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This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.
A key component of the multimodal approach to pain management is the intra-operative surgical site injection of a local anesthetic or drug cocktail. There are many formulations used for this purpose. A formulation documented in the literature was implemented by this institution which has dropped the average length of stay dramatically. Concern over the limited half-life of the administered anesthetic and the continued need for opioid administration has led to a search for better drug formulations and administration vehicles. Recently, the FDA approval of an extended release bupivacaine called liposomal bupivacaine was thought to extend the effective half-life of the anesthetic agent and thereby prolong post-operative anesthesia. Use of liposomal bupivacaine in total joint surgery was almost universally adopted after its recent approval and has been an integral part of the "same day total joint" movement.
Studies have suggested improvement in pain control and shortened hospitalizations with the use of liposomal bupivacaine. Other studies have raised questions about the effectiveness of this agent. Recently a randomized double blind study was performed with total knees which demonstrated no improvement in pain management with the addition of liposomal bupivacaine to the multimodal pain management protocol. This study has not been performed in the hip arthroplasty population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Active Comparator | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac |
|
| Hip Cohort Ropivacaine | Active Comparator | Ropivacaine Clonidine Epinephrine Ketorolac |
|
| Knee Cohort Liposomal Bupivacaine | Active Comparator | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac |
|
| Knee Cohort Ropivacaine | Active Comparator | Ropivacaine Clonidine Epinephrine Ketorolac |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | Periarticular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated. | Starting post operatively and then every four hours up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Consumption | Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours. | Starting immediately post operatively up to 48 hours |
| Length of Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Bowen, MD | Kootenai Health | Principal Investigator |
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Patients would be excluded if surgery was cancelled or for some clinical reason did not receive the periarticular injection during surgery.
Hip Cohort: Enrollment began January 2016 and ended October 2017. Patients were recruited sequentially from a single orthopedic surgeon's practice.
Knee Cohort: Enrollment began January 2017 and ended August 2018. Patients were recruited sequentially from three orthopedic surgeon practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hip Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| FG001 | Hip Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| FG002 | Knee Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| FG003 | Knee Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hip Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| 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 | Pain Score | Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated. | Posted | Mean | Standard Deviation | score on a scale | Starting post operatively and then every four hours up to 48 hours |
|
Period of Hospitalization, began at end of surgery and ended at hospital discharge
Because both arms are standard of care, adverse events would only be collected that did not relate to known and expected complications of surgery and total joint replacement.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hip Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
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Anesthesia (general or spinal) followed patient preference and not dictated by protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research Programs | Kootenai Health | 2086254223 | salbritton@kh.org |
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| 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 | Jun 9, 2016 | Jul 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D002045 | Bupivacaine |
| D003000 | Clonidine |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | Periarticular injection |
|
|
| Bupivacaine | Drug | Included as an element of the Liposomal bupivacaine intervention periarticular injection |
|
|
| Clonidine | Drug | Included as an element of both interventions as a standard of care periarticular injection |
|
|
| Ketorolac | Drug | Included as an element of both interventions as a standard of care periarticular injection |
|
|
| Epinephrine | Drug | Included as an element of both interventions as a standard of care periarticular injection |
|
|
Measured in hours
| Start of surgery to hospital discharge up to 140 hours |
| BG001 | Hip Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| BG002 | Knee Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| BG003 | Knee Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Hip Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| OG002 | Knee Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
| OG003 | Knee Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection |
|
|
| Secondary | Narcotic Consumption | Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours. | Posted | Mean | Standard Deviation | morphine equivalents | Starting immediately post operatively up to 48 hours |
|
|
|
| Secondary | Length of Stay | Measured in hours | Posted | Mean | Standard Deviation | Hours | Start of surgery to hospital discharge up to 140 hours |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Hip Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection | 0 | 58 | 0 | 58 | 0 | 58 |
| EG002 | Knee Cohort Liposomal Bupivacaine | Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac Liposomal Bupivacaine: Periarticular injection Bupivacaine: Included as an element of the Liposomal bupivacaine intervention periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection | 0 | 59 | 0 | 59 | 0 | 59 |
| EG003 | Knee Cohort Ropivacaine | Ropivacaine Clonidine Epinephrine Ketorolac Ropivacaine: Periarticular injection Clonidine: Included as an element of both interventions as a standard of care periarticular injection Ketorolac: Included as an element of both interventions as a standard of care periarticular injection Epinephrine: Included as an element of both interventions as a standard of care periarticular injection | 0 | 59 | 0 | 59 | 0 | 59 |
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| D000588 |
| Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Male |
|