Septorhinoplasty Post-operative Pain Control With SPG Nerve Block
Phase 4
Recruiting
- Conditions
- Deviated Nasal Septum
- Interventions
- Registration Number
- NCT05667324
- Lead Sponsor
- University of Florida
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: Placebo plus Dexamethasone Placebo 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. Group 1: Ropivacaine plus Dexamethasone Ropivacaine 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 2: Placebo plus Dexamethasone Dexamethasone 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. Group 1: Ropivacaine plus Dexamethasone Dexamethasone 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
- Primary Outcome Measures
Name Time Method Decrease the opioid requirement post-operatively as assessed by providers. 7 days +/- 2 days post operative period
- Secondary Outcome Measures
Name Time Method Efficiency of SMS based survey for post-operative data collection. 5 days post-operatively +/- 1 day Decrease in post-anesthesia care unit observation time. 60-180 minutes PACU duration times
Trial Locations
- Locations (1)
UF Health of University of Florida
🇺🇸Gainesville, Florida, United States