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NCT Number: NCT02849730

Epidural PCA Related Adverse Effects in Young and Elderly

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gangnam Severance hospital

Seoul, Gangnam-gu, 135-720, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl/ropivacaine based Epi-PCA

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.

Other names: Epidural patient controlled analgesic device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2016
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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