Clinical trial NCT03780478: Preoperative Nerve Block for Rhinoplasty/Septoplasty
Official title: Evaluation of a Preoperative Nerve Block in Pain Scores Following Rhinoplasty/Septoplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nasal Fracture
Deviated Nasal Septum
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:

1. Experimental: SPG block with local anesthetic per normal methods of nerve block.
2. Placebo: Injection of saline
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post op Narcotic Use
timeFrame: 7 days
measure: Post op Numerical pain scale
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medical Center
state: California
Study officials:
affiliation: USC Keck Medical Center
name: Amit Kochhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Kesimci E, Ozturk 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.
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.