PainNCT02501863
Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty
A study testing Femoral nerve block with ropivacaine+fentanyl and Femoral nerve block with ropivacaine in people with Pain, run by National Medical Center, Seoul.
Trial summary
The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Femoral nerve block with ropivacaine+fentanyl and Femoral nerve block with ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Aug 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia
Who cannot join
- Patients were excluded from this study if they had contraindications to a regional anesthetic technique (e. g., local infection, sepsis, coagulation abnormality), allergy to local anesthetic or fentanyl, preexisting neurologic deficit in the lower extremities, and inability to comprehend the pain scales or use IV patient-controlled analgesia (PCA) device.
About this study
The postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.
Read the detailed description
Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two groups (R, "3-in-1" using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after operation and satisfaction will be compared.
- Conditions
- Pain
- Being tested
- Femoral nerve block with ropivacaine+fentanyl, Femoral nerve block with ropivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve block with ropivacaine+fentanylDrug
Also called RF
Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
Femoral nerve block with ropivacaineDrug
Also called R
Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine+fentanyl | Experimental | Femoral nerve block with ropivacaine+fentanyl
Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. Receives: Drug: Femoral nerve block with ropivacaine+fentanyl |
| Ropivacaine | Experimental | Femoral nerve block with ropivacaine
Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. Receives: Drug: Femoral nerve block with ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on the VAS(Visual Analog Scale)
VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day.
Measured: During 48 hour after operation
Secondary outcomes (1)
Number of participant with side effects
Measured: During 48 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Center, Seoul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mija Yun, MD, PhD, National Medical Center, Seoul
- Investigators
- Mijung Yun, MD, PhD, Principal investigator, National medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501863
- Sponsor's protocol ID
- AN1
- Status last verified
- Sep 2016
- First submitted
- 15 Jul 2015
- Last updated
- 14 Sep 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 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Ropivacaine Plus Fentanyl vs Ropivacaine for Continuous 3-in-1 FNB After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02501863
- Acronym / sponsor ID
- AN1
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Medical Center, SeoulUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jul 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 postoperative analgesic effect of the continuous 3-in-1 femoral nerve block (FNB) with ropivacaine/fentanyl or with ropivacaine were compared in total knee arthroplasty.
Detailed description
Forty patients of American Society of Anesthesiologist physical status Ⅰor Ⅱ undergoing total knee arthroplasty under spinal anesthesia would be enrolled and randomly divided into two groups (R, "3-in-1" using a 30 ml of ropivacaine 0.375% and a continuous 3-in-1 with a ropivacaine 0.2%(8mL/h) for 48 h after operation, RF: Fifty ug of fentanyl will be added to a bolus(30ml ropivacaine 0.375%) and 1ug/ml of fentanyl will be mixed to a continuous infusion(8mg/h, ropivacaine 0.2%). Spinal anesthesia will be done after the insertion of femoral catheter. IV PCA with hydromorphone(0.15mg/ml, 0-1-10), will be used for rescue analgesics. Visual analgesia scale, hydromorphone consumption, side effects until 48h after operation and satisfaction will be compared.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine+fentanyl | Experimental | Drug: Femoral nerve block with ropivacaine+fentanylFemoral nerve block with ropivacaine+fentanyl Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. |
| Ropivacaine | Experimental | Drug: Femoral nerve block with ropivacaineFemoral nerve block with ropivacaine Interventions: Femoral nerve catheter insertion, spinal anesthesia, IV-PCA with hydromorphone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA PS 1 to 3 undergoing total knee arthroplasty under spinal anesthesia
Key exclusion criteria (1 listed)
- Patients were excluded from this study if they had contraindications to a regional anesthetic technique (e. g., local infection, sepsis, coagulation abnormality), allergy to local anesthetic or fentanyl, preexisting neurologic deficit in the lower extremities, and inability to comprehend the pain scales or use IV patient-controlled analgesia (PCA) device.
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 |
|---|---|---|
| Femoral nerve block with ropivacaine+fentanylAlso: RFRopivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone | Drug | Ropivacaine+fentanyl |
| Femoral nerve block with ropivacaineAlso: RRopivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone | Drug | Ropivacaine |
Primary outcome
Pain on the VAS(Visual Analog Scale)
Time frame: During 48 hour after operation
VAS(resting, movement) at operation day, postoperation 1 day, postoperation 2 day.
1 secondary outcome
Number of participant with side effects
Time frame: During 48 hour after operation
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 14 Sep 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.
Mijung Yun, MD, PhD principal investigator
National medical center
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve block with ropivacaine+fentanyl and Femoral nerve block with ropivacaine in people with Pain, run by National Medical Center, Seoul.
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 1 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Pain on the VAS(Visual Analog Scale) (time frame: During 48 hour after operation). 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 14 Sep 2016.