Epidural PCA Related Adverse Effects in Young and Elderly

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849730
• Other study ID #: 2016-0295-001
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: October 26, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2435
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance hospital	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Incidence of discontinuation of Epi-PCA	The percentage of patients who discontinued Epi-PCA	Postoperative up to 48 hours	No
Secondary	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	No
Secondary	Incidence of Nausea and Vomiting	The percentage of participants who had nausea and vomiting during postoperative 48 hours	Postoperative 48 hours	No
Secondary	Incidence of Dizziness or Headaches	The percentage of participants who had headache and dizziness during postoperative 48 hours	Postoperative up to 48 hours	No