Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/29/2019 |
Start Date: | October 2015 |
End Date: | November 2016 |
Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty
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).
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).
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.
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.
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
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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