Trial Outcomes & Findings for Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy (NCT NCT01907191)
NCT ID: NCT01907191
Last Updated: 2022-08-16
Results Overview
Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 \& 3.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Post Operative Day 1, 2 & 3
Results posted on
2022-08-16
Participant Flow
Participant milestones
| Measure |
Liposomal Bupivacaine
Ultrasound guided injection of liposomal bupivacaine
liposomal bupivacaine: (Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy
|
Bupivacaine
Bupivacaine (around the anterior, lateral and medial aspect of hip joint)
Bupivacaine: (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
10
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bupivacaine
n=10 Participants
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
Liposomal Bupivacaine
n=13 Participants
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.8 years
STANDARD_DEVIATION 8.9 • n=10 Participants
|
30.5 years
STANDARD_DEVIATION 8.28 • n=13 Participants
|
34.5 years
STANDARD_DEVIATION 10.48 • n=23 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
7 Participants
n=13 Participants
|
11 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=13 Participants
|
12 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Post Operative Day 1, 2 & 3Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 \& 3.
Outcome measures
| Measure |
Bupivacaine
n=10 Participants
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
Liposomal Bupivacaine
n=13 Participants
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
|---|---|---|
|
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Post Operative Day 3
|
2.3 number of 5 mg oxycontin
Standard Deviation 2.00
|
0.9 number of 5 mg oxycontin
Standard Deviation 1.38
|
|
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Post Operative Day 1
|
2.8 number of 5 mg oxycontin
Standard Deviation 1.87
|
1.9 number of 5 mg oxycontin
Standard Deviation 1.50
|
|
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Post Operative Day 2
|
2.7 number of 5 mg oxycontin
Standard Deviation 2.00
|
2.2 number of 5 mg oxycontin
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: Post Operative Day 1, 2 & 3Analysis of pain scores (at rest and ambulation) during hospital stay. Measured on a 10 point pain scale (1 being no pain and 10 being worst pain imaginable)
Outcome measures
| Measure |
Bupivacaine
n=10 Participants
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
Liposomal Bupivacaine
n=13 Participants
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
|---|---|---|
|
Pain Scores
Pain Scores at rest- Post Operative Day 1
|
1.9 score on a scale
Standard Deviation 0.94
|
1.1 score on a scale
Standard Deviation 1.44
|
|
Pain Scores
Pain Scores on Ambulation- Post Operative Day 1
|
3.1 score on a scale
Standard Deviation 2.12
|
3.9 score on a scale
Standard Deviation 2.43
|
|
Pain Scores
Pain Scores at rest- Post Operative Day 2
|
1.9 score on a scale
Standard Deviation 1.47
|
1.0 score on a scale
Standard Deviation 1.35
|
|
Pain Scores
Pain Scores on Ambulation- Post Operative Day 2
|
3.2 score on a scale
Standard Deviation 1.0
|
3.1 score on a scale
Standard Deviation 2.57
|
|
Pain Scores
Pain Scores at rest- Post Operative Day 3
|
2.2 score on a scale
Standard Deviation 1.87
|
1.6 score on a scale
Standard Deviation 0.95
|
|
Pain Scores
Pain Scores on Ambulation- Post Operative Day 3
|
2.6 score on a scale
Standard Deviation 1.21
|
2.0 score on a scale
Standard Deviation 1.44
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post Operative Day 1, 2 & 3Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 \& 3)
Outcome measures
| Measure |
Bupivacaine
n=10 Participants
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
Liposomal Bupivacaine
n=13 Participants
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
|---|---|---|
|
Number of Patients Reporting Sleep Disturbance
Post Operative Day 1
|
3 Participants
|
4 Participants
|
|
Number of Patients Reporting Sleep Disturbance
Post Operative Day 2
|
3 Participants
|
3 Participants
|
|
Number of Patients Reporting Sleep Disturbance
Post Operative Day 3
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post Operative Day 1, 2 & 3Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)
Outcome measures
| Measure |
Bupivacaine
n=10 Participants
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
Liposomal Bupivacaine
n=13 Participants
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
|---|---|---|
|
Satisfaction With Pain Management
Post Operative Day 2
|
14.1 score on a scale
Standard Deviation 1.73
|
13.8 score on a scale
Standard Deviation 2.24
|
|
Satisfaction With Pain Management
Post Operative Day 3
|
14.6 score on a scale
Standard Deviation 0.97
|
14.0 score on a scale
Standard Deviation 2.22
|
|
Satisfaction With Pain Management
Post Operative Day 1
|
13.9 score on a scale
Standard Deviation 1.91
|
13.3 score on a scale
Standard Deviation 2.69
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
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
Sanjay Sinha, MD
Saint Francis Hospital and Medical Center
Phone: 860-714-6654
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place