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Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Primary Purpose

Deviated Nasal Septum

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Dexamethasone
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deviated Nasal Septum focused on measuring Post-op pain, septorhinoplasty, deviated septum

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient presenting for open or endoscopic septorhinoplasty Age 18-80 Normal oral food and water intake before surgery ASA physical classification 1-3 Exclusion Criteria: Refusal to consent Patients without a cellular phone or who are unable to accept text messages Allergy to opioid narcotics ASA physical classification of 4 or higher Patient requires other surgery in addition to septorhinoplasty Age > 80 or <18 Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement. Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation. Pregnant women

Sites / Locations

  • UF Health of University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Ropivacaine plus Dexamethasone

Group 2: Placebo plus Dexamethasone

Arm Description

The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally

In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.

Outcomes

Primary Outcome Measures

Decrease the opioid requirement post-operatively as assessed by providers.
post operative period

Secondary Outcome Measures

Decrease in post-anesthesia care unit observation time.
PACU duration times
Efficiency of SMS based survey for post-operative data collection.

Full Information

First Posted
November 4, 2022
Last Updated
May 26, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05667324
Brief Title
Septorhinoplasty Post-operative Pain Control With SPG Nerve Block
Official Title
Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Maxillary nerve blocks have been shown to significantly reduce post-operative pain and analgesic intake during the 24-hour period following sinus surgery. This randomized, double-blinded, placebo-controlled study will investigate blocks of the pterygopalatine fossa using a suprazygomatic approach during septorhinoplasty surgery. It is the investigator's hypothesis that this technique will result in decreased post-operative pain and opioid use, and the morbidity associated with it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deviated Nasal Septum
Keywords
Post-op pain, septorhinoplasty, deviated septum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Ropivacaine plus Dexamethasone
Arm Type
Experimental
Arm Description
The group 1 injection procedure will be performed as follows: after preparation of the skin using appropriate skin preparation solution and using aseptic technique, a small-gauge spinal needle will be advanced into the pterygopalatine fossa under ultrasound guidance. Once the needle is properly positioned, 0.5% ropivacaine will be administered at a dose of 20 mg plus 4 mg dexamethasone and the needle will be removed. This procedure will be performed bilaterally
Arm Title
Group 2: Placebo plus Dexamethasone
Arm Type
Active Comparator
Arm Description
In group 2 the same procedure will be performed, but the injectate will consist of 5 mL of a balanced crystalloid intravenous solution (4 ml of normal saline) plus 4 mg dexamethasone (each side). This procedure will be performed bilaterally.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Plus 4 mg dexamethasone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)
Primary Outcome Measure Information:
Title
Decrease the opioid requirement post-operatively as assessed by providers.
Description
post operative period
Time Frame
7 days +/- 2 days
Secondary Outcome Measure Information:
Title
Decrease in post-anesthesia care unit observation time.
Description
PACU duration times
Time Frame
60-180 minutes
Title
Efficiency of SMS based survey for post-operative data collection.
Time Frame
5 days post-operatively +/- 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presenting for open or endoscopic septorhinoplasty Age 18-80 Normal oral food and water intake before surgery ASA physical classification 1-3 Exclusion Criteria: Refusal to consent Patients without a cellular phone or who are unable to accept text messages Allergy to opioid narcotics ASA physical classification of 4 or higher Patient requires other surgery in addition to septorhinoplasty Age > 80 or <18 Any underlying chronic pain condition or ongoing opioid use over the preceding 3 months Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement. Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation. Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey D Johnson, MD
Phone
352-273-5199
Email
jeffrey.johnson@ent.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cameron R Smith, MD, PhD
Email
csmith@anest.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey D Johnson, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health of University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

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