Clinical trial NCT02773537: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain Measurement Via VAS (Visual Analog Scale)
timeFrame: 48 hours after procedure
Secondary outcomes:
measure: Narcotic Requirements
timeFrame: 48 hours after procedure
measure: Functional Outcome Measures- Exstension/Knee Buckling
timeFrame: 1-2 days after procedure
measure: Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)
timeFrame: Morning of post-op day 1 - 2 days after procedure
measure: Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked
timeFrame: Morning of post-op day 1 - 2 days after procedure
measure: Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds
timeFrame: Morning of post-op day 1 - 2 days after procedure
measure: Patient Reported Pain and Function Outcomes
timeFrame: 6 Weeks after procedure
measure: Patient Reported Pain and Function Outcomes
timeFrame: 3 Months after Procedure
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jacob Drew, MD
role: PRINCIPAL_INVESTIGATOR
References: