Total Hip and Knee Arthroplasty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGLiposomal Bupivacaine
Periarticular injection
DRUGRopivacaine
Periarticular injection
DRUGBupivacaine
Included as an element of the Liposomal bupivacaine intervention periarticular injection
DRUGClonidine
Included as an element of both interventions as a standard of care periarticular injection
DRUGKetorolac
Included as an element of both interventions as a standard of care periarticular injection
DRUGEpinephrine
Included as an element of both interventions as a standard of care periarticular injection
Sponsors
Kootenai Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)
Exclusion criteria
* Current use of opioid drugs * Revision surgery * Surgical complication (femoral fracture with implant insertion) * Inability to provide Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | Starting post operatively and then every four hours up to 48 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Consumption | Starting immediately post operatively up to 48 hours | Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours. |
| Length of Stay | Start of surgery to hospital discharge up to 140 hours | Measured in hours |
Participant flow
Recruitment details
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.
Pre-assignment details
Patients would be excluded if surgery was cancelled or for some clinical reason did not receive the periarticular injection during surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 58 |
| 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 | 59 |
| 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 | 59 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Hip Cohort Liposomal Bupivacaine | Hip Cohort Ropivacaine | Knee Cohort Liposomal Bupivacaine | Knee Cohort Ropivacaine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 9 | 66 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 60 Participants | 58 Participants | 59 Participants | 59 Participants | 236 Participants |
| Sex: Female, Male Female | 41 Participants | 38 Participants | 39 Participants | 29 Participants | 147 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 20 Participants | 30 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 60 | 0 / 58 | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 | 0 / 59 | 0 / 59 |
Outcome results
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.
Time frame: Starting post operatively and then every four hours up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Pain Score | 3.78 score on a scale | Standard Deviation 2.22 |
| Hip Cohort Ropivacaine | Pain Score | 3.85 score on a scale | Standard Deviation 2.01 |
| Knee Cohort Liposomal Bupivacaine | Pain Score | 3.3 score on a scale | Standard Deviation 2 |
| Knee Cohort Ropivacaine | Pain Score | 3.4 score on a scale | Standard Deviation 2.3 |
Secondary
Length of Stay
Measured in hours
Time frame: Start of surgery to hospital discharge up to 140 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Length of Stay | 33.8 Hours | Standard Deviation 48.24655 |
| Hip Cohort Ropivacaine | Length of Stay | 50.3 Hours | Standard Deviation 48.41333 |
| Knee Cohort Liposomal Bupivacaine | Length of Stay | 36.0 Hours | Standard Deviation 29.88427 |
| Knee Cohort Ropivacaine | Length of Stay | 38.4 Hours | Standard Deviation 18.83953 |
Secondary
Narcotic Consumption
Total amount of narcotics administered as calculated in oral morphine equivalent dose immediate post operatively up to 48 hours.
Time frame: Starting immediately post operatively up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hip Cohort Liposomal Bupivacaine | Narcotic Consumption | 48.8 morphine equivalents | Standard Deviation 22.9 |
| Hip Cohort Ropivacaine | Narcotic Consumption | 57.4 morphine equivalents | Standard Deviation 21.8 |
| Knee Cohort Liposomal Bupivacaine | Narcotic Consumption | 52.2 morphine equivalents | Standard Deviation 28.4 |
| Knee Cohort Ropivacaine | Narcotic Consumption | 50.0 morphine equivalents | Standard Deviation 22 |