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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel TLIP Injection | Experimental | Subjects will receive 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine. A total of 30 mL of mixed solution is injected into the thoracolumbar interfacial plane. |
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| Bupivicaine HCL TLIP Injection | Active Comparator | Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection. Subjects will receive 30 mL of the solution, injected into the thoracolumbar interfacial plane. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion. | Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery. | 0-72 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postsurgical opioid consumption | The following data points will be recorded to further claim the investigators hypothesis of treatment with EXPAREL compared to Bupivacaine hydrochloride. • Total postsurgical opioid consumption in oral morphine equivalents (Oral morphine equivalents) from 0 to 76 hours post-surgery | 0-72 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Small, MD | Florida Orthopaedic Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33607 | United States |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Study subjects will be randomized to either Group 1 or Group 2 in a 1:1 ratio based on the randomization scheme in sealed envelopes maintained by the study coordinator.
| Bupivacain |
| Drug |
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL |
|
| Time to discharge | collect hours of hospital stay | 0-72 hours postoperatively |
| Time to ambulation | collect time ambulated from surgery | 0-72 hours postoperatively |
| Maximum ambulated distance | Physical Therapy will document the distance subject could ambulate after surgery | 0-72 hours postoperatively |
| Numeric Rating Pain Scale (Physical Therapy) | Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation) | 0-72 hours postoperatively |
| Numeric Rating Pain Scale | Numerical rating scale pain intensity scores at 24hour, 36hour, 60hour, and 72hour from the end of surgery and again at the first clinic visit postoperatively (scale of 0-10 with 0 indicates no pain and 10 severe pain) | 0-72 hours with additional follow-up at 14 days (first clinic visit) |
| Oswestry Disability Index (ODI) | 10 questions relating to function specific to low back pain given before surgery and collected at 14 day post op visit. | 0- 14 days postoperatively |
| Pain Catastrophizing Scale (PCS) | This scale measures thoughts and feelings that may be associated with pain. it is rated 0-5 with 0 indicating not at all, 1 indicating to a slight degree, 2 indicates a moderate degree, 3 indicates a great degree and 4 idicates all the time. There are 13 statements that are rated, the ratings are scored to determine where each subject falls in the scale. | 0-14 days postoperatively |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D000588 |
| Amines |