NCT07421622

Brief Summary

The goal of this pilot randomized controlled trial is to compare pain relief efficacy while using nasal packing versus greater palatine foramen block (GPFB) in the management of acute episodes of epistaxis. The main questions it aims to answer are: Does GPFB have less potential to inflict pain when dealing with hemostasis with epistaxis, utilizing a pre-validated 10-point visual analog scale (VAS)? Was hemostasis management more effective in either technique? Researchers will compare anterior nasal packing to greater palatine foramen block using 2% xylocaine with adrenaline. Patients will receive any of the hemostatic interventions at the time of the acute epistaxis episode. The questionnaire will be administered 24 hours post-intervention.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 12, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

epistaxis

Outcome Measures

Primary Outcomes (1)

  • ● Pain intensity measured

    using the 10-point Visual Analog Scale (VAS) for the interventions mentioned

    24 hours post intervention

Secondary Outcomes (1)

  • ● Successful control of epistaxis

    24 hours post intervention

Study Arms (2)

Anterior Nasal Packing

ACTIVE COMPARATOR

Patients receiving anterior nasal packing for acture epistaxis

Procedure: Anterior Nasal Packing

Greater Palatine Foramen Block (GPFB)

ACTIVE COMPARATOR

Patients receiving GPFB to achive hemostasis in acute epistaxis

Procedure: Greater Palatine Foramen Block with 2% xylocaine with adrenaline

Interventions

Patients allocated to this group will receive a greater palatine foramen block using a local anaesthetic agent (2% i.e. 20mg/dL Inj. Lidocaine with adrenaline) administered at the greater palatine foramen under aseptic conditions. Patients will be monitored for local anaesthetic as well as GPF block-related adverse effects. Hemostasis will be assessed following the procedure.

Also known as: greater palatine foramen block, GPFB
Greater Palatine Foramen Block (GPFB)

Patients allocated to this group will receive anterior nasal packing using standard non-absorbable nasal packs following institutional protocol. Packs will remain in situ for 24-72 hours, unless earlier removal is clinically indicated.

Also known as: ANP, nasal packing, BIPP packing, merocel
Anterior Nasal Packing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presentation with active anterior epistaxis
  • Failure of initial conservative measures (e.g., nasal compression and topical vasoconstrictors)
  • Ability to provide informed consent and those who consent for the study.

You may not qualify if:

  • Suspected or confirmed posterior epistaxis
  • Known bleeding disorders or platelet count \<50,000/mm³
  • Use of anticoagulants with supratherapeutic INR
  • Known allergy to local anaesthetic agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Singh H, Sharma P, Kanotra S, Gupta K, Kotwal S, Gupta D. Role of nasal endoscopy in evaluation and management of epistaxis. International Journal of Otorhinolaryngology and Head and Neck Surgery. 2024;10(2):178-82.

    BACKGROUND
  • Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.

    PMID: 18183564BACKGROUND
  • Murray S, Mendez A, Hopkins A, El-Hakim H, Jeffery CC, Cote DWJ. Management of Persistent Epistaxis Using Floseal Hemostatic Matrix vs. traditional nasal packing: a prospective randomized control trial. J Otolaryngol Head Neck Surg. 2018 Jan 8;47(1):3. doi: 10.1186/s40463-017-0248-5.

    PMID: 29310703BACKGROUND
  • Tunkel DE, Anne S, Payne SC, Ishman SL, Rosenfeld RM, Abramson PJ, Alikhaani JD, Benoit MM, Bercovitz RS, Brown MD, Chernobilsky B, Feldstein DA, Hackell JM, Holbrook EH, Holdsworth SM, Lin KW, Lind MM, Poetker DM, Riley CA, Schneider JS, Seidman MD, Vadlamudi V, Valdez TA, Nnacheta LC, Monjur TM. Clinical Practice Guideline: Nosebleed (Epistaxis). Otolaryngol Head Neck Surg. 2020 Jan;162(1_suppl):S1-S38. doi: 10.1177/0194599819890327.

    PMID: 31910111BACKGROUND
  • Hwang SH, Kim SW, Kim SW, Kim BG, Cho JH, Kang JM. Greater palatine canal injections reduce operative bleeding during endoscopic sinus surgery: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2019 Jan;276(1):3-10. doi: 10.1007/s00405-018-5138-6. Epub 2018 Sep 20.

    PMID: 30238311BACKGROUND
  • Koskinas I, Terzis T, Georgalas C, Chatzikas G, Moireas G, Chrysovergis A, Triaridis S, Constantinidis J, Karkos P. Posterior epistaxis management: review of the literature and proposed guidelines of the hellenic rhinological-facial plastic surgery society. Eur Arch Otorhinolaryngol. 2024 Apr;281(4):1613-1627. doi: 10.1007/s00405-023-08310-4. Epub 2023 Nov 30.

    PMID: 38032485BACKGROUND
  • Corbridge RJ, Djazaeri B, Hellier WP, Hadley J. A prospective randomized controlled trial comparing the use of merocel nasal tampons and BIPP in the control of acute epistaxis. Clin Otolaryngol Allied Sci. 1995 Aug;20(4):305-7. doi: 10.1111/j.1365-2273.1995.tb00047.x.

    PMID: 8548959BACKGROUND
  • Dispenza F, Lorusso F, Di Vincenzo SA, Dolce A, Immordino A, Gallina S, Maniaci A, Lechien JR, Calvo-Henriquez C, Saibene AM, Sireci F. Management of uncontrolled/recurrent epistaxis by ligation or cauterization of the sphenopalatine artery: a scoping review. Eur Arch Otorhinolaryngol. 2024 Dec;281(12):6229-6238. doi: 10.1007/s00405-024-08852-1. Epub 2024 Jul 28.

    PMID: 39069575BACKGROUND
  • Krulewitz NA, Fix ML. Epistaxis. Emerg Med Clin North Am. 2019 Feb;37(1):29-39. doi: 10.1016/j.emc.2018.09.005.

    PMID: 30454778BACKGROUND
  • Abraham ZS, Fussi OC, Kahinga AA. Knowledge and practices of epistaxis in Eastern Tanzania: A cross-sectional study of an emergency in otorhinolaryngology. Afr J Emerg Med. 2024 Jun;14(2):70-74. doi: 10.1016/j.afjem.2024.03.002. Epub 2024 Mar 19.

    PMID: 38545448BACKGROUND

MeSH Terms

Conditions

Epistaxis

Interventions

LidocaineEpinephrineAtrial Natriuretic Factorpolyvinyl alcohol formaldehyde foam

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNatriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Sarfraz Latif, MBBS, FCPS, DLO

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor Head of Otolaryngology & Head and Neck Surgery

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share