Deviated Nasal SeptumPhase 4NCT05667324
Septorhinoplasty Post-operative Pain Control With SPG Nerve Block
A Phase 4 study testing Ropivacaine and Dexamethasone in people with Deviated Nasal Septum, run by University of Florida at 1 site in United States.
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 sphenopalatine ganglion using a suprazygomatic approach during… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Deviated Nasal Septum
- What is being tested?
- Ropivacaine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to 28 Feb 2025
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting for open or endoscopic septorhinoplasty
- Age 18-80
- Normal oral food and water intake before surgery
- ASA physical classification 1-3
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health of University of Florida
Gainesville, Florida, 32610
About this study
Official title: 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.
- Conditions
- Deviated Nasal Septum
- Being tested
- Ropivacaine, Dexamethasone, Placebo
- Keywords
- Post-op pain, septorhinoplasty, deviated septum
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)
DexamethasoneDrug
Plus 4 mg dexamethasone
PlaceboDrug
A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Dexamethasone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days +/- 2 days
Secondary outcomes (2)
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.
Measured: 60-180 minutes
Text Message Survey Collection
To assess the efficiency of SMS based survey for post-operative data collection
Measured: 5 days post-operatively +/- 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start12 Apr 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Deviated Nasal SeptumStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey D Johnson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667324
- Sponsor's protocol ID
- IRB202201279 -A
- Status last verified
- Aug 2025
- First submitted
- 4 Nov 2022
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No