Trial Outcomes & Findings for Evaluation Exparel Delivered in Knee Replacement (NCT NCT02011464)

NCT ID: NCT02011464

Last Updated: 2017-08-08

Results Overview

Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 72 hours post-operative
• Results posted on: 2017-08-08

Participant Flow

Participant milestones

Measure	Exparel Inflitration Exparel infiltrated into the posterior compartment of the knee	Control Saline infiltrated into posterior compartment of the knee
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation Exparel Delivered in Knee Replacement

Baseline characteristics by cohort

Measure	Exparel Inflitration n=10 Participants Exparel infiltrated into the posterior compartment of the knee	Control n=10 Participants Saline infiltrated into posterior compartment	Total n=20 Participants Total of all reporting groups
Age, Continuous	66.1 years STANDARD_DEVIATION 4.7 • n=5 Participants	62.8 years STANDARD_DEVIATION 6.0 • n=7 Participants	64.1 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours post-operative

Subject reported post-surgical pain using the visual analog scale (VAS) during the hospital stay and after discharge. This is a 0-10 point numeric rating scale where 0 is no pain and 10 is the highest level of pain.

Outcome measures

Measure	Exparel Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 8 Hours n=10 Participants Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 8 Hours n=10 Participants Pain scores using the Number Rating Scale (NRS) from 0 - 10	Exparel Group/Average Pain Scores at 12 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 12 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 24 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 24 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 48 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 48 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 72 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 72 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10
Subjective Pain	3.80 units on a scale Standard Deviation 3.26	4.00 units on a scale Standard Deviation 2.75	3.44 units on a scale Standard Deviation 3.61	5.30 units on a scale Standard Deviation 3.02	3.50 units on a scale Standard Deviation 3.25	3.90 units on a scale Standard Deviation 2.47	3.80 units on a scale Standard Deviation 3.52	4.20 units on a scale Standard Deviation 2.82	2.60 units on a scale Standard Deviation 2.46	3.50 units on a scale Standard Deviation 2.95	3.00 units on a scale Standard Deviation 3.16	3.70 units on a scale Standard Deviation 3.50

SECONDARY outcome

Timeframe: 72 hours post-operative

Average postoperative narcotics administered in total milligrams of morphine equivalents

Outcome measures

Measure	Exparel Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 8 Hours Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 8 Hours Pain scores using the Number Rating Scale (NRS) from 0 - 10	Exparel Group/Average Pain Scores at 12 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 12 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 24 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 24 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 48 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 48 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 72 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 72 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10
Post-operative Narcotic Use	4.31 mgs Standard Deviation 2.40	5.75 mgs Standard Deviation 3.63	—	—	—	—	—	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hours post-operative

Population: Number of patients with opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain

Secondary end points will include the incidence of opioid related side effects (nausea, vomiting, pruritis, constipation, respiratory depression, and hypoxia) and hemodynamic perturbations related to pain

Outcome measures

Measure	Exparel Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 4 Hours n=10 Participants Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 8 Hours Pain scores using the Number Rating Scale (NRS) from 0 - 10	Control Group/Average Pain Scores at 8 Hours Pain scores using the Number Rating Scale (NRS) from 0 - 10	Exparel Group/Average Pain Scores at 12 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 12 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 24 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 24 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 48 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 48 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Exparel Group/Average Pain Scores at 72 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10	Control Group/Average Pain Scores at 72 Hours Pain scores using the Numeric Rating Scale (NRS) 0 - 10
Side Effects of Analgesia	3 participants	2 participants	—	—	—	—	—	—	—	—	—	—

Adverse Events

Exparel Inflitration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Dr. Piyush M Gupta

Maimonides Medical Center

Phone: 7182837189

Email: pgupta@maimonidesmed.org

Results disclosure agreements

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