Deviated Nasal Septum
Conditions
Keywords
Post-op pain, septorhinoplasty, deviated septum
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.
Interventions
DRUGRopivacaine
A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side)
DRUGDexamethasone
Plus 4 mg dexamethasone
DRUGPlacebo
A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline)
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Scores | 5 days +/- 2 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Anesthesia Care Unit Duration | 60-180 minutes | 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. |
| Text Message Survey Collection | 5 days post-operatively +/- 1 day | To assess the efficiency of SMS based survey for post-operative data collection |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJeffrey D Johnson, MD
University of Florida
Participant flow
Pre-assignment details
Once participants met inclusion and exclusion criteria, and consented to participate in the study, they were assigned to 1 of 2 study arms, experimental arm or placebo arm.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 40.1 age (years) STANDARD_DEVIATION 15.9 |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 24 |
| other Total, other adverse events | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 22 | 0 / 24 |
Outcome results
None listed