Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 13232002 | Other Identifier | USARMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) | Experimental | Patients will receive a nerve block consisting of bupivacaine plus clonidine-buprenorphine-dexamethasone (Bupivacaine-CBD) |
|
| Bupivacaine Only (control arm) | Active Comparator | Patients will receive a nerve block consisting of bupivacaine only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone) | Drug | Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Quality of Recovery 15 Item Scale (QoR-15) Total Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Williams, MD, MBA | VA Pittsburgh Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37256753 | Derived | Aloziem OU, Williams BA, Mikolic JM, Boudreaux-Kelly MY, Faruque S, Piva SR, Ibinson JW, Switzer GE. Assessing Common Content and Responsiveness of the QoR-15 and the SF-8 in the Context of Recovery from Regional Anesthesia for Joint Replacement. Mil Med. 2023 Nov 3;188(11-12):e3469-e3476. doi: 10.1093/milmed/usad191. | |
| 34730810 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study temporarily on-hold (6), Failed screening (3), Failed spinal (2), No study staff available (2), Surgery deferred (2), Current participation in another clinical trial (1), Intra-operative peri-prosthetic fracture (1), Patient chose another hospital (1), Surgery cancelled due to profuse vomiting after spinal anesthesia (1), and Uni-compartmental knee arthroplasty instead of total knee (1).
Participants were enrolled from November 2016 to October 2018 after HIPAA-compliant contact of the study recruiter by either the preoperative clinic or the orthopedic clinic clinical staff. Of the 571 screened, 473 were not eligible due to failing study inclusion/exclusion criteria (N=151), programmatic reasons (N=145), or not willing to participate (N=177), resulting in 98 patients enrolled in the study. Twenty of these were early terminations, leaving 78.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD) Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements |
| FG001 | Bupivacaine Only (Control Arm) | Patients will receive a nerve block consisting of bupivacaine only. Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and hip replacements |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Veterans undergoing hip/knee replacement surgery completing the study course
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | Patients will receive a nerve blocks consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD) Bupivacaine + BCD (buprenorphine, clonidine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who completed the protocol. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Operative day after surgery (7AM-9AM EST) |
|
Throughout hospitalization, and at 2-week and 6-week postoperative visits.
Adverse events reported here only include those that were unexpected in the normal course of surgery/anesthesia.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | Patients will receive a nerve block consisting of bupivacaine plus buprenorphine-clonidine-dexamethasone (Bupivacaine-BCD) Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot drop | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One possibly block-related adverse event (foot drop after TKA), which resolved spontaneously over 4 months. The sciatic block for this patient was placed with ultrasound guidance; the intraoperative tourniquet time was 125 minutes (300 mmHg). |
The sample size determined before the study began was N=100 patients to undergo primary THA and N=100 patients to undergo primary TKA, with these patients not undergoing physical therapy until day-one after surgery; these sample sizes were ultimately not achieved. By early 2018, same-day physical therapy (after surgery) became the new hospital guideline for patients undergoing primary THA and TKA, such that by mid-2018, the study was interrupted. Only the described 78 patients completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian A. Williams, MD, MBA | VA Pittsburgh Health System, and University of Pittsburgh | 412-360-1602 | brian.williams6@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 12, 2018 | Oct 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 11, 2018 | Oct 13, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003000 | Clonidine |
| D002047 | Buprenorphine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bupivacaine Only (control arm) | Drug | Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements |
|
|
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery.
| 6 weeks post-operation |
| 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 |
| 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 |
| 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 |
| Williams BA, Ibinson JW, Mikolic JM, Boudreaux-Kelly MY, Paiste HJ, Gilbert KL, Bonant SA, Ritter ME, Ezaru CS, Muluk VS, Piva SR. Day-One Pain Reductions After Hip and Knee Replacement When Buprenorphine-Clonidine-Dexamethasone Is Added to Bupivacaine Nerve/Plexus Blocks: A Randomized Clinical Trial. Pain Med. 2022 Jan 3;23(1):57-66. doi: 10.1093/pm/pnab325. |
| Bupivacaine Only (Control Arm) |
Patients will receive a nerve block consisting of bupivacaine only. Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee and Hip replacements. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI (kg/m^2) | Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes | Number | participants |
|
| Bupivacaine Only (Control Arm) |
Patients will receive a nerve block consisting of bupivacaine only. Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements |
|
|
|
| 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. | All participants who completed the protocol. | Posted | Mean | Standard Deviation | units on a scale | 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. | All participants who completed the protocol. | Posted | Mean | Standard Deviation | units on a scale | 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. | All participants who completed the protocol. There was missing data for one participant in the Bupivacaine Only arm. | Posted | Mean | Standard Deviation | score on a scale | 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. | All participants who completed the protocol. There was missing data for one participant in the Bupivacaine + BCD arm. | Posted | Mean | Standard Deviation | score on a scale | 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. | All participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm. | Posted | Mean | Standard Deviation | score on a scale | 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. | All of the participants who completed the protocol. There was missing data for four participants in the Bupivacaine + BCD arm. | Posted | Mean | Standard Deviation | meters per second | 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. | All participants who completed the protocol. There was missing data for five participants in the Bupivacaine + BCD arm. | Posted | Mean | Standard Deviation | seconds | 6 weeks post-operation |
|
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 1 |
| 62 |
| EG001 | Bupivacaine Only (Control Arm) | Patients will receive a nerve block consisting of bupivacaine only. Bupivacaine Only (control arm): Nerve blocks before surgery of L2-L4 and L4-S3 for Knee/Hip replacements | 0 | 16 | 0 | 16 | 0 | 16 |
|
Not provided
Not provided
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |