Epidural PCA Related Adverse Effects in Young and Elderly

NCT ID: NCT02849730

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2435 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2016-10-31

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.

Conditions

Pain, Postoperative

Keywords

Epi-PCA; Patient controlled analgesia; Epidural patient controlled analgesia; Elderly patient; Side effect; Postoperative pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Young adults

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

Fentanyl/ropivacaine based Epi-PCA

Intervention Type: DEVICE

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.

Elderly patients

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

Fentanyl/ropivacaine based Epi-PCA

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Epidural patient controlled analgesic device

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Koh, Jae Chul, MD

Assistant professor, Department of Anesthesiology and Pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Woo Han, MD, PhD

Role: STUDY_CHAIR

Gang Nam Severance Hospitial

Locations

Gangnam Severance hospital

Seoul, Gangnam-gu, South Korea

Countries

South Korea

Other Identifiers

2016-0295-001

Identifier Type: -

Identifier Source: org_study_id