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This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign.
Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups.
Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Operative: Continuous ropivacaine via Ambit pump | Experimental | Postoperatively, infusion pump reservoirs will contain 0.20% ropivacaine and infused via the Ambit pump (8cc/hr for knees, 6cc/hr for shoulders). |
|
| Pre-Operative: Liposomal bupivacaine (Exparel) | Active Comparator | A single-shot of Liposomal Bupivicaine (Exparel) will be administered pre-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 0.5% Injectable Solution | Drug | Preoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period | Compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. NPRS score difference of approximately 1.5 +/- 1 (approximately 2 points) to detect clinically significant difference in pain score. | Postoperative days 0, 1,2,3,4,7,10, 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups | use of narcotic and other analgesic pain medication throughout the 14 day postoperative period | Postoperative period through day 14 |
| Safety Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles Gatt, MD | Contact | 732-537-0909 | cjgatt85@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Center for Ambulatory Surgery | Recruiting | Somerset | New Jersey | 08873 | United States |
All of the individual participant data collected during the trail, after deidentification.
Immediately following publication. No end date.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 4 week time increments across the study recruitment period.
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|
| Ropivacaine 0.2% Injectable Solution | Drug | Post-operative continuous infusion |
|
| 1.3% liposomal bupivacaine (Exparel) | Drug | Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel) |
|
| ambIT Infusion Pump | Device | A pain pump provides intermittent delivery of medication to manage post-surgery pain. |
|
Evaluate the rates of catheter site infection, extravasation, pump malfunction
| Postoperative period through day 14 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |