Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femoral Nerve Catheters
Single Shot Femoral Nerve Blocks
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring TKA, TKR, Knee OA, pain management, Femoral Nerve Catheter, Single Shot Femoral Nerve Blocks
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Eastern Maine Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Femoral Nerve Catheters
Single Shot Femoral Nerve Blocks
Arm Description
Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter
Patients will receive a Single Shot Femoral Nerve Block and a sham catheter post op.
Outcomes
Primary Outcome Measures
Pain
Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.
Secondary Outcome Measures
Full Information
NCT ID
NCT02106481
First Posted
March 27, 2014
Last Updated
August 1, 2016
Sponsor
Eastern Maine Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02106481
Brief Title
Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Maine Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
TKA, TKR, Knee OA, pain management, Femoral Nerve Catheter, Single Shot Femoral Nerve Blocks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Femoral Nerve Catheters
Arm Type
Active Comparator
Arm Description
Patients will receive a Single Shot Femoral Nerve Block along with a conventional continuous femoral nerve catheter
Arm Title
Single Shot Femoral Nerve Blocks
Arm Type
Active Comparator
Arm Description
Patients will receive a Single Shot Femoral Nerve Block and a sham catheter post op.
Intervention Type
Drug
Intervention Name(s)
Femoral Nerve Catheters
Other Intervention Name(s)
0.5% ropivacaine bolus followed by 0.2% infusion
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Single Shot Femoral Nerve Blocks
Other Intervention Name(s)
0.5% ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.
Time Frame
48 hours post operatively
Other Pre-specified Outcome Measures:
Title
Restfulness of sleep
Description
Patients will be asked if they had difficulty sleeping because of pain.
Time Frame
8 AM post op day 1
Title
Nausea and Vomiting
Description
Nausea and Vomiting- Written questionnaire administer to patient. Did the patient experience Nausea? Yes/No. Using scale 0- no nausea, 1- nausea no vomiting, 2-vomiting, 3- persistent vomiting.
Time Frame
8 AM post op day 1
Title
Distance Walked
Description
Distance walked- Distance will be measured in meters and assistive device used (including knee immobilizer)
Time Frame
8 AM post op day 1, 48 hours post op, 3 months post op
Title
Level of Assist for Ambulation
Description
Level of Assist for Ambulation- Independent (no device, timely, safely), modified independent (assistive device, safely or timeliness issues) supervision (requires standby assist, cueing), minimal assist (patient expends 75% of effort needed to completed task) , moderate assist (patient expends 50-74% of effort needed to completed task), max assist (patient expends 25-49% of effort needed to completed task), total assist (patient expends >25% of the effort needed to complete task).
Time Frame
8 AM post op day 1, 48 hours post op, 3 months post op
Title
Hours until knee immobilizer is discharged
Description
Hours until knee immobilizer is discharged - As a gauge of knee proprioception and quad strength the physical therapist will discharge the knee immobilizer when the patient can safely mobilize without the brace. The hours from surgery to discharge will be measured and >24 hours after surgery will be considered delayed discharge where <24 hours post op will be considered satisfactory.
Time Frame
8 AM post op day 1, 48 hours post op, 3 months post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varun Dixit, MD
Organizational Affiliation
Eastern Maine Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
12. IPD Sharing Statement
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Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery
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