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Adductor Canal Nerve Block Following Total Knee Arthroplasty

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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

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.

Condition or disease Intervention/treatment Phase
Post-op Pain 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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
Study Start Date : September 2013
Actual Primary Completion Date : July 25, 2017
Actual Study Completion Date : July 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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
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.
Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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?

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): NCT01939379


Locations
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United States, California
Loma Linda University Medical Center East Campus Hospital
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University

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Responsible Party: Davinder Ramsingh, MD, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT01939379     History of Changes
Other Study ID Numbers: 5130183
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Davinder Ramsingh, MD, Loma Linda University:
Total knee arthroplasty
nerve block
Pain control after surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Acetaminophen, hydrocodone drug combination
Morphine
Oxycodone
Ropivacaine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antipyretics