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Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395990
Recruitment Status : Completed
First Posted : January 10, 2018
Results First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE January 10, 2018
Results First Submitted Date  ICMJE June 2, 2020
Results First Posted Date  ICMJE June 17, 2020
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE March 27, 2016
Actual Primary Completion Date October 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. [ Time Frame: Baseline, up to 30 minutes. ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Change in pain intensity as measured by 11-point verbal Numeric Rating Scale (NRS-11) for pain. [ Time Frame: Baseline, up to 30 minutes. ]
Relative difference in pain intensity pre- and post-block. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable). Each measured value will be treated independently and not summated.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
Official Title  ICMJE Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, blinded observational study
Masking: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • Procedure: Active comparator: chloroprocaine
    15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
    Other Name: femoral nerve block with chloroprocaine
  • Procedure: Sham comparator: saline
    15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
    Other Name: femoral nerve block with normal saline
Study Arms  ICMJE
  • Active Comparator: chloroprocaine
    15 ml of 2% chloroprocaine via a femoral nerve block technique
    Intervention: Procedure: Active comparator: chloroprocaine
  • Sham Comparator: saline
    15 ml of 0.9% saline via a femoral nerve block technique
    Intervention: Procedure: Sham comparator: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2018)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 19, 2016
Actual Primary Completion Date October 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 56 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03395990
Other Study ID Numbers  ICMJE PRO00067430
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeff Gadsden, MD Duke University
PRS Account Duke University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP