Epidural PCA Related Adverse Effects in Young and Elderly

Postoperative Pain and Patient-controlled Epidural Analgesia Related Adverse Effects in Young and Elderly Patients

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Device: Fentanyl/ropivacaine based Epi-PCA

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 Type: Observational
• Enrollment (Actual): 2435

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 135-720
      • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young adults; Patients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.	Device: Fentanyl/ropivacaine based Epi-PCA; 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.; Other Names: Epidural patient controlled analgesic device
Elderly patients; Patients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain.	Device: Fentanyl/ropivacaine based Epi-PCA; 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.; Other Names: Epidural patient controlled analgesic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Nausea and Vomiting	The percentage of participants who had nausea and vomiting during postoperative 48 hours	Postoperative 48 hours
Postoperative Pain in Numeric Pain Scale	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)	Postoperative up to 48 hours
Incidence of Dizziness or Headaches	The percentage of participants who had headache and dizziness during postoperative 48 hours	Postoperative up to 48 hours

Collaborators and Investigators

• Sponsor: Severance Hospital
• Investigators: Study Chair: Dong Woo Han, MD, PhD, Gang Nam Severance Hospitial

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Postoperative pain; Patient controlled analgesia; Side effect; Elderly patient; Epi-PCA; Epidural patient controlled analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ropivacaine; Analgesics
• Other Study ID Numbers: 2016-0295-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO