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Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02773537
Recruitment Status : Completed
First Posted : May 16, 2016
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Drug: Femoral nerve catheter and sciatic nerve block Drug: Adductor canal catheter and selective tibial block Drug: Adductor canal catheter only Not Applicable

Detailed Description:

Pain management for total knee replacement (TKR) patients has evolved rapidly over the previous decade. The most recent advances in anesthesia include peripheral nerve blockade, which offers the promise of earlier postoperative mobilization in addition to effective pain relief. The rapidity with which these advancements have been adopted seems to have outpaced the science to support them. The result has been the institution of countless combinations of perioperative pain management strategies in centers nationwide with little standardization, consistency, or objective evidence. The extent to which these various strategies achieve safe and effective perioperative pain control or functional preservation remains poorly defined. This prospective randomized control trial will aim to identify meaningful patient-centric outcome measures, differentiate from among three perioperative TKR anesthetic and analgesic strategies, and provide a template for interdisciplinary collaboration among orthopedic surgeons, anesthesiologists, physical therapists, and patients. With the knowledge gained further study will continue to refine the most optimal early pain control protocol.

All primary TKR patients undergoing surgery at the Medical University of South Carolina who are able to receive spinal anesthesia will be randomized prior to surgery to one of three forms of lower limb nerve blockade: 1) Continuous femoral nerve catheter plus single injection sciatic nerve block, 2) Adductor canal catheter plus selective tibial nerve block, 3) Adductor canal catheter alone. All patients will receive additional standardized pain medications as well as early mobilization with physical therapy. The primary outcome measure will be postoperative visual analog pain scale (VAS), with secondary measures to include validated patient-reported outcome measures, objective functional measures (timed-up-and-go (TUG), patient satisfaction scores, length of stay, discharge disposition, and complications. The investigators plan to enroll approximately 90 patients. This will allow us to reach our randomization goal of at least 75 patients while taking into account withdrawals. The 75 patients will be randomized into the three treatment three treatment arms over a 6-month recruitment period, with a 3 month follow-up for patient reported outcome and satisfaction data. A focus group will facilitate patient engagement and provide information for generation of a preference survey to guide future study design.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty
Actual Study Start Date : October 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Randomization Group 1
Femoral nerve catheter and sciatic nerve block
Drug: Femoral nerve catheter and sciatic nerve block
This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.

Active Comparator: Randomization Group 2
Adductor canal catheter and selective tibial block
Drug: Adductor canal catheter and selective tibial block
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.

Active Comparator: Randomization Group 3
Adductor canal catheter only
Drug: Adductor canal catheter only
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb




Primary Outcome Measures :
  1. Pain Measurement Via VAS (Visual Analog Scale) [ Time Frame: 48 hours after procedure ]
    The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.


Secondary Outcome Measures :
  1. Narcotic Requirements [ Time Frame: 48 hours after procedure ]
    Narcotic dosages will be measured and reported as oral morphine milligram equivalents.

  2. Functional Outcome Measures- Exstension/Knee Buckling [ Time Frame: 1-2 days after procedure ]
    Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.

  3. Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care) [ Time Frame: Morning of post-op day 1 - 2 days after procedure ]
    Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.

  4. Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked [ Time Frame: Morning of post-op day 1 - 2 days after procedure ]
    Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.

  5. Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds [ Time Frame: Morning of post-op day 1 - 2 days after procedure ]
    Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).

  6. Patient Reported Pain and Function Outcomes [ Time Frame: 6 Weeks after procedure ]

    Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

    Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100.

    Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).


  7. Patient Reported Pain and Function Outcomes [ Time Frame: 3 Months after Procedure ]

    Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.

    Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100.

    Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).




Information from the National Library of Medicine

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

Inclusion Criteria:

  • Males and Females 18 years of age or older
  • Undergoing elective primary total knee arthroplasty
  • Patient is willing and able to give consent and participate

Exclusion Criteria:

  • Inability to receive spinal anesthesia or peripheral nerve block
  • Non-ambulatory patients
  • Non- English speaking patients
  • Vulnerable populations including prisoners

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): NCT02773537


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Jacob Drew, MD Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Study Protocol  [PDF] July 13, 2016

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02773537    
Other Study ID Numbers: Pro00042461
First Posted: May 16, 2016    Key Record Dates
Results First Posted: March 27, 2019
Last Update Posted: March 27, 2019
Last Verified: March 2019