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Sphenopalatine Ganglion Block Study

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status and phase

Completed
Phase 1

Conditions

Sphenopalatine Ganglion Nerve Block

Treatments

Device: angiocatheter
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05707754
2022-14616

Details and patient eligibility

About

The goal of this clinical trial is to compare the administration and dosage of bupivacaine for sphenopalatine ganglion (SPG) nerve block. The main question[s] it aims to answer are:

  • Does a high dose (3ml) give more relief than a low dose (1ml)?
  • Does bilateral administration give more relief than unilateral? Participants with headaches will be asked to lie down and have SPG block performed.

Researchers will compare dosage and administration to see how symptoms are reduced.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Present to ED for management of headache
  • Headache is moderate or severe in intensity

Exclusion criteria

  • Allergy to bupivacaine
  • Nasal or sinus surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 4 patient groups

High dose with unilateral administration
Active Comparator group
Description:
High dose (3ml) with unilateral administration of bupivacaine
Treatment:
Drug: Bupivacaine
Device: angiocatheter
High dose with bilateral administration
Active Comparator group
Description:
High dose (3ml) with bilateral administration of bupivacaine
Treatment:
Drug: Bupivacaine
Device: angiocatheter
Low dose with unilateral administration
Active Comparator group
Description:
Low dose (1ml) with unilateral administration of bupivacaine
Treatment:
Drug: Bupivacaine
Device: angiocatheter
Low dose with bilateral administration
Active Comparator group
Description:
Low dose (1ml) with bilateral administration of bupivacaine
Treatment:
Drug: Bupivacaine
Device: angiocatheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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