Intraoperative Bleeding
Conditions
Brief summary
In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.
Interventions
DRUGEpinephrin
Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity
DRUG1% lidocaine with epinephrin 1:100,000
4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)
DRUGSaline
4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery
Exclusion criteria
* Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2) * Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis * Patients with underlying uncontrolled hypertension * Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery * Patients who are allergic to adrenaline or to xylocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Field Grading Score | postoperatively (approximately 20 minutes to assess) | The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Extra Pledgets Used | intraoperatively (up to 3 hours) | A pledget is a small wad of absorbent material used to stop bleeding. |
| Estimated Blood Loss During Surgery | intraoperatively (up to 3 hours) | — |
| Duration of Surgery | intraoperatively (up to 3 hours) | — |
| Number of Days With Postoperative Bloody Nasal Discharge | 1 week after the surgery (up to 2 minutes to complete assessment) | Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire. |
| Number of Nostrils With Continuous Fresh Bleeding | 1 week after the surgery (up to 2 minutes to complete assessment) | Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes. |
| Postoperative Bloody Discharge Grading Score | 1 week after the surgery (up to 2 minutes to complete assessment) | Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants receive topical 1:1000 epinephrine plus saline in one nostril, and topical 1:1000 epinephrine plus infiltration of 1% lidocaine with 1:100,000 epinephrine in the other nostril. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Investigator Decision | 3 | 3 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Continuous | 49.46 years STANDARD_DEVIATION 16.34 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 Participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Surgical Field Grading Score
The video recording of the endoscopic sinus surgery of the participant was graded by another otolaryngology specialist postoperatively and graded according to Wormald Surgical Field Grading Scale. Scores range from 0 (no bleeding) to 10 (severe bleeding with nasal cavity filling rapidly).
Time frame: postoperatively (approximately 20 minutes to assess)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Surgical Field Grading Score | 3.54 score on a scale | Standard Deviation 0.96 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Surgical Field Grading Score | 3.23 score on a scale | Standard Deviation 1.14 |
p-value: 0.77t-test, 2 sided
Secondary
Duration of Surgery
Time frame: intraoperatively (up to 3 hours)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Duration of Surgery | 72.05 minutes | Standard Deviation 35.74 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Duration of Surgery | 54.23 minutes | Standard Deviation 22.27 |
p-value: 0.002t-test, 2 sided
Secondary
Estimated Blood Loss During Surgery
Time frame: intraoperatively (up to 3 hours)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Estimated Blood Loss During Surgery | 95.25 mL | Standard Deviation 82.88 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Estimated Blood Loss During Surgery | 91.63 mL | Standard Deviation 86.98 |
Secondary
Number of Days With Postoperative Bloody Nasal Discharge
Participants indicated number of days with bloody nasal discharge postoperatively using the 1-week postoperative bleeding questionnaire.
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Number of Days With Postoperative Bloody Nasal Discharge | 2.85 days | Standard Deviation 2.54 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Number of Days With Postoperative Bloody Nasal Discharge | 2.73 days | Standard Deviation 2.35 |
p-value: 0.418t-test, 2 sided
Secondary
Number of Extra Pledgets Used
A pledget is a small wad of absorbent material used to stop bleeding.
Time frame: intraoperatively (up to 3 hours)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Number of Extra Pledgets Used | 3.25 pledgets | Standard Deviation 2.82 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Number of Extra Pledgets Used | 2.63 pledgets | Standard Deviation 3.2 |
p-value: 0.126t-test, 2 sided
Secondary
Number of Nostrils With Continuous Fresh Bleeding
Number of nostrils with excessive fresh bleeding postoperatively using the 1-week postoperative bleeding questionnaire. Continuous fresh bleeding was defined as bleeding for over 15 minutes.
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| 1:1000 Epinephrine Plus Saline | Number of Nostrils With Continuous Fresh Bleeding | 7 nostrils |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Number of Nostrils With Continuous Fresh Bleeding | 5 nostrils |
p-value: 0.756t-test, 2 sided
Secondary
Postoperative Bloody Discharge Grading Score
Grading of postoperative bloody discharge postoperatively assessed by patient using the 1-week postoperative bleeding questionnaire. Scores range from 0 (no bleeding) to 5 (continuous heavy bleeding necessitating medical care).
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)
Population: Intention-to-treat analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1:1000 Epinephrine Plus Saline | Postoperative Bloody Discharge Grading Score | 2.38 score on a scale | Standard Deviation 1.14 |
| 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine | Postoperative Bloody Discharge Grading Score | 2.2 score on a scale | Standard Deviation 0.213 |
p-value: 0.213t-test, 2 sided