Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adductor Canal Nerve Block Following 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: NCT01939379
Recruitment Status : Terminated
First Posted : September 11, 2013
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

Tracking Information
First Submitted Date  ICMJE September 3, 2013
First Posted Date  ICMJE September 11, 2013
Last Update Posted Date March 13, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Total Opiate pain medication [ Time Frame: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery. ]
At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01939379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2013)
Patient satisfaction with pain control [ Time Frame: We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery ]
Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adductor Canal Nerve Block Following Total Knee Arthroplasty
Official Title  ICMJE Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
Brief Summary The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Post-op Pain
Intervention  ICMJE
  • Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.
  • Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
Study Arms  ICMJE
  • Active Comparator: 15ml ropivacaine
    Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours
    Intervention: Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.
  • Active Comparator: 30ml ropivacaine
    If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.
    Intervention: Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 5, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2013)
66
Actual Study Completion Date  ICMJE July 25, 2017
Actual Primary Completion Date July 25, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is the subject undergoing primary unilateral total knee arthroplasty?
  2. Is the subject 18 to 99 years of age?
  3. Is the subject ASA class 1, 2, or 3?
  4. Does the subject have a BMI less than 35?
  5. Can the subject consent in the English language?

Exclusion Criteria:

  1. Does subject have an allergy to drugs used in this study;
  2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
  3. Does subject have a history of alcohol or drug abuse
  4. Has subject had a previous total knee arthroplasty?
  5. Has subject had any neurologic deficits in the lower extremity being studied?
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 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 NCT01939379
Other Study ID Numbers  ICMJE 5130183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Davinder Ramsingh, MD, Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Loma Linda University
Verification Date March 2019

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