Foot and Ankle Clinic Application for Liposomal Related Anesthetic
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|ClinicalTrials.gov Identifier: NCT02586077|
Recruitment Status : Completed
First Posted : October 26, 2015
Last Update Posted : February 9, 2017
The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.
Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.
|Condition or disease||Intervention/treatment||Phase|
|Ankle Arthrodesis Hindfoot Arthrodesis Tibitalocalceal Arthrodesis||Drug: Exparel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Foot and Ankle Clinic Application for Liposomal Related Anesthetic|
|Study Start Date :||February 1, 2014|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||November 15, 2016|
Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.
- Amount of Narcotic Use [ Time Frame: Surgery to post operative day 3 ]
- Visual Analog Scale of pain (0-10) [ Time Frame: pre-operative to post operative day 3 ]pre-operatively, post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3
- Anti-emetic use [ Time Frame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3) ]Amount of anti-emetic use between the admission in the post anesthesia care unit through hospital discharge
- Patient Satisfaction Questionnaire regarding post surgical pain relief [ Time Frame: Measured at hospital discharge (on post operative day 3) and at first scheduled clinic post-operative visit, usually at 14 days after surgery ]
- Complications [ Time Frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery ]Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery.
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): NCT02586077
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28203|
|Study Director:||Susan M Odum, PhD||OrthoCarolina Research Institute|
|Principal Investigator:||Bruce Cohen, MD||OrthoCarolina Foot & Ankle Institute|