Postoperative PainNCT02331576
Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics in Femoral Nerve Block
A study testing rocaine and Fentanyl in people with Postoperative Pain, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- rocaine and Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who scheduled to receive knee arthroplasty with general anesthesia
- ASA physical status 1 or 2
Who cannot join
- allergy to drug
- refuse to the study
- ASA physical status 3 and 4
- history of drug abuse
- cognitive disfunction such as dementia
- patients who do not adequate for general anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-763
Bongha Heo, Dr, 082-010-9432-7126, bongha99@naver.com
About this study
Official title: Femoral Nerve Block in Patient With Total Knee Arthroplasty; Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics
The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty.
- Conditions
- Postoperative Pain
- Being tested
- rocaine, Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocaineDrug
Also called ropivacaine HCL
FentanylDrug
Also called fentanyl citrate
| Study group | Role | What they receive |
|---|---|---|
| rocaine | Placebo comparator | continuous femoral nerve block with ropivacaine alone. Receives: Drug: rocaine |
| rocaine with fentanyl | Active comparator | continuous femoral nerve block with combination of ropivacaine and fentanyl. Receives: Drug: rocaine; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Visual Analogue Scales by time sequence
Measured: baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BHeo, Chonnam National University Hospital
- Investigators
- Bongha Heo, Dr, Principal investigator, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331576
- Sponsor's protocol ID
- CNUHH-2014-141
- Status last verified
- Jul 2016
- First submitted
- 23 Dec 2014
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Nerve Block in Patient With Total Knee Arthroplasty; Analgesic Effect of Perineural Fentanyl Additive to Local Anesthetics
- ClinicalTrials.gov ID
- NCT02331576
- Acronym / sponsor ID
- CNUHH-2014-141
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 2015 (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.
The purpose of this study is to evaluate the analgesic efficacy of perineural fentanyl combined with local anesthetics in the post operative pain control with continuous femoral nerve block after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rocaine | Placebo comparator | Drug: rocainecontinuous femoral nerve block with ropivacaine alone. |
| rocaine with fentanyl | Active comparator | Drug: rocaine, Drug: Fentanylcontinuous femoral nerve block with combination of ropivacaine and fentanyl. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who scheduled to receive knee arthroplasty with general anesthesia
- ASA physical status 1 or 2
Key exclusion criteria (6 listed)
- allergy to drug
- refuse to the study
- ASA physical status 3 and 4
- history of drug abuse
- cognitive disfunction such as dementia
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 |
|---|---|---|
| rocaineAlso: ropivacaine HCL | Drug | rocaine, rocaine with fentanyl |
| FentanylAlso: fentanyl citrate | Drug | rocaine with fentanyl |
Primary outcome
Change from baseline in Visual Analogue Scales by time sequence
Time frame: baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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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.
Bongha Heo, Dr principal investigator
assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rocaine and Fentanyl in people with Postoperative Pain, run by Chonnam National University 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Jul 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bongha Heo, Dr. (082-010-9432-7126, bongha99@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Visual Analogue Scales by time sequence (time frame: baseline(just after operation), 15, 30, 60 minute and 24 hour after intervention). 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 Jul 2016.