including nausea, vomiting, headache, dizziness, and sedation will be analyzed. All the recorded postoperative variables at post-anesthesia care unit, 6-12, 12-18, 18-24 and 24-48 hrs after anesthesia will be analyzed.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-07-29
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2435

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young adults	Fentanyl/ropivacaine based Epi-PCA	Patients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.
Elderly patients	Fentanyl/ropivacaine based Epi-PCA	Patients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.

Primary Outcome Measures

Name	Time	Method
Incidence of discontinuation of Epi-PCA	Postoperative up to 48 hours	The percentage of patients who discontinued Epi-PCA
Incidence of Rescue Analgesics Requirement	Postoperative up to 48 hours	The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain in Numeric Pain Scale	Postoperative up to 48 hours	The Numeric Pain Scale (NRS - 0: no pain, 10: worst pain can't imagine) for pain measured once at each time periods (0\~6, 6\~12, 12\~18, 18\~24, 24\~48 hours)
Incidence of Nausea and Vomiting	Postoperative 48 hours	The percentage of participants who had nausea and vomiting during postoperative 48 hours
Incidence of Dizziness or Headaches	Postoperative up to 48 hours	The percentage of participants who had headache and dizziness during postoperative 48 hours

Trial Locations

Locations (1)

Gangnam Severance hospital; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of