Preoperative Nerve Block for Rhinoplasty/Septoplasty

Deviated Nasal Septum Clinical Trial

Official title:

Evaluation of a Preoperative Nerve Block in Pain Scores Following Rhinoplasty/Septoplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03780478
• Other study ID #: Rhinoplasty Nerve Block Study
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: June 17, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Addiction is an inherent risk when prescribing opiates for pain relief, and methods to reduce its use or amount prescribed can help mitigate this risk for addiction. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Studies have shown intraoperative sphenopalatine ganglion (SPG) nerve block in endoscopic sinus surgery can reduce post operative narcotic use. The purpose of this study is to determine if use of SPG block can be used to reduce narcotic use in the acute post operative phase of rhinoplasty/septoplasty.

Description:

With the current opioid epidemic, more than 40,000 deaths can be attributed to prescription and illicit opioid use per year. There is inherent risk for patients to develop addiction when prescribing opiates for pain relief, and methods to reduce its use or the amount prescribed can help mitigate this risk.

Surgery is one of the leading causes for prescribing narcotics to control pain. Patients undergoing rhinoplasty are often prescribed a short course of opiates during the acute post surgical phase. Intraoperative sphenopalatine ganglion (SPG) block has been successfully and safely used in endoscopic sinus surgery, and has been shown to decrease narcotic use and inpatient hospital stay time.

The investigators are interested in determining if use of SPG block may offer an improved strategy to reducing the use of narcotics for post rhinoplasty/septoplasty pain relief. The investigators hypothesize that SPG block will reduce the amount of post operative opiates required for pain control.

The study population will include patients undergoing rhinoplasty/septoplasty at Keck Medical Center of USC who are able to provide consent. The study will include two arms: SPG block (experimental) and placebo saline injection (control). Patients' post operative pain scale and narcotic use will be recorded until first follow-up visit (2 weeks). Patient demographics, surgical indication, and intraoperative analgesia will be recorded. T-tests will be conducted between patient groups. ANOVA will be used to analyze other factors that may be associated with decreased narcotic use.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Any patient requiring rhinoplasty/septoplasty and able to provide consent.

2. Must be willing to participate.

3. Must be able to complete consent in English or Spanish.

Exclusion Criteria:

1. History of opioid substance abuse disorder.

2. <18 years old

3. Currently pregnant

Related Conditions & MeSH terms

• Deviated Nasal Septum
• Nasal Fracture

Intervention

Drug:
• Nerve block
0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL
• Placebo Saline Injection
Saline injection, total volume 2ml

Locations

Country	Name	City	State
United States	Keck Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (4)

Al-Qudah M. Endoscopic sphenopalatine ganglion blockade efficacy in pain control after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):334-8. doi: 10.1002/alr.21644. Epub 2015 Sep 15. — View Citation

DeMaria S Jr, Govindaraj S, Chinosorvatana N, Kang S, Levine AI. Bilateral sphenopalatine ganglion blockade improves postoperative analgesia after endoscopic sinus surgery. Am J Rhinol Allergy. 2012 Jan-Feb;26(1):e23-7. doi: 10.2500/ajra.2012.26.3709. — View Citation

Kesimci E, Öztürk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8. — 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	Post op Narcotic Use	Amount of narcotic use in post operative phase will be recorded until follow up visit	7 days
Primary	Post op Numerical pain scale	Pain scale will be recorded daily until follow up visit. Pain scale is defined as 0-10, where 0 is no pain, and 10 is worst pain ever experienced. Pain score will be obtained daily, and experimental arm will be compared with control arm.	7 days

External Links

•   6) National Institue on Drug Abuse. Overdose Death Rates. NIDA.
•   Role of Intraoperative Endoscopic Sphenopalatine Ganglion Block in Sinonasal Surgery