Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Deviated Nasal Septum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667324
• Other study ID #: IRB202201279 -A
• Status: Recruiting
• Phase: Phase 4
• Start date: April 12, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Jeffrey D Johnson, MD
• Phone: 352-273-5199
• Email: jeffrey.johnson[@]ent.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deviated Nasal Septum
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine
A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)
• Dexamethasone
Plus 4 mg dexamethasone
• Placebo
A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)

Locations

Country	Name	City	State
United States	UF Health of University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease the opioid requirement post-operatively as assessed by providers.	post operative period	7 days +/- 2 days
Secondary	Decrease in post-anesthesia care unit observation time.	PACU duration times	60-180 minutes
Secondary	Efficiency of SMS based survey for post-operative data collection.		5 days post-operatively +/- 1 day