Trial Outcomes & Findings for A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty (NCT NCT02543801)

NCT ID: NCT02543801

Last Updated: 2019-10-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 239 participants
• Primary outcome timeframe: Starting post operatively and then every four hours up to 48 hours
• Results posted on: 2019-10-18

Participant Flow

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.

Patients would be excluded if surgery was cancelled or for some clinical reason did not receive the periarticular injection during surgery.

Participant milestones

Measure	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	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	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	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
Overall Study STARTED	61	60	59	59
Overall Study COMPLETED	60	58	59	59
Overall Study NOT COMPLETED	1	2	0	0

Reasons for withdrawal

Measure	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	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	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	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
Overall Study Protocol Violation	1	2	0	0

Baseline Characteristics

At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.

Baseline characteristics by cohort

Measure	Hip Cohort Liposomal Bupivacaine n=60 Participants 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	Hip Cohort Ropivacaine n=58 Participants 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	Knee Cohort Liposomal Bupivacaine n=59 Participants 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	Knee Cohort Ropivacaine n=59 Participants 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	Total n=236 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 10 • n=60 Participants	64 years STANDARD_DEVIATION 11 • n=58 Participants	66 years STANDARD_DEVIATION 10 • n=59 Participants	67 years STANDARD_DEVIATION 9 • n=59 Participants	66 years STANDARD_DEVIATION 10 • n=236 Participants
Sex: Female, Male Female	41 Participants n=60 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	38 Participants n=58 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	39 Participants n=59 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	29 Participants n=59 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	147 Participants n=236 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.
Sex: Female, Male Male	19 Participants n=60 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	20 Participants n=58 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	20 Participants n=59 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	30 Participants n=59 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.	89 Participants n=236 Participants • At the end of the study enrollment period 2 patients cancelled their surgeries and these were not replaced.
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	60 Participants n=60 Participants	58 Participants n=58 Participants	59 Participants n=59 Participants	59 Participants n=59 Participants	236 Participants n=236 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Hip Cohort Liposomal Bupivacaine n=60 Participants 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	Hip Cohort Ropivacaine n=58 Participants 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	Knee Cohort Liposomal Bupivacaine n=59 Participants 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	Knee Cohort Ropivacaine n=59 Participants 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
Pain Score	3.78 score on a scale Standard Deviation 2.22	3.85 score on a scale Standard Deviation 2.01	3.3 score on a scale Standard Deviation 2.0	3.4 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Hip Cohort Liposomal Bupivacaine n=60 Participants 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	Hip Cohort Ropivacaine n=58 Participants 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	Knee Cohort Liposomal Bupivacaine n=59 Participants 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	Knee Cohort Ropivacaine n=59 Participants 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
Narcotic Consumption	48.8 morphine equivalents Standard Deviation 22.9	57.4 morphine equivalents Standard Deviation 21.8	52.2 morphine equivalents Standard Deviation 28.4	50.0 morphine equivalents Standard Deviation 22.0

SECONDARY outcome

Timeframe: Start of surgery to hospital discharge up to 140 hours

Measured in hours

Outcome measures

Measure	Hip Cohort Liposomal Bupivacaine n=60 Participants 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	Hip Cohort Ropivacaine n=58 Participants 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	Knee Cohort Liposomal Bupivacaine n=59 Participants 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	Knee Cohort Ropivacaine n=59 Participants 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
Length of Stay	33.8 Hours Standard Deviation 48.24655	50.3 Hours Standard Deviation 48.41333	36.0 Hours Standard Deviation 29.88427	38.4 Hours Standard Deviation 18.83953

Adverse Events

Hip Cohort Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hip Cohort Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Knee Cohort Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Knee Cohort Ropivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research Programs

Kootenai Health

Phone: 2086254223

Email: salbritton@kh.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place