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SPG Nerve Block for Postoperative Pain
Phase 4
Recruiting
Led By Jeffrey D Johnson, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ASA physical classification 1-3
Age 18-80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-180 minutes
Awards & highlights
Study Summary
This trial will test if a nerve block can safely reduce pain after sinus surgery and reduce opioid usage.
Who is the study for?
This trial is for adults aged 18-80 who are undergoing septorhinoplasty, can eat and drink normally before surgery, and have a physical status classified as ASA 1-3. It's not for those allergic to opioids, with chronic pain or ongoing opioid use, needing additional surgeries, pregnant women, without mobile texting capabilities, or deemed unsuitable by the study team.Check my eligibility
What is being tested?
The study tests if nerve blocks in the pterygopalatine fossa using Ropivacaine and Dexamethasone reduce post-operative pain and opioid use after septorhinoplasty compared to a placebo. This randomized double-blind trial hypothesizes less pain and morbidity with this technique.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, potential numbness in the area due to nerve blockage, allergic reactions to medications used (Ropivacaine or Dexamethasone), and general risks associated with anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderately impaired.
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I am between 18 and 80 years old.
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I am planning to undergo nose surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-180 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-180 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Decrease the opioid requirement post-operatively as assessed by providers.
Secondary outcome measures
Decrease in post-anesthesia care unit observation time.
Efficiency of SMS based survey for post-operative data collection.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1: Ropivacaine plus DexamethasoneExperimental Treatment2 Interventions
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
Group II: Group 2: Placebo plus DexamethasoneActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,526 Total Patients Enrolled
Jeffrey D Johnson, MDPrincipal InvestigatorUniversity of Florida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need another surgery besides septorhinoplasty.If the study team thinks that you are not a good fit for the treatment, you will not be able to participate.I am either older than 80 or younger than 18.I am allergic to opioid pain medications.My health is severely limited by my illness.I have been using opioids for chronic pain for the last 3 months.My health is good to moderately impaired.I am between 18 and 80 years old.I am planning to undergo nose surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: Ropivacaine plus Dexamethasone
- Group 2: Group 2: Placebo plus Dexamethasone
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians admissible for this research trial?
"Prospective participants in this trial must range from 18 to 80 years old. Separately, there are 65 studies that accept minors and 401 for seniors."
Answered by AI
What adverse effects may arise from the administration of Group 1: Ropivacaine plus Dexamethasone?
"Our experts at Power have assigned a safety rating of 3 to Group 1: Ropivacaine plus Dexamethasone, as it is an approved medical intervention in Phase 4 trials."
Answered by AI
How many participants have enlisted in this experiment?
"Yes, the information posted on clinicaltrials.gov suggests that this trial is actively looking for participants. It was first listed on March 30th 2023 and has been recently refreshed on May 25th of the same year. The team behind it require 120 individuals to be recruited from just one site."
Answered by AI
Are there any vacancies available for participants in this research trial?
"Affirmative, clinicaltrials.gov provides evidence that this medical trial is actively seeking participants. First posted on March 30th 2023 and updated May 25th of the same year, the study needs 120 volunteers from a single site."
Answered by AI
Am I a suitable candidate for participating in this experiment?
"This clinical trial is seeking 120 individuals, from ages 18 to 80, with deviated nasal septum. In addition to the age range and health issue criteria mentioned above, participants must be able to consume oral food and water normally before surgery and have an ASA physical classification of 1-3."
Answered by AI
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