Epidural PCA Related Adverse Effects in Young and Elderly

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Device: Fentanyl/ropivacaine based Epi-PCA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Young adults<br>Patients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. | Device: Fentanyl/ropivacaine based Epi-PCA<br>* 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.<br>* Other names: Epidural patient controlled analgesic device;|
| Elderly patients<br>Patients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. | Device: Fentanyl/ropivacaine based Epi-PCA<br>* 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.<br>* Other names: Epidural patient controlled analgesic device;|

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 Nausea and Vomiting | The percentage of participants who had nausea and vomiting during postoperative 48 hours | Postoperative 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epi-PCA, Patient controlled analgesia, Epidural patient controlled analgesia, Elderly patient, Side effect, Postoperative pain