Back to resultsAnalgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Primary Purpose
Osteo Arthritis Knee
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active comparator: chloroprocaine
Sham comparator: saline
Sponsored by
About this trial
This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring femoral nerve block, adductor canal block, analgesia
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for elective total knee arthroplasty
- ASA Physical Status I-III
- BMI 18-40 kg/m2
Exclusion Criteria:
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to any local anesthetic
- Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
- Contraindication to adductor canal or femoral nerve block
Sites / Locations
- Duke University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
chloroprocaine
saline
Arm Description
15 ml of 2% chloroprocaine via a femoral nerve block technique
15 ml of 0.9% saline via a femoral nerve block technique
Outcomes
Primary Outcome Measures
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03395990
Brief Title
Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Official Title
Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2016 (Actual)
Primary Completion Date
October 19, 2016 (Actual)
Study Completion Date
October 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.
Detailed Description
Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
femoral nerve block, adductor canal block, analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, blinded observational study
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Group allocation by sealed envelope; unblinded investigator prepared syringes of study drug (chloroprocaine vs. saline), which look identical to blinded investigator and assessor.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chloroprocaine
Arm Type
Active Comparator
Arm Description
15 ml of 2% chloroprocaine via a femoral nerve block technique
Arm Title
saline
Arm Type
Sham Comparator
Arm Description
15 ml of 0.9% saline via a femoral nerve block technique
Intervention Type
Procedure
Intervention Name(s)
Active comparator: chloroprocaine
Other Intervention Name(s)
femoral nerve block with chloroprocaine
Intervention Description
15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
Intervention Type
Procedure
Intervention Name(s)
Sham comparator: saline
Other Intervention Name(s)
femoral nerve block with normal saline
Intervention Description
15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
Primary Outcome Measure Information:
Title
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Description
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Time Frame
Baseline, up to 30 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for elective total knee arthroplasty
ASA Physical Status I-III
BMI 18-40 kg/m2
Exclusion Criteria:
Inability to cooperate with protocol
Inability to understand or speak English
Allergy to any local anesthetic
Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
Contraindication to adductor canal or femoral nerve block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Gadsden, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
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