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Epidural PCA Related Adverse Effects in Young and Elderly

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ClinicalTrials.gov Identifier: NCT02849730
Recruitment Status : Completed
First Posted : July 29, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Koh, Jae Chul, MD, Severance Hospital

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
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.


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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 : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Epidural patient controlled analgesic device




Primary Outcome Measures :
  1. Incidence of Rescue Analgesics Requirement [ Time Frame: Postoperative up to 48 hours ]
    The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period

  2. Incidence of discontinuation of Epi-PCA [ Time Frame: Postoperative up to 48 hours ]
    The percentage of patients who discontinued Epi-PCA


Secondary Outcome Measures :
  1. Postoperative Pain in Numeric Pain Scale [ Time Frame: 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)

  2. Incidence of Nausea and Vomiting [ Time Frame: Postoperative 48 hours ]
    The percentage of participants who had nausea and vomiting during postoperative 48 hours

  3. Incidence of Dizziness or Headaches [ Time Frame: Postoperative up to 48 hours ]
    The percentage of participants who had headache and dizziness during postoperative 48 hours



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849730


Locations
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Korea, Republic of
Gangnam Severance hospital
Seoul, Gangnam-gu, Korea, Republic of, 135-720
Sponsors and Collaborators
Severance Hospital
Investigators
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Study Chair: Dong Woo Han, MD, PhD Gang Nam Severance Hospitial

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Responsible Party: Dr. Koh, Jae Chul, MD, Assistant professor, Department of Anesthesiology and Pain medicine, Severance Hospital
ClinicalTrials.gov Identifier: NCT02849730     History of Changes
Other Study ID Numbers: 2016-0295-001
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Koh, Jae Chul, MD, Severance Hospital:
Epi-PCA
Patient controlled analgesia
Epidural patient controlled analgesia
Elderly patient
Side effect
Postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local