Pain Management in Response to Exparel vs. Standard Bupivicaine (VATS Exparel)
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|ClinicalTrials.gov Identifier: NCT02499159|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : February 13, 2018
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Liposomal Bupivicaine Drug: 0.25% standard bupivicaine||Phase 4|
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
Drug: Liposomal Bupivicaine
266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
Other Name: Exparel
Active Comparator: 0.25% standard bupivicaine
Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
Drug: 0.25% standard bupivicaine
standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Other Name: Bupivicaine
- Overall Amounts of Pain Medications Consumed through Post-operative Day 7 [ Time Frame: Assessed daily for 7 days post-procedure ]Using questionnaires, patients are asked if they took Dilaudid, Tylenol, or Motrin, and if so, how many tablets.
- Analog Pain Scores [ Time Frame: Assessed daily for 7 days post-procedure, and again at 30 days post-procedure ]Using questionnaires, patients are asked what their pain level is based on a scale from 0-10.
- Incidence of Paresthesias [ Time Frame: Assessed at day 7 and again at day 30 post-procedure ]Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves
- Hospital Length of Stay [ Time Frame: From end of procedure until discharge, usually 0-2 days. ]Length of stay in days until discharge, usually 0-2 days.
- Return to Baseline Activity [ Time Frame: Assessed at 30 days post-procedure ]Using surveys, patients are asked if they have been able to return to baseline activity levels.
- Return to Work [ Time Frame: Assessed at 30 days post-procedure ]Using surveys, patients are asked if they have been able to return to work and, if so, how many days it took to return to work.
- Overall Hospital Cost [ Time Frame: Total cost assessed from patient registration until discharge to home (usually 0-2 days). ]Overall hospital cost of patient procedure and stay will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499159
|United States, Virginia|
|Cardiac, Vascular, and Thoracic Surgery Associates|
|Falls Church, Virginia, United States, 22042|
|Inova Fairfax Hospital|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Sandeep J Khandhar, MD||Cardiac, Vascular, and Thoracic Surgery Associates|