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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Experimental | Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy |
|
| Bupivacaine | Active Comparator | Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivacaine | Drug | (Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) | Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3. | Post Operative Day 1, 2 & 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Post Operative Day 1, 2 & 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Post Operative Day 1, 2 & 3 |
| Satisfaction With Pain Management |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Sinha, MD | Saint Francis Hospital and Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Ultrasound guided injection of liposomal bupivacaine liposomal bupivacaine: (Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine | Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy |
| BG001 | Liposomal Bupivacaine | Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | number of 5 mg oxycontin | Post Operative Day 1, 2 & 3 |
|
Adverse events were collected until post operative day 3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | Ultrasound guided injection of liposomal bupivacaine liposomal bupivacaine: (Ultrasound guided injection of liposomal bupivacaine) |
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Study was terminated early leading to limited number of study subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay Sinha, MD | Saint Francis Hospital and Medical Center | 860-714-6654 | ssinha3300@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2013 | Jun 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy |
|
|
Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)
| Post Operative Day 1, 2 & 3 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Post Operative Day 1, 2 & 3 |
|
|
|
| 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) | Posted | Count of Participants | Participants | Post Operative Day 1, 2 & 3 |
|
|
|
| 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) | Posted | Mean | Standard Deviation | score on a scale | Post Operative Day 1, 2 & 3 |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Bupivacaine | Bupivacaine (around the anterior, lateral and medial aspect of hip joint) Bupivacaine: (around the anterior, lateral and medial aspect of hip joint) | 0 | 10 | 0 | 10 | 0 | 10 |
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| D000588 |
| Amines |
| Pain Scores at rest- Post Operative Day 2 |
|
| Pain Scores on Ambulation- Post Operative Day 2 |
|
| Pain Scores at rest- Post Operative Day 3 |
|
| Pain Scores on Ambulation- Post Operative Day 3 |
|
| Post Operative Day 3 |
|
| Post Operative Day 3 |
|