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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891798
• Other study ID #: PRO 1357
• Secondary ID: 13232002
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: August 20, 2021

Study information

• Verified date: January 2022
• Source: VA Pittsburgh Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: August 20, 2021
• Est. primary completion date: July 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
• Bupivacaine Only (control arm)
Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Brian Williams	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline	SF-MPQ version 2 total score difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.	Baseline, Post-Operative day after surgery (7AM-9AM EST)
Primary	SF-MPQ2 Continuous Pain Subscore Difference From Baseline	Continuous pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.	Baseline, Post-Operative day after surgery (7AM-9AM EST)
Primary	SF-MPQ2 Intermittent Pain Subscore Difference From Baseline	Intermittent pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain.	Baseline, Post-Operative day after surgery (7AM-9AM EST)
Secondary	Quality of Recovery 15 Item Scale (QoR-15) Total Score	Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.	Day after surgery (7AM-9AM EST)
Secondary	Quality of Recovery 15 Item Scale (QoR-15) Total Score	Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.	6 weeks post-operation
Secondary	Performed-based Physical Function is Assessed Using the Standing Balance Test.	The Standing Balance Test score based on the ability of the participant to perform a series of standing exercises. Scores range from 0 to 4, with 4 indicating a longer time holding the stand (a better outcome).; This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test will capture the domains of muscle strength and activation, and balance.	6 weeks post-operation
Secondary	Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test.	The Self-Selected Gait Speed Test is a timed test based on the ability of the participant to walk a 4 meter distance.; This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test captures the ability to walk.	6 weeks post-operation
Secondary	Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test.	The Repeated Chair Stand Test is a timed test based on the ability of the participant to perform a series of standing exercises.; This test is germane to subjects with total joint replacement that are easily performed in the clinical settings. The test will capture the domains of muscle strength and activation, and balance.	6 weeks post-operation