Nasal Obstruction Clinical Trial
Official title:
Effect of a Pre-Operative Local Anesthetic Facial Block on Post-Operative Rhinoplasty Pain
The specific aim of this study is to determine whether pre-operative treatment with a bupivacaine nerve block can influence post-operative pain and oxycodone usage among rhinoplasty patients. Specifically, we plan to directly compare the reported pain scale, nausea, and oxycodone usage among patients who received the bupivacaine block against those of patients in the saline control condition. These assessments will be documented on day 0 (day of operation) by a nurse in the Post-Anesthesia Care Unit, while the same data points will be collected over the phone by our clinical research coordinator on post-operative days 1, 2 , 3, and 8 following discharge.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | November 2020 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 89 Years |
Eligibility |
Inclusion Criteria: - Patients undergoing a rhinoplasty procedure for cosmetic and/or functional reasons - Patients between the ages of 15 and 89 Exclusion Criteria: - Patients on chronic opioids for any pain syndrome pre-operatively - Non-English speaking patients - Patients who are younger than 15 years of age and older than 89 years of age - Patients not undergoing rhinoplasty - Patients who are allergic to bupivacaine or related anesthteics - Patients who are pregnant |
Country | Name | City | State |
---|---|---|---|
United States | Mass Eye and Ear | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts Eye and Ear Infirmary |
United States,
Maimon WN, Schuller DE. Lidocaine v bupivacaine in facial plastic surgery. A clinical trial. Arch Otolaryngol. 1984 Aug;110(8):525-8. — View Citation
Maxwell JC. The prescription drug epidemic in the United States: a perfect storm. Drug Alcohol Rev. 2011 May;30(3):264-70. doi: 10.1111/j.1465-3362.2011.00291.x. — View Citation
Patel S, Sturm A, Bobian M, Svider PF, Zuliani G, Kridel R. Opioid Use by Patients After Rhinoplasty. JAMA Facial Plast Surg. 2018 Jan 1;20(1):24-30. doi: 10.1001/jamafacial.2017.1034. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison between patient-reported pain score on post-operative day 1, among control patients and bupivacaine-treated patients. | Change in pain score compared between patients in control condition and patients in bupivacaine condition - at post-operative day 1. Given that Marcaine (with half-life of 2.7 hours) begins to wear off approximately 8 hours after initial administration, we are particularly interested in this post-operative time point. This primary endpoint is based on the associated primary outcome of this study - related to a change in pain score between bupivacaine-treated patients and patients in the control condition. | day 0 to post-operative day 1 | |
Secondary | Comparison between patient-reported pain score on post-operative days 2, 3, and 8 | In addition to studying the difference in pain score at post-operative day 1 between bupivacaine and control patients, we are interested in drawing the same comparison at post-operative days 2, 3, and 8 - and therefore submit these as secondary endpoints related to secondary study outcomes. | day 0 to post-operative day 8 | |
Secondary | Comparison of opioid usage between bupivacaine-treated and control patients at all post-operative time points | We plan to compare opioid usage across the two groups - control and bupivacaine-treated - at post-operative days 0, 1, 2, 3, and 8. We submit these as secondary outcome measures as we are primarily interested in post-operative pain assessment after rhinoplasty. | day 0 to post-operative day 8 |
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