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

• 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: Medical University of South Carolina
• Information provided by (Responsible Party): Medical University of South Carolina

Tracking Information

• First Submitted Date: May 3, 2016
• First Posted Date: May 16, 2016
• Results First Submitted Date: August 9, 2018
• Results First Posted Date: March 27, 2019
• Last Update Posted Date: March 27, 2019
• Actual Study Start Date: October 2015
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2019)

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.

Original Primary Outcome Measures (submitted: May 11, 2016)

• Pain Measurement via VAS [ 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.
• Pain Measurement via Medication [ Time Frame: 48 hours after procedure ]
  Pain will be measured indirectly via total in-hospital opioid consumption.

Current Secondary Outcome Measures (submitted: March 6, 2019)

• Narcotic Requirements [ Time Frame: 48 hours after procedure ]
  Narcotic dosages will be measured and reported as oral morphine milligram equivalents.
• 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.
• 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.
• 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.
• 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).
• 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).
• 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).

Original Secondary Outcome Measures (submitted: May 11, 2016)

• Functional Outcome Measures [ 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. Additionally, in the morning of postoperative day #1, a Katz Index of Independence in Activities of Daily Living score will be calculated. On the morning of postoperative day #2, the therapist will document distance walked by the patient, passive range of motion (flexion and extension), a timed up-and-go test (TUG), and calculate the Activity Measure for Post-Acute Care (AM-PAC) score.
• Patient Reported Pain and Function Outcomes [ Time Frame: 6 Weeks after procedure ]
  Patient reported outcome measures, specifically Short Form Health Survey (SF-12), Patient Reported Outcome Measurement Information System (PROMIS), and Knee injury and Osteoarthritis Outcome Score (KOOS) will be collected at 6 weeks and 3 months postoperatively.
• Patient Reported Pain and Function Outcomes [ Time Frame: 3 Months after Procedure ]
  Patient reported outcome measures, specifically Short Form Health Survey (SF-12), Patient Reported Outcome Measurement Information System (PROMIS), and Knee injury and Osteoarthritis Outcome Score (KOOS) will be collected at 3 months postoperatively.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: May 11, 2016)

Patient Engagement via Focus Group [ Time Frame: 3 months after procedure ]

At three months, a random subset of four patients from each randomization arm will be invited to participate in a focus group. The purpose of the focus group will be to facilitate patient engagement with the hope of fulfilling our primary aim of this study, which is to identify the most meaningful outcome measures for perioperative analgesia among the TKA patients themselves. Qualitative data obtained during the recorded session will prompt discussion related to the overall patient experience in addition to individual experiences related specifically to analgesia, postoperative mobility, transitioning to the out-patient setting, and involvement in a randomized trial.

Descriptive Information

• Brief Title: Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial
• Official Title: Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty
• 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).

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Arthroplasty, Replacement, Knee

Intervention

• 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.
• 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.
• 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

Study Arms

• Active Comparator: Randomization Group 1
  Femoral nerve catheter and sciatic nerve block
  Intervention: Drug: Femoral nerve catheter and sciatic nerve block
• Active Comparator: Randomization Group 2
  Adductor canal catheter and selective tibial block
  Intervention: Drug: Adductor canal catheter and selective tibial block
• Active Comparator: Randomization Group 3
  Adductor canal catheter only
  Intervention: Drug: Adductor canal catheter only

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 11, 2016): 75
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 2016
• Actual Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02773537
• Other Study ID Numbers: Pro00042461
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Medical University of South Carolina
• Study Sponsor: Medical University of South Carolina
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jacob Drew, MD; Medical University of South Carolina

• PRS Account: Medical University of South Carolina
• Verification Date: March 2019