Intraoperative BleedingPhase 4NCT05867342

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

A Phase 4 study testing Epinephrin, 1% lidocaine with epinephrin 1:100,000 and Saline in people with Intraoperative Bleeding, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intraoperative Bleeding
What is being tested?: Epinephrin, 1% lidocaine with epinephrin 1:100,000 and Saline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 12 May 2017to 22 Aug 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford
Stanford, California, 94304

Other trials in United States

About this study

Conditions: Intraoperative Bleeding
Being tested: Epinephrin, 1% lidocaine with epinephrin 1:100,000, Saline
Medical subject headings: Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EpinephrinDrug
Also called Adrenaline
Topical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity
1% lidocaine with epinephrin 1:100,000Drug
4 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)
SalineDrug
4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)

Study groups in NCT05867342
Study group	Role	What they receive
Endoscopic sinus surgery	Experimental	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, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS). Receives: Drug: Epinephrin; Drug: 1% lidocaine with epinephrin 1:100,000; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: postoperatively (approximately 20 minutes to assess)

Secondary outcomes (6)

Duration of Surgery
Measured: intraoperatively (up to 3 hours)
Number of Extra Pledgets Used
A pledget is a small wad of absorbent material used to stop bleeding.
Measured: intraoperatively (up to 3 hours)
Estimated Blood Loss During Surgery
Measured: intraoperatively (up to 3 hours)
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).
Measured: 1 week after the surgery (up to 2 minutes to complete assessment)
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.
Measured: 1 week after the surgery (up to 2 minutes to complete assessment)
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.
Measured: 1 week after the surgery (up to 2 minutes to complete assessment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 May 201722 Aug 2018

First posted22 May 2023
Study start12 May 2017
Primary completion22 Aug 2018
Study completion22 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Intraoperative BleedingStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05867342
Sponsor's protocol ID: 40274
Status last verified: Jun 2023
First submitted: 22 Nov 2018
Last updated: 10 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11.
PubMed 26452438
Yang JJ, Zheng J, Liu HJ, Liu YX, Shen JC, Zhou ZQ. Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. J Pharm Pharm Sci. 2006;9(2):190-7.
PubMed 16959188
Yang JJ, Li WY, Jil Q, Wang ZY, Sun J, Wang QP, Li ZQ, Xu JG. Local anesthesia for functional endoscopic sinus surgery employing small volumes of epinephrine-containing solutions of lidocaine produces profound hypotension. Acta Anaesthesiol Scand. 2005 Nov;49(10):1471-6. doi: 10.1111/j.1399-6576.2005.00869.x.
PubMed 16223392
Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.
PubMed 19841339
Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
PubMed 23255493
Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1275-81. doi: 10.1097/MLG.0b013e31816dd2d9.
PubMed 18438267
Tangbumrungtham N, Hwang PH, Maul X, Borchard NA, Dholakia SS, Patel ZM, Nayak JV, Choby G. The effect of topical epinephrine 1:1000 with and without infiltration of 1% lidocaine with epinephrine 1:100,000 on endoscopic surgical field visualization: a double-blind randomized controlled study. Int Forum Allergy Rhinol. 2020 Feb;10(2):147-152. doi: 10.1002/alr.22468. Epub 2019 Oct 31.
PubMed 31671251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Active, not recruitingObservational study
Safe and Timely Antithrombotic Removal (STAR) Registry
Hemorrhage, Surgical, Hemorrhage Postoperative

All Intraoperative Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
ClinicalTrials.gov ID: NCT05867342
Acronym / sponsor ID: 40274
Conditions: Intraoperative Bleeding
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 12 May 2017 (actual)
Primary completion: 22 Aug 2018 (actual)
Study completion: 22 Aug 2018 (actual)
First posted: 22 May 2023 (actual)
Results: Posted 10 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endoscopic sinus surgery	Experimental	Drug: Epinephrin, Drug: 1% lidocaine with epinephrin 1:100,000, Drug: SalineParticipants 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, during endoscopic visualization while undergoing Endoscopic sinus surgery (ESS).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EpinephrinAlso: AdrenalineTopical application of 2 pieces of Epinephrin (1:1,000)-soaked cottonoid in nasal cavity	Drug	Endoscopic sinus surgery
1% lidocaine with epinephrin 1:100,0004 ml intranasal infiltration of 1% lidocaine with epinephrine (1:100,000) at 2 sites (2 ml infiltration at each site)	Drug	Endoscopic sinus surgery
Saline4 ml intranasal infiltration of saline at 2 sites (2 ml infiltration at each site)	Drug	Endoscopic sinus surgery

Primary outcome

Surgical Field Grading Score
Time frame: 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).

6 secondary outcomes

Duration of Surgery
Time frame: intraoperatively (up to 3 hours)
Number of Extra Pledgets Used
Time frame: intraoperatively (up to 3 hours)
Estimated Blood Loss During Surgery
Time frame: intraoperatively (up to 3 hours)
Postoperative Bloody Discharge Grading Score
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)
Number of Days With Postoperative Bloody Nasal Discharge
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)
Number of Nostrils With Continuous Fresh Bleeding
Time frame: 1 week after the surgery (up to 2 minutes to complete assessment)

Results and safety

Results posted to the registry on 10 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1:1000 Epinephrine Plus Saline	40	37
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	40	37

Primary outcome: Surgical Field Grading Score

Time frame: postoperatively (approximately 20 minutes to assess). Mean (Standard Deviation). Unit: score on a scale

Measure	1:1000 Epinephrine Plus Saline n = 40	1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine n = 40
Value	3.54 (0.96)	3.23 (1.14)

1:1000 Epinephrine Plus Saline vs 1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine: p = 0.77, t-test, 2 sided

Population analysed: Intention-to-treat analysis set

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1:1000 Epinephrine Plus Saline	0 of 40 (0%)	0 of 40 (0%)	0 of 40
1:1000 Epinephrine Plus Infiltration of 1% Lidocaine With 1:100,000 Epinephrine	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26452438Saif AM, Farboud A, Delfosse E, Pope L, Adke M. Assessing the safety and efficacy of drugs used in preparing the nose for diagnostic and therapeutic procedures: a systematic review. Clin Otolaryngol. 2016 Oct;41(5):546-63. doi: 10.1111/coa.12563. Epub 2016 Feb 11.
Background: PubMed 16959188Yang JJ, Zheng J, Liu HJ, Liu YX, Shen JC, Zhou ZQ. Epinephrine infiltration on nasal field causes significant hemodynamic changes: hypotension episode monitored by impedance-cardiography under general anesthesia. J Pharm Pharm Sci. 2006;9(2):190-7.
Background: PubMed 16223392Yang JJ, Li WY, Jil Q, Wang ZY, Sun J, Wang QP, Li ZQ, Xu JG. Local anesthesia for functional endoscopic sinus surgery employing small volumes of epinephrine-containing solutions of lidocaine produces profound hypotension. Acta Anaesthesiol Scand. 2005 Nov;49(10):1471-6. doi: 10.1111/j.1399-6576.2005.00869.x.
Background: PubMed 19841339Moshaver A, Lin D, Pinto R, Witterick IJ. The hemostatic and hemodynamic effects of epinephrine during endoscopic sinus surgery: a randomized clinical trial. Arch Otolaryngol Head Neck Surg. 2009 Oct;135(10):1005-9. doi: 10.1001/archoto.2009.144.
Background: PubMed 23255493Khosla AJ, Pernas FG, Maeso PA. Meta-analysis and literature review of techniques to achieve hemostasis in endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jun;3(6):482-7. doi: 10.1002/alr.21126. Epub 2012 Dec 16.
Background: PubMed 18438267Cohen-Kerem R, Brown S, Villasenor LV, Witterick I. Epinephrine/Lidocaine injection vs. saline during endoscopic sinus surgery. Laryngoscope. 2008 Jul;118(7):1275-81. doi: 10.1097/MLG.0b013e31816dd2d9.
Results publication: PubMed 31671251Tangbumrungtham N, Hwang PH, Maul X, Borchard NA, Dholakia SS, Patel ZM, Nayak JV, Choby G. The effect of topical epinephrine 1:1000 with and without infiltration of 1% lidocaine with epinephrine 1:100,000 on endoscopic surgical field visualization: a double-blind randomized controlled study. Int Forum Allergy Rhinol. 2020 Feb;10(2):147-152. doi: 10.1002/alr.22468. Epub 2019 Oct 31.
Individual participant dataSharing planned: No

Related trials for Intraoperative Bleeding

Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Active, not recruitingObservational study
Safe and Timely Antithrombotic Removal (STAR) Registry
Hemorrhage, Surgical, Hemorrhage Postoperative

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter H Hwang, MD study director

Stanford University

Navarat Tangbumrungtham, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epinephrin, 1% lidocaine with epinephrin 1:100,000 and Saline in people with Intraoperative Bleeding, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Field Grading Score (time frame: postoperatively (approximately 20 minutes to assess)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05867342, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.