Trial Outcomes & Findings for Septorhinoplasty Post-operative Pain Control With SPG Nerve Block (NCT NCT05667324)
NCT ID: NCT05667324
Last Updated: 2026-04-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
5 days +/- 2 days
Results posted on
2026-04-27
Participant Flow
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
did not respond to survey (non-respondant)
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: Ropivacaine Plus Dexamethasone
n=22 Participants
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
n=24 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
40.1 age (years)
STANDARD_DEVIATION 16.8 • n=22 Participants
|
40.1 age (years)
STANDARD_DEVIATION 15.5 • n=24 Participants
|
40.1 age (years)
STANDARD_DEVIATION 15.9 • n=46 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=22 Participants
|
17 Participants
n=24 Participants
|
27 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=22 Participants
|
7 Participants
n=24 Participants
|
19 Participants
n=46 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 5 days +/- 2 daysTo 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.
Outcome measures
| Measure |
Group 1: Ropivacaine Plus Dexamethasone
n=22 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Post Operative Pain Scores
Post operative day 1
|
3.9 pain score on a scale of 0-10
Standard Deviation 1.6
|
3.8 pain score on a scale of 0-10
Standard Deviation 2.1
|
|
Post Operative Pain Scores
Post operative day 3
|
2.7 pain score on a scale of 0-10
Standard Deviation 1.7
|
2.9 pain score on a scale of 0-10
Standard Deviation 2.1
|
|
Post Operative Pain Scores
Post operative day 5
|
1.5 pain score on a scale of 0-10
Standard Deviation 1.7
|
2.1 pain score on a scale of 0-10
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 60-180 minutesTo 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.
Outcome measures
| Measure |
Group 1: Ropivacaine Plus Dexamethasone
n=22 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Post Anesthesia Care Unit Duration
|
111 minutes (60 - 180)
Standard Deviation 63.5
|
108 minutes (60 - 180)
Standard Deviation 54.7
|
SECONDARY outcome
Timeframe: 5 days post-operatively +/- 1 dayTo assess the efficiency of SMS based survey for post-operative data collection
Outcome measures
| Measure |
Group 1: Ropivacaine Plus Dexamethasone
n=22 Participants
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
n=24 Participants
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.
|
|---|---|---|
|
Text Message Survey Collection
Post operative day 1
|
22 Participants
|
24 Participants
|
|
Text Message Survey Collection
Post operative day 3
|
18 Participants
|
23 Participants
|
|
Text Message Survey Collection
Post operative day 5
|
16 Participants
|
15 Participants
|
Adverse Events
Group 1: Ropivacaine Plus Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Placebo Plus Dexamethasone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place