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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

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Procedure: Active comparator: chloroprocaine Procedure: Sham comparator: saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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
Official Title: Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
Actual Study Start Date : March 27, 2016
Actual Primary Completion Date : October 19, 2016
Actual Study Completion Date : October 19, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: chloroprocaine
15 ml of 2% chloroprocaine via a femoral nerve block technique
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

Sham Comparator: saline
15 ml of 0.9% saline via a femoral nerve block technique
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




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   56 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395990


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Jeff Gadsden, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03395990    
Other Study ID Numbers: PRO00067430
First Posted: January 10, 2018    Key Record Dates
Results First Posted: June 17, 2020
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Duke University:
femoral nerve block
adductor canal block
analgesia
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents