Septorhinoplasty Post-operative Pain Control With SPG Nerve Block

Study Overview
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Brief Summary
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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.

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

Conditions
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Deviated Nasal Septum

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Ropivacaine plus Dexamethasone<br>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<br>* A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)<br>Drug: Dexamethasone<br>* Plus 4 mg dexamethasone<br>|
| Active Comparator: Group 2: Placebo plus Dexamethasone<br>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<br>* Plus 4 mg dexamethasone<br>Drug: Placebo<br>* A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease the opioid requirement post-operatively as assessed by providers. | post operative period | 7 days +/- 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in post-anesthesia care unit observation time. | PACU duration times | 60-180 minutes | 
| Efficiency of SMS based survey for post-operative data collection. |  | 5 days post-operatively +/- 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-op pain, septorhinoplasty, deviated septum