NCT03780478

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

December 17, 2018

Last Update Submit

July 28, 2019

Conditions

Nasal FractureDeviated Nasal Septum

Outcome Measures

Primary Outcomes (2)

  • Post op Narcotic Use

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

    7 days

  • 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

Study Arms (2)

SPG Block

EXPERIMENTAL

Sphenopalatine ganglion block

Drug: Nerve block

Placebo Control

PLACEBO COMPARATOR

Saline injection

Drug: Placebo Saline Injection

Interventions

Nerve blockDRUG

0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL

SPG Block
Placebo Saline InjectionDRUG

Saline injection, total volume 2ml

Placebo Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient requiring rhinoplasty/septoplasty and able to provide consent.
  • Must be willing to participate.
  • Must be able to complete consent in English or Spanish.

You may not qualify if:

  • History of opioid substance abuse disorder.
  • \<18 years old
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck Medical Center

Los Angeles, California, 90033, United States

Location

Related 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.

    PMID: 26370724BACKGROUND

  • 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.

    PMID: 22391074BACKGROUND

  • 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.

    PMID: 21739090BACKGROUND

  • 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.

    PMID: 29121158BACKGROUND

Related Links

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Amit Kochhar, MD

    USC Keck Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor of Otolaryngology -Head & Neck Surgery

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 19, 2018

Study Start

June 17, 2019

Primary Completion

December 31, 2021

Study Completion

March 1, 2022

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)