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Ultrasound-guided Adductor Canal Block for Total Knee Replacement

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: NCT02100579
Recruitment Status : Completed
First Posted : April 1, 2014
Results First Posted : November 2, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

Brief Summary:
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Condition or disease Intervention/treatment Phase
Complications; Arthroplasty Knee Injuries Drug: Bupivacaine Drug: Preservative free normal saline Phase 4

Detailed Description:
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.
Study Start Date : March 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Group
Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine
Drug: Bupivacaine
10 ml of 0.25% bupivacaine
Other Name: Sensorcaine

Placebo Comparator: Control Group
Ultrasound-guided sham block with 10 ml of preservative free normal saline
Drug: Preservative free normal saline
10 ml of preservative free normal saline
Other Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. Opioid Consumption (mg morEq) [ Time Frame: 36 hours ]
    Opioid consumption (morphine equivalents)


Secondary Outcome Measures :
  1. Visual Analog Scale Pain Score [ Time Frame: Pain burden at 36hr ]
    Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.

  2. Length of Hospitalization [ Time Frame: 0 to 192 hours ]
    The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

  • Patient refusal
  • American Society of Anesthesiologists physical status classification of 4 or higher
  • Pre-existing neuropathy in the femoral or sciatic distribution
  • Coagulopathy
  • Infection at the site
  • Chronic opioid use (greater than 3 months)
  • Pregnancy
  • Medical conditions limiting physical therapy participation
  • Any other contra-indication to regional anesthesia

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): NCT02100579


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Antoun Nader, MD Northwestern University Feinberg School of Medicine

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Responsible Party: Antoun Nader, Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02100579    
Other Study ID Numbers: STU00088239
STU00088239 ( Other Identifier: Northwestern University IRB )
First Posted: April 1, 2014    Key Record Dates
Results First Posted: November 2, 2016
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents