Knee OsteoarthritisNCT02106481
Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery
A study testing Femoral Nerve Catheters and Single Shot Femoral Nerve Blocks in people with Knee Osteoarthritis, run by Eastern Maine Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods of pain control used during total knee joint replacement surgery. The pain medication that will be used for this study is not experimental. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Femoral Nerve Catheters and Single Shot Femoral Nerve Blocks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- 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
- Adults (18-80 years old)
- Scheduled to undergo primary unilateral TKA with Parapatellar approach
- Patient agrees to participate in the study
- Effective femoral nerve block
- No contraindication for spinal or regional anesthesia
Who cannot join
- History of opioid dependence or current chronic analgesic therapy (daily use >4 weeks
- Allergy to study medications
- Known hepatic or renal insufficiency/disease
- Peripheral neuropathy
- Morbid obesity (BMI >40 kg/m2)
- Unable to comply with study protocol
- Pregnancy
- Incarceration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Single Shot Femoral Nerve Block to Femoral Nerve Block Shot Plus Continuous Femoral Nerve Catheter for Total Knee Replacement Surgery; a Randomized, Blinded Controlled Trial.
The purpose of this study is to compare two methods of pain control used during total knee joint replacement surgery. The pain medication that will be used for this study is not experimental.
The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives patients better pain control, increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication. With either the single shot or the catheter the local numbing medication called ropivacaine will be used.
Read the detailed description
The study will be a randomized controlled blinded study with a sham control arm. The patients will be randomized to either a single shot FNB with placement of a catheter on the skin (sham control) or a conventional CFNC with catheter.
The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve. A catheter would be placed on the skin, without penetration, with occlusive dressing applied over the site. A standard size saline bag will be placed on the pump but will not be turned on. The tubing will be opaque and a bag will be placed over the pump to blind the patient to the medication, or lack of medication, being administered. The patient, nursing staff and physical therapists will be blinded to the presence of a sham catheter. The infusion will be labelled 'Study Drug R' or 'Study Drug N' in the electronic medicine prescription.
The group randomized with active drug by CFNB would have a continuous femoral catheter placed using nerve stimulator and ultrasound. Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.
After placement of the femoral nerve block patients will be transported to the operating room and spinal anesthesia with bupivacaine and fentanyl will be performed. Intra-operative sedation of propofol infusion will be titrated to the discretion of the anaesthesia team. Patients will receive scheduled as well as rescue analgesia as per clinical pathway protocol.
Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist) in the post anaesthesia care unit (PACU) after the spinal anaesthesia has worn off. The infusion will be continued for the duration of the catheter, 4am POD one. Patients with SSFNB will not receive any infusion through the sham catheter.
The catheters will be removed on post-operative day (POD) one at about 8 am. Patient's pain score using visual analogue score (VAS) will be assessed. Functional status will be assessed by the physical therapist on POD one. The therapist will assess and document the distance walked, assistive device used, level of assist needed to ambulate, and knee proprioception or continued recommendation of the knee immobilizer.
Patients will be assessed in the PACU and POD 1 and 2. Recordings will be made of total opioid consumption in morphine equivalents, VAS score from 0-10 both at rest and on participation in physical therapy, incidence of nausea and vomiting and functional status during physical therapy.
- Conditions
- Knee Osteoarthritis
- Being tested
- Femoral Nerve Catheters, Single Shot Femoral Nerve Blocks
- Keywords
- TKA, TKR, Knee OA, pain management, Femoral Nerve Catheter, Single Shot Femoral Nerve Blocks
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve CathetersDrug
Also called 0.5% ropivacaine bolus followed by 0.2% infusion
Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.
Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist)
Single Shot Femoral Nerve BlocksDrug
Also called 0.5% ropivacaine
The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Catheters | Active comparator | Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter Receives: Drug: Femoral Nerve Catheters; Drug: Single Shot Femoral Nerve Blocks |
| Single Shot Femoral Nerve Blocks | Active comparator | Patients will receive a Single Shot Femoral Nerve Block and a sham catheter post op. Receives: Drug: Single Shot Femoral Nerve Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.
Measured: 48 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Maine Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Varun Dixit, Eastern Maine Medical Center
- Investigators
- Varun Dixit, MD, Principal investigator, Eastern Maine Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106481
- Sponsor's protocol ID
- 14-1-M-255
- Status last verified
- Aug 2016
- First submitted
- 27 Mar 2014
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Single Shot Femoral Nerve Block to Femoral Nerve Block Shot Plus Continuous Femoral Nerve Catheter for Total Knee Replacement Surgery; a Randomized, Blinded Controlled Trial.
- ClinicalTrials.gov ID
- NCT02106481
- Acronym / sponsor ID
- 14-1-M-255
- Conditions
- Knee Osteoarthritis
- Keywords
- TKA, TKR, Knee OA, pain management, Femoral Nerve Catheter, Single Shot Femoral Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Eastern Maine Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Apr 2014 (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 compare two methods of pain control used during total knee joint replacement surgery. The pain medication that will be used for this study is not experimental.
The investigators will compare the single shot femoral nerve block (SSFNB) and Femoral Nerve Block (FNB) plus continuous femoral nerve catheter (CFNC) to determine which method gives patients better pain control, increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication. With either the single shot or the catheter the local numbing medication called ropivacaine will be used.
Detailed description
The study will be a randomized controlled blinded study with a sham control arm. The patients will be randomized to either a single shot FNB with placement of a catheter on the skin (sham control) or a conventional CFNC with catheter.
The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve. A catheter would be placed on the skin, without penetration, with occlusive dressing applied over the site. A standard size saline bag will be placed on the pump but will not be turned on. The tubing will be opaque and a bag will be placed over the pump to blind the patient to the medication, or lack of medication, being administered. The patient, nursing staff and physical therapists will be blinded to the presence of a sham catheter. The infusion will be labelled 'Study Drug R' or 'Study Drug N' in the electronic medicine prescription.
The group randomized with active drug by CFNB would have a continuous femoral catheter placed using nerve stimulator and ultrasound. Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.
After placement of the femoral nerve block patients will be transported to the operating room and spinal anesthesia with bupivacaine and fentanyl will be performed. Intra-operative sedation of propofol infusion will be titrated to the discretion of the anaesthesia team. Patients will receive scheduled as well as rescue analgesia as per clinical pathway protocol.
Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist) in the post anaesthesia care unit (PACU) after the spinal anaesthesia has worn off. The infusion will be continued for the duration of the catheter, 4am POD one. Patients with SSFNB will not receive any infusion through the sham catheter.
The catheters will be removed on post-operative day (POD) one at about 8 am. Patient's pain score using visual analogue score (VAS) will be assessed. Functional status will be assessed by the physical therapist on POD one. The therapist will assess and document the distance walked, assistive device used, level of assist needed to ambulate, and knee proprioception or continued recommendation of the knee immobilizer.
Patients will be assessed in the PACU and POD 1 and 2. Recordings will be made of total opioid consumption in morphine equivalents, VAS score from 0-10 both at rest and on participation in physical therapy, incidence of nausea and vomiting and functional status during physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Catheters | Active comparator | Drug: Femoral Nerve Catheters, Drug: Single Shot Femoral Nerve BlocksPatients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter |
| Single Shot Femoral Nerve Blocks | Active comparator | Drug: Single Shot Femoral Nerve BlocksPatients will receive a Single Shot Femoral Nerve Block and a sham catheter post op. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (18-80 years old)
- Scheduled to undergo primary unilateral TKA with Parapatellar approach
- Patient agrees to participate in the study
- Effective femoral nerve block
- No contraindication for spinal or regional anesthesia
Key exclusion criteria (8 listed)
- History of opioid dependence or current chronic analgesic therapy (daily use >4 weeks
- Allergy to study medications
- Known hepatic or renal insufficiency/disease
- Peripheral neuropathy
- Morbid obesity (BMI >40 kg/m2)
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 CathetersAlso: 0.5% ropivacaine bolus followed by 0.2% infusionCatheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter. Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist) | Drug | Femoral Nerve Catheters |
| Single Shot Femoral Nerve BlocksAlso: 0.5% ropivacaineThe group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve. | Drug | Femoral Nerve Catheters, Single Shot Femoral Nerve Blocks |
Primary outcome
Pain
Time frame: 48 hours post operatively
Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.
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 3 Aug 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.
Varun Dixit, MD principal investigator
Eastern Maine Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Catheters and Single Shot Femoral Nerve Blocks in people with Knee Osteoarthritis, run by Eastern Maine Medical Center at 1 site in United States.
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 5 inclusion and 8 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 3 Aug 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 United States. 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?
Pain (time frame: 48 hours post operatively). 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 3 Aug 2016.