Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

NCT05667324 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB202201279 -A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Deviated Nasal Septum

Keywords

Post-op pain; septorhinoplasty; deviated septum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post Anesthesia Care Unit Duration

  60-180 minutes

• Text Message Survey Collection

  5 days post-operatively +/- 1 day

Study Arms (2)

Group 1: Ropivacaine plus Dexamethasone

EXPERIMENTAL

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; Drug: Dexamethasone

Group 2: Placebo plus Dexamethasone

ACTIVE COMPARATOR

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; Drug: Placebo

Interventions

Ropivacaine DRUG

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

Group 1: Ropivacaine plus Dexamethasone

Dexamethasone DRUG

Plus 4 mg dexamethasone

Group 1: Ropivacaine plus Dexamethasone; Group 2: Placebo plus Dexamethasone

Placebo DRUG

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

Group 2: Placebo plus Dexamethasone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient presenting for open or endoscopic septorhinoplasty
• Age 18-80
• Normal oral food and water intake before surgery
• ASA physical classification 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Jeffrey Johnson
• Organization: University of Florida

Jeffrey.Johnson@ent.ufl.edu

317-439-7775

Study Officials

• Jeffrey D Johnson, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 28, 2022
• Study Start: April 12, 2023
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)