Clinical trial NCT02849730: Epidural PCA Related Adverse Effects in Young and Elderly
Official title: Postoperative Pain and Patient-controlled Epidural Analgesia Related Adverse Effects in Young and Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Epi-PCA
Patient controlled analgesia
Epidural patient controlled analgesia
Elderly patient
Side effect
Postoperative pain
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 2435
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Incidence of Rescue Analgesics Requirement
timeFrame: Postoperative up to 48 hours
measure: Incidence of discontinuation of Epi-PCA
timeFrame: Postoperative up to 48 hours
Secondary outcomes:
measure: Postoperative Pain in Numeric Pain Scale
timeFrame: Postoperative up to 48 hours
measure: Incidence of Nausea and Vomiting
timeFrame: Postoperative 48 hours
measure: Incidence of Dizziness or Headaches
timeFrame: Postoperative up to 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
state: Gangnam-gu
Study officials:
affiliation: Gang Nam Severance Hospitial
name: Dong Woo Han, MD, PhD
role: STUDY_CHAIR
References: