NCT03970655

Brief Summary

The aim of this study is to evaluate the effect of the addition of epinephrine to bilateral real time ultrasound guided pterygopalatine ganglion blocks on intra-operative bleeding and blood loss during functional endoscopic sinus surgery (FESS).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
8mo left

Started Sep 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Sep 2019Jan 2027

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2027

Expected
Last Updated

January 27, 2026

Status Verified

April 1, 2025

Enrollment Period

6.3 years

First QC Date

May 29, 2019

Last Update Submit

January 23, 2026

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • Change in Endoscopic Grading of Nasal Bleeding

    Endoscopic Grading of Nasal Bleeding will be calculated using the 0-5 point Boezaart surgical field grading scale; 0 being no bleeding and 5 being severe bleeding.

    Every 10 minutes up to 36 hours

Study Arms (2)

Group 1

EXPERIMENTAL

a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine with epinephrine 1:200.000 with the addition of 4 milligrams of dexamethasone (1ml) and a single injection into the RIGHT pterygopalatine fossa fo 4 milliliters of 0.5% Bupivacaine or Ropivacaine without epinephrine with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side)

Drug: Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1

Group 2

EXPERIMENTAL

a single injection into the LEFT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine without epinephrine with the addition of 4 milligrams of dexamethasone (1ml) and a single injection into the RIGHT pterygopalatine fossa of 4 milliliters of 0.5% Bupivacaine or Ropivacaine with epinephrine 1:200.00 with the addition of 4 milligrams of dexamethasone (1mL) after the induction of general anesthesia. (total volume 5 ml per side).

Drug: Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2

Interventions

Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 2DRUG

Group 2 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the RIGHT pterygopalatine fossa

Group 2
Bupivacaine or Ropivacaine with epinephrine plus dexamethasone - Group 1DRUG

Group 1 will receive 4 ml of 0.5% Bupivacaine or Ropivacaine with epinephrine in the LEFT pterygopalatine fossa

Group 1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presenting for bilateral FESS
  • Adult patients (\>18 and \< 90 years old)
  • Patient consents to participate
  • No underlying chronic pain condition
  • No underlying bleeding diathesis

You may not qualify if:

  • Patient refuses to consent
  • Patient requires revision or unilateral surgery
  • Patient requires surgery in addition to FESS
  • Age younger than 18 or older than 90 years
  • Any underlying chronic pain condition
  • History of bleeding diathesis
  • Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
  • Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
  • Vulnerable patient population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Health of University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Disease

Interventions

BupivacaineRopivacaineEpinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Cameron R Smith

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

September 25, 2019

Primary Completion

January 23, 2026

Study Completion (Estimated)

January 23, 2027

Last Updated

January 27, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)