Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

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

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 sphenopalatine ganglion 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.

Study Overview

• Status: Completed
• Conditions: Deviated Nasal Septum
• Intervention / Treatment: Drug: Ropivacaine; Drug: Dexamethasone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health of University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain Scores	To assess if bilateral sphenopalatine nerve blocks can decrease post operative pain scores on a scale from 0-10, with a 0 meaning no pain and 10 meaning extreme pain. Pain scores were assessed on post operative days 1, 3 and 5.	5 days +/- 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Anesthesia Care Unit Duration	To assess if bilateral sphenopalatine nerve blocks results in decreased post-anesthesia care unit observation time (assessed in minutes). Patients are transferred to the post-anesthesia care units immediately following completion of surgery.	60-180 minutes
Text Message Survey Collection	To assess the efficiency of SMS based survey for post-operative data collection	5 days post-operatively +/- 1 day

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Jeffrey D Johnson, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: septorhinoplasty; Post-op pain; deviated septum
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Ropivacaine; Dexamethasone
• Other Study ID Numbers: IRB202201279 -A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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