Liposomal Bupivacaine (Exparel) in Sarcomas
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|ClinicalTrials.gov Identifier: NCT03867188|
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Soft Tissue Tumor Soft Tissue Tumor and/or Sarcoma||Drug: Liposomal Bupivacaine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Experimental: Liiposomal Bupivacaine Group
Qualified participants with a soft tissue sarcoma of the thigh will be given the alternative protocol utilizing liposomal bupivacaine (Exparel®). The alternative protocol will utilize general or spinal anesthesia, but will also include the use of intraoperative liposomal bupivacaine instead of a regional nerve block.
Drug: Liposomal Bupivacaine
A 25 gauge or larger bore needle will be used to inject the liposomal bupivacaine at the site of operation following the prescription guidelines provided by Exparel®. The maximum dose allowable for this study is 266mg or 20 mL as indicated in the FDA package insert.
Other Name: Exparel
No Intervention: Control Group
A retrospective control group will be assembled from electronic medical records of 3 patients who underwent resection of a soft tissue sarcoma of the thigh and will be accessed and analyzed for the variable of interest.
- Number of participants with peak pain scores measured by VAS less than 7 [ Time Frame: Up to 24 hours ]Feasibility of Exparel for post surgical pain management in soft-tissue sarcoma surgeries of the thigh will be defined as peak pain score measured by VAS (Visual Analogue Scale) less than 7. VAS scores range 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
- Peak Pain Scores during hospital stay post surgery [ Time Frame: Up to 5 days ]Peak pain scores will be measured by VAS (Visual Analogue Scale) which is printed on the Post-Operative Pain and Medication Administration questionnaire. VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
- Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME) [ Time Frame: Up to 5 days ]The opioid medications that the subject uses will be recorded and the data regarding total narcotic usage will be converted to MME to maintain a standard unit for the study.
- Number of surgical-related infection [ Time Frame: 6 week post surgery ]Number of surgical-related infection will be documented by use of Treatment Follow-Up Form and Adverse Event Log.
- Average Pain Scores during hospitalization [ Time Frame: up to 5 days ]Average pain scores will be measured by VAS (Visual Analogue Scale). VAS ranges 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
- Length of time in hospital [ Time Frame: End of hospitalization (up to 30 days) ]The unit of time used to record length of stay will be days. Defined as the time from entry into the post anesthesia care unit (PACU) to discharge
- Rate of approached and consented patients [ Time Frame: end of the study up to 2 years ]The rate will be calculated with the number of participants that consented divided by the number of patients approached about the study
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): NCT03867188
|Contact: Debra Bullardfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest University Health Sciences||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Debra Bullard 336-716-9877 email@example.com|
|Principal Investigator: Cynthia L Emory, MD|
|Sub-Investigator: Carl Edge, B.S.|
|Sub-Investigator: Donald J Scholten, MD|
|Principal Investigator:||Cynthia L Emory, MD||Wake Forest University Health Sciences|