Pain, PostoperativeNCT02849730
Epidural PCA Related Adverse Effects in Young and Elderly
An observational study of Pain, Postoperative, run by Severance Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fentanyl/ropivacaine based Epi-PCA
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2,435 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015.
Who cannot join
- Age < 20 years old,
- Age 40 to 69,
- Routine use of analgesics/antiemetics
- Imperfect data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain and Patient-controlled Epidural Analgesia Related Adverse Effects in Young and Elderly Patients
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Fentanyl/ropivacaine based Epi-PCA
- Keywords
- Epi-PCA, Patient controlled analgesia, Epidural patient controlled analgesia, Elderly patient, Side effect, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl/ropivacaine based Epi-PCADevice
Also called Epidural patient controlled analgesic 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.
| Study group | Role | What they receive |
|---|---|---|
| Young adults | Patients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. Receives: Device: Fentanyl/ropivacaine based Epi-PCA | |
| Elderly patients | Patients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. Receives: Device: Fentanyl/ropivacaine based Epi-PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Rescue Analgesics Requirement
The percentage of patients who required rescue analgesics at least once during the postoperative 48-hour period
Measured: Postoperative up to 48 hours
Incidence of discontinuation of Epi-PCA
The percentage of patients who discontinued Epi-PCA
Measured: Postoperative up to 48 hours
Secondary outcomes (3)
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)
Measured: Postoperative up to 48 hours
Incidence of Nausea and Vomiting
The percentage of participants who had nausea and vomiting during postoperative 48 hours
Measured: Postoperative 48 hours
Incidence of Dizziness or Headaches
The percentage of participants who had headache and dizziness during postoperative 48 hours
Measured: Postoperative up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Koh, Jae Chul, MD, Severance Hospital
- Investigators
- Dong Woo Han, MD, PhD, Study chair, Gang Nam Severance Hospitial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849730
- Sponsor's protocol ID
- 2016-0295-001
- Status last verified
- Oct 2016
- First submitted
- 27 Jul 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Patient-controlled Epidural Analgesia Related Adverse Effects in Young and Elderly Patients
- ClinicalTrials.gov ID
- NCT02849730
- Acronym / sponsor ID
- 2016-0295-001
- Conditions
- Pain, Postoperative
- Keywords
- Epi-PCA, Patient controlled analgesia, Epidural patient controlled analgesia, Elderly patient, Side effect, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,435 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young adults | – | Device: Fentanyl/ropivacaine based Epi-PCAPatients aged 20 to 39 who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. |
| Elderly patients | – | Device: Fentanyl/ropivacaine based Epi-PCAPatients aged 70 and over who had used fentanyl/ropivacaine based Epi-PCA for postoperative pain. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who had used Epi-PCA for pain control after an elective surgery under general or spinal anesthesia between Sep. 2010 and Nov. 2015.
Key exclusion criteria (4 listed)
- Age < 20 years old,
- Age 40 to 69,
- Routine use of analgesics/antiemetics
- Imperfect data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl/ropivacaine based Epi-PCAAlso: Epidural patient controlled analgesic deviceFentanyl 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. | Device | Elderly patients, Young adults |
Primary outcome
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
Incidence of discontinuation of Epi-PCA
Time frame: Postoperative up to 48 hours
The percentage of patients who discontinued Epi-PCA
3 secondary outcomes
Postoperative Pain in Numeric Pain Scale
Time frame: Postoperative up to 48 hours
Incidence of Nausea and Vomiting
Time frame: Postoperative 48 hours
Incidence of Dizziness or Headaches
Time frame: Postoperative up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Woo Han, MD, PhD study chair
Gang Nam Severance Hospitial
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Rescue Analgesics Requirement (time frame: Postoperative up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.