Epidural PCA Related Adverse Effects in Young and Elderly

Sponsor

Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02849730

Collaborator

(none)

2,435

Enrollment

Location

Duration (Months)

805.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	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 Design

Study Type:

Observational

Actual Enrollment :

2435 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	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

Arm

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

Other Names:

Epidural patient controlled analgesic device

Outcome Measures

Primary Outcome Measures

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
Incidence of discontinuation of Epi-PCA [Postoperative up to 48 hours]
The percentage of patients who discontinued Epi-PCA

Secondary Outcome Measures

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