Preoperative Nerve Block for Rhinoplasty/Septoplasty

• Sponsor: University of Southern California (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03780478
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32.5
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Fracture; Deviated Nasal Septum	Drug: Nerve block; Drug: Placebo Saline Injection	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: rhinoplasty/septoplasty patients will be identified by Dr. Kochhar (PI). Patients' informed consent for participation in this study will be obtained and they will subsequently be enrolled. Participants will be randomized into two arms: experimental vs. placebo. Study arms: Experimental: SPG block with local anesthetic per normal methods of nerve block. Placebo: Injection of salinerhinoplasty/septoplasty patients will be identified by Dr. Kochhar (PI). Patients' informed consent for participation in this study will be obtained and they will subsequently be enrolled. Participants will be randomized into two arms: experimental vs. placebo.Study arms:Experimental: SPG block with local anesthetic per normal methods of nerve block. Placebo: Injection of saline
• Masking: Single (Participant)
• Masking Description: After giving consent to participate in study, patients enrolled in study will be randomly assigned to either the experimental vs. normal standard of care. Patients and members of care team will be unaware as to which group they are assigned.
• Primary Purpose: Treatment
• Official Title: Evaluation of a Preoperative Nerve Block in Pain Scores Following Rhinoplasty/Septoplasty
• Actual Study Start Date: Jun 17, 2019
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SPG Block Sphenopalatine ganglion block	Drug: Nerve block; 0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL
Placebo Comparator: Placebo Control Saline injection	Drug: Placebo Saline Injection; Saline injection, total volume 2ml

Outcome Measures

Primary Outcome Measures

1. Post op Narcotic Use [7 days]

   Amount of narcotic use in post operative phase will be recorded until follow up visit

2. Post op Numerical pain scale [7 days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Keck Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Amit Kochhar, MD, USC Keck Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

• 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.
• 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.
• Kesimci E, Öztürk L, Bercin S, Kırış 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.
• 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.

• Responsible Party: Amit Kochhar, Clinical Assistant Professor of Otolaryngology -Head & Neck Surgery, University of Southern California
• ClinicalTrials.gov Identifier: NCT03780478
• Other Study ID Numbers: Rhinoplasty Nerve Block Study
• First Posted: Dec 19, 2018
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jul 30, 2019