Effect of a Pre-Operative Local Anesthetic Facial Block on Post-Operative Rhinoplasty Pain

Nasal Obstruction Clinical Trial

Official title: Effect of a Pre-Operative Local Anesthetic Facial Block on Post-Operative Rhinoplasty Pain

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The proposed study is a prospective longitudinal study that classifies as a randomized double-blind placebo control study given that patients are randomly allocated to either the group receiving the treatment under investigation (experimental group, receiving bupivacaine as outlined below) or to a control group (receiving a saline control injection). In this study, patients, study physicians, and research coordinator (study team) will be blinded as to which treatment group each patient is assigned given that the pharmacy will manage the randomization process. Moreover, this study constitutes a phase IV clinical trial because we are studying a drug that has already been approved by the FDA. We are looking at quantifying the effect of a local anesthetic, bupivacaine, on post-operative pain following rhinoplasty. In this study, we are using the drug for its stated clinical purpose - as a local anesthetic. In this way, this study does not constitute a phase I, II, or III clinical trial.

For this study, we plan to enroll Mass. Eye and Ear patients who present for cosmetic and/or functional rhinoplasty. Each qualifying patient will be presented with the study and consented should they choose to enroll. This study will consist of two arms; patients will be randomly assigned to one of two groups - either the experimental group, where patients receive an injection of bupivacaine to the infraorbital nerve, or a control group in which patients are injected with a saline solution to the same region.

A standardized pre-operative protocol will be followed to ensure that all patients receive standard of care. After each patient undergoes the surgical rhinoplasty procedure, they will be asked to report their pain scale, level of nausea, and use of oxycodone on day 0 (the day of the surgical operation). On day 0, a nurse in the Post-Anesthesia Care Unit will collect the aforementioned data points approximately once every hour and record them in Epic as part of standard protocol.

On post-operative days 1, 2, 3, and 8, a trained research coordinator will call each patient and use a standardized phone script to assess the same data points - pain scale, nausea, and use of oxycodone, as well as lip numbness at time of surgery (collected only at post-operative day 1). Taken together, this data will help establish whether a pre-operative local anesthetic facial block can improve post-operative pain and opioid usage among rhinoplasty patients. We plan to enroll 20 patients at MEEI in each arm of the study (40 patients total), among patients already scheduled to undergo a rhinoplasty procedure for cosmetic and/or functional reasons. ;

Related Conditions & MeSH terms

• Nasal Deformity, Acquired
• Nasal Obstruction
• Nose Deformities, Acquired

• NCT number: NCT03726723
• Study type: Interventional
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Linda Lee, MD
• Phone: 617-573-3709
• Email: linda_lee@meei.harvard.edu
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2018
• Completion date: November 2020