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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | A single injection into the pterygopalatine fossa bilaterally of 0.5% ropivacaine at a dose of 20 mg (each side) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 days +/- 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60-180 minutes |
| Text Message Survey Collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D Johnson, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health of University of Florida | Gainesville | Florida | 32610 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ropivacaine Plus 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 |
| FG001 | Group 2: Placebo Plus 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ropivacaine Plus 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | pain score on a scale of 0-10 | 5 days +/- 2 days |
|
from enrollment utnil end of follow up, up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Ropivacaine Plus 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Johnson | University of Florida | 317-439-7775 | Jeffrey.Johnson@ent.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2023 | Feb 22, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Dexamethasone | Drug | Plus 4 mg dexamethasone |
|
| Placebo | Drug | A single injection into the pterygopalatine fossa bilaterally of a balanced crystalloid intravenous solution (4 ml of normal saline) |
|
To assess the efficiency of SMS based survey for post-operative data collection |
| 5 days post-operatively +/- 1 day |
| BG001 | Group 2: Placebo Plus 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. |
| BG002 | Total | Total of all reporting groups |
| age (years) |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 |
| Group 2: Placebo Plus 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | minutes (60 - 180) | 60-180 minutes |
|
|
|
| Secondary | Text Message Survey Collection | To assess the efficiency of SMS based survey for post-operative data collection | Posted | Count of Participants | Participants | 5 days post-operatively +/- 1 day |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Group 2: Placebo Plus 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| Post operative day 5 |
|