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=99 Participants
|
62.8 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
64.1 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 hours post-operativeSubject 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-operativeAverage 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
|
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OTHER_PRE_SPECIFIED outcome
Timeframe: 72 hours post-operativePopulation: 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
|
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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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place