Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT02773537
Study type Interventional
Source Medical University of South Carolina
Contact
Status Completed
Phase N/A
Start date October 2015
Completion date November 2016

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Recruiting NCT05002387 - Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis N/A
Recruiting NCT06080763 - Biomechanics and Clinical Outcomes in Responders and Non-Responders
Completed NCT03008967 - A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark N/A
Withdrawn NCT02255877 - ZIPS Study - Zip Incision Approximation vs. STAPLE Phase 4
Completed NCT02642731 - Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty N/A
Completed NCT02525588 - Polyethylene Wear Study on the Triathlon Total Knee Prosthesis N/A
Completed NCT01799772 - The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA Phase 1/Phase 2
Completed NCT02520531 - Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty N/A
Completed NCT03183856 - Comparison of Ambulatory and Functional Improvement by Morning Walk N/A
Completed NCT03569397 - Music Therapy Versus Control for Total Knee Arthroplasty N/A
Terminated NCT02711592 - Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study N/A
Completed NCT03145493 - Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid N/A
Terminated NCT05602701 - Preoperative Prediction of Postoperative Physical Function
Recruiting NCT03570944 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
Withdrawn NCT02553122 - The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty Phase 3
Recruiting NCT02385383 - An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study N/A
Completed NCT02121392 - Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty N/A
Terminated NCT02155712 - Triathlon Tritanium Knee Outcomes Study N/A
Completed NCT02682498 - Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj Phase 4