Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Sponsor

University of Florida (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05667324

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Deviated Nasal Septum	Drug: Ropivacaine Drug: Dexamethasone Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Post-operative Pain Control With Sphenopalantine Ganglion Nerve Block in Septorhinoplasty Patients

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1: Ropivacaine plus Dexamethasone 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	Drug: Ropivacaine A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side) Drug: Dexamethasone Plus 4 mg dexamethasone
Active Comparator: Group 2: Placebo plus Dexamethasone 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.	Drug: Dexamethasone Plus 4 mg dexamethasone Drug: Placebo A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)

Arm

Intervention/Treatment

Experimental: Group 1: Ropivacaine plus Dexamethasone

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

Drug: Ropivacaine

A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)

Drug: Dexamethasone

Plus 4 mg dexamethasone

Active Comparator: Group 2: Placebo plus Dexamethasone

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.

Drug: Dexamethasone

Plus 4 mg dexamethasone

Drug: Placebo

A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)

Outcome Measures

Primary Outcome Measures

Decrease the opioid requirement post-operatively as assessed by providers. [7 days +/- 2 days]
post operative period

Secondary Outcome Measures

Decrease in post-anesthesia care unit observation time. [60-180 minutes]
PACU duration times
Efficiency of SMS based survey for post-operative data collection. [5 days post-operatively +/- 1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Jeffrey D Johnson, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT05667324

Other Study ID Numbers:

IRB202201279 -A

First Posted:

Dec 28, 2022

Last Update Posted:

Jan 17, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University of Florida

Post-op pain

septorhinoplasty

deviated septum

Additional relevant MeSH terms:

Pain, Postoperative

Dexamethasone

Ropivacaine

Study Results

No Results Posted as of Jan 17, 2023