NCT05867342

Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

Completed Phase 4 Results posted Last updated 10 July 2023

What this trial tests

Phase 4 trial testing Epinephrin in Intraoperative Bleeding in 40 participants. Completed in 22 August 2018.

Timeline

12 May 2017

Primary endpoint
22 August 2018

22 August 2018

Quick facts

Lead sponsor	Stanford University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	12 May 2017
Primary completion	22 August 2018
Estimated completion	22 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Epinephrin — full drug profile →
• 1% lidocaine with epinephrin 1:100,000 — full drug profile →
• Saline

Conditions studied

• Intraoperative Bleeding — all drugs for Intraoperative Bleeding →

Sponsor

Stanford University

Who can join

Adults 18 to 80, any sex, with Intraoperative Bleeding. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Surgical Field Grading Score Primary · 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).

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	3.54	± 0.96
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	3.23	± 1.14

Duration of Surgery Secondary · intraoperatively (up to 3 hours)

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	72.05	± 35.74
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	54.23	± 22.27

Number of Extra Pledgets Used Secondary · intraoperatively (up to 3 hours)

A pledget is a small wad of absorbent material used to stop bleeding.

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	3.25	± 2.82
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	2.63	± 3.2

Estimated Blood Loss During Surgery Secondary · intraoperatively (up to 3 hours)

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	95.25	± 82.88
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	91.63	± 86.98

Postoperative Bloody Discharge Grading Score Secondary · 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).

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	2.38	± 1.14
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	2.2	± 0.213

Number of Days With Postoperative Bloody Nasal Discharge Secondary · 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.

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	2.85	± 2.54
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	2.73	± 2.35

Number of Nostrils With Continuous Fresh Bleeding Secondary · 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.

Group	Value	95% CI
1:1000 Epinephrine Plus Saline	7
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.