4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans



Status:Active, not recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 85
Updated:12/5/2018
Start Date:October 2016
End Date:April 2020

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After total joint replacement, early hospital discharge to home (with patients capable of
continuing a home-based rehabilitation program) is a cost- effective management strategy.
This project will use improved local anesthetic nerve block techniques to enhance technical
capability and clinical practice by (i) reducing pain and other morbidities during recovery,
(ii) improving weight-bearing achievement during in-hospital physical therapy to allow for
earlier return home, and (iii) continued rehabilitation as an outpatient at home when
feasible (versus in an extended care facility).

Patients will have spinal anesthesia for their hip or knee replacement surgery. They will
also receive the nerve blocks described above

Inclusion Criteria:

1. Age between 18 and 85, and undergoing a total knee or hip replacement.

2. Fluent in English, decision competent, willing and able to provide written informed
consent, and able to complete the study's schedule of assessments.

3. Able to walk >3m without an assisting device.

4. Have a BMI ≤ 40 kg/m2.

Exclusion Criteria:

1. Current participation in another orthopedic/Physical Therapy/rehab/anesthesiology
interventional clinical trial.

2. Are at significant behavioral risks or have refractory major psychiatric disorders.

3. Revision surgery on the same extremity.

4. Have an American Surgical Association (ASA) Physical Status classification of 4 or
higher.

5. Have been diagnosed with clinically significant neuropathy with its origins in either
diabetes or other causes; have neuromuscular disease that would influence data
collection.

6. Have a surgically-fused lumbar spine, or a spinal cord simulator, or other condition
that would contraindicate or prohibit the conduct of spinal anesthesia.

7. At significant risk for postoperative substance abuse, or immediate-postoperative
substance abuse withdrawal symptoms (alcohol, cocaine, enrolled in methadone or
buprenorphine opioid withdrawal programs, etc.) Previous or current use of marijuana
will not be an exclusion for study enrollment.

8. Are undergoing Total Knee Arthroplasty (TKA)/Total Hip Arthroplasty (THA) for a tumor.

9. Have contraindications (e.g., anaphylaxis) to any of the study drugs.

10. Have a systemic fungal infection.

11. Have a known hypersensitivity to bupivacaine hydrochloride or to any local anesthetic
of the amide-type or to other components of bupivacaine hydrochloride solutions.

12. Have a known or suspected buprenorphine hypersensitivity (not including nausea and/or
vomiting).

13. Have a gastro-intestinal (GI) obstruction.

14. Have paralytic ileus.

15. Pregnant women

16. Have had a kidney or liver transplant.

Veterans will not be excluded from participation based on smoking status, diagnosis of
obstructive sleep apnea, or baseline monitored consumption of therapeutic opioids for
documented medical indications; instead, these variables will be codified and quantified
for subsequent covariate statistical analysis.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15240
Principal Investigator: Brian Williams, MD, MBA
Phone: 412-360-6666
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mi
from
Pittsburgh, PA
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