Hip Injuries
Conditions
Keywords
Hip Arthroscopy, Liposomal Bupivacaine, Bupivacaine
Brief summary
This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours
Detailed description
Patients undergoing hip arthroscopy experience moderate to severe postoperative pain. Effective pain control after surgery is an important component in the overall management of these patients. Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction. Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications. Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.
Interventions
DRUGliposomal bupivacaine
(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy
DRUGBupivacaine
(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
Sponsors
Trinity Health Of New England
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients having hip arthroscopy
Exclusion criteria
* History of neurologic disease, neuropathy, diabetes * Allergy to local anesthetic solution * Chronic use of narcotics * Inability to give consent/cooperate with study * History of previous hip arthroscopy on the ipsilateral side * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 1, 2 & 3 | Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | Post Operative Day 1, 2 & 3 | Analysis 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Sleep Disturbance | Post Operative Day 1, 2 & 3 | Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 & 3) |
| Satisfaction With Pain Management | Post Operative Day 1, 2 & 3 | Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy | 10 |
| Liposomal Bupivacaine Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy | 13 |
| Total | 23 |
Baseline characteristics
| Characteristic | Bupivacaine | Liposomal Bupivacaine | Total |
|---|---|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 8.9 | 30.5 years STANDARD_DEVIATION 8.28 | 34.5 years STANDARD_DEVIATION 10.48 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3.
Time frame: Post Operative Day 1, 2 & 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 1 | 2.8 number of 5 mg oxycontin | Standard Deviation 1.87 |
| Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 2 | 2.7 number of 5 mg oxycontin | Standard Deviation 2 |
| Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 3 | 2.3 number of 5 mg oxycontin | Standard Deviation 2 |
| Liposomal Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 1 | 1.9 number of 5 mg oxycontin | Standard Deviation 1.5 |
| Liposomal Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 2 | 2.2 number of 5 mg oxycontin | Standard Deviation 2.34 |
| Liposomal Bupivacaine | Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Post Operative Day 3 | 0.9 number of 5 mg oxycontin | Standard Deviation 1.38 |
Secondary
Pain Scores
Analysis 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)
Time frame: Post Operative Day 1, 2 & 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 1 | 1.9 score on a scale | Standard Deviation 0.94 |
| Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 1 | 3.1 score on a scale | Standard Deviation 2.12 |
| Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 2 | 1.9 score on a scale | Standard Deviation 1.47 |
| Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 2 | 3.2 score on a scale | Standard Deviation 1 |
| Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 3 | 2.2 score on a scale | Standard Deviation 1.87 |
| Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 3 | 2.6 score on a scale | Standard Deviation 1.21 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 3 | 1.6 score on a scale | Standard Deviation 0.95 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 1 | 1.1 score on a scale | Standard Deviation 1.44 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 2 | 3.1 score on a scale | Standard Deviation 2.57 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 1 | 3.9 score on a scale | Standard Deviation 2.43 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores on Ambulation- Post Operative Day 3 | 2.0 score on a scale | Standard Deviation 1.44 |
| Liposomal Bupivacaine | Pain Scores | Pain Scores at rest- Post Operative Day 2 | 1.0 score on a scale | Standard Deviation 1.35 |
Other Pre-specified
Number of Patients Reporting Sleep Disturbance
Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 & 3)
Time frame: Post Operative Day 1, 2 & 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 1 | 3 Participants |
| Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 2 | 3 Participants |
| Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 3 | 1 Participants |
| Liposomal Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 3 | 0 Participants |
| Liposomal Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 1 | 4 Participants |
| Liposomal Bupivacaine | Number of Patients Reporting Sleep Disturbance | Post Operative Day 2 | 3 Participants |
Other Pre-specified
Satisfaction With Pain Management
Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)
Time frame: Post Operative Day 1, 2 & 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine | Satisfaction With Pain Management | Post Operative Day 3 | 14.6 score on a scale | Standard Deviation 0.97 |
| Bupivacaine | Satisfaction With Pain Management | Post Operative Day 1 | 13.9 score on a scale | Standard Deviation 1.91 |
| Bupivacaine | Satisfaction With Pain Management | Post Operative Day 2 | 14.1 score on a scale | Standard Deviation 1.73 |
| Liposomal Bupivacaine | Satisfaction With Pain Management | Post Operative Day 1 | 13.3 score on a scale | Standard Deviation 2.69 |
| Liposomal Bupivacaine | Satisfaction With Pain Management | Post Operative Day 2 | 13.8 score on a scale | Standard Deviation 2.24 |
| Liposomal Bupivacaine | Satisfaction With Pain Management | Post Operative Day 3 | 14.0 score on a scale | Standard Deviation 2.22 |