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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03726723
• Other study ID #: 1332715
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2018
• Est. completion date: November 2020

Study information

• Verified date: October 2018
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Linda Lee, MD
• Phone: 617-573-3709
• Email: linda_lee[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bupivacaine Hcl 0.75% Inj
For patients in the bupivacaine condition -- 'Bupivacaine Hcl 0.75% Inj' will be injected to the location of the infraorbital nerve in the supra-periosteal plane - 1.5 CCs per side.

Other:
• Saline
For control patients -- standard injectable saline will be injected also at 1.5 CCs per side to the same region. The MEEI Research Pharmacy will oversee the randomization process to ensure that the study is indeed double-blinded.

Locations

Country	Name	City	State
United States	Mass Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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