A Pilot Randomized Controlled Trial in Management of Epistaxis Comparing Nasal Packing Versus Greater Palatine Foramen Block
A Pilot Randomized Controlled Trial in Management of Epistaxis Comparing Nasal Packing Versus Greater Palatine Foramen Block
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.
Introduction:
The most common otorhinolaryngological emergency in primary care and emergency departments is epistaxis, which commonly causes severe anxiety in both patients and medical professionals. It shows a bimodal age distribution, with adults between the ages of 50 and 70 and children between the ages of 2 and 10 showing a higher occurrence. Nearly 6% of the general population needs medical attention, and about 60% of people have at least one episode of epistaxis in their lives. Because of its unpredictable clinical course, epistaxis can range in intensity from moderate, self-limiting episodes to severe hemorrhage, and in some situations, it may be deemed life-threatening.
The nasal cavity is vascularized by an extensive anastomotic circuit composed of branches from both the internal and external carotid arteries. The anterior nasal septum is supplied by the anterior and posterior ethmoidal arteries, the sphenopalatine, greater palatine, and superior labial arteries. These blood vessels create Kiesselbach's plexus, which is the most common source of anterior epistaxis. The sphenopalatine artery and terminal branches of the maxillary artery, which are commonly associated with posterior epistaxis, they nourish the posterior part of nasal septum and lateral nasal wall, respectively.
Managing epistaxis has been a major problem in otolaryngology for a long time. This nasal hemorrhagic condition can be attributed to various reasons, including trauma, localized nasal pathology, hematological disorders, systemic hypertension, anticoagulant therapy, and endoscopic sinus surgery. Despite the availability of many therapy modalities, a subset of patients develops epistaxis that is resistant to standard treatment, necessitating more advanced treatment techniques.
An accepted treatment for epistaxis that has not responded to initial hemostatic methods like pressure or cautery is nasal packing. Bismuth iodoform paraffin paste (BIPP) on ribbon gauze is among the most often used packaging materials. To efficiently pack the nasal cavity with BIPP, a certain level of anatomical expertise is required while utilizing a head light, the equipments, and packing the nasal cavity. Over the last three decades, merocel nasal packs have evolved the practise and are routinely used replacing the BIPP nasal packing for controlling epistaxis that failed initial hemostasis measures. The efficacy of Merocel packs in controlling bleeding has been marked as 91.5 % in the literature. Use of the correct insertion technique is very important. Both of these techniques have equivalent effectiveness to stop bleeding and there was no significant difference in efficacy or patient tolerance of either treatment. Such nasal packing techniques have a large learning curve during insertion. Moreover, the discomfort whilst in situ and on removal is non-negotiable.
To lessen reliance on conventional nasal packing, many methods for controlling epistaxis have been investigated. These consist of topical hemostatic medicines, absorbable nasal materials, and regional anaesthetic procedures designed to induce vasoconstriction and enhance pain management.
Anatomical and clinical research have suggested that the sphenopalatine artery may contribute to recurrent anterior epistaxis. Primary feeding source for the lateral wall and majority of the septum is sphenopalatine artery. Taking a control over the vessel is thought to obtain hemostasis in epistaxis treatment and clearance in the surgical field during ESS. The block consists of administering a local anesthetic with adrenaline through the greater palatine canal (GPC).
Despite the widespread use of nasal packing, its associated complications and poor patient tolerance highlight the need for less invasive and more comfortable alternatives. Greater palatine foramen (GPF) block may provide effective hemostasis while minimizing pain and procedure-related complications. There is a lack of randomized controlled trials directly comparing nasal packing with GPF block, and no local pilot data are available to assess pain occurring to our patients in our setting. For pain assessment Visual Analogue Scale was preferred keeping the overall educational status of patients presenting to our hospital in mind.
This pilot randomized controlled trial is therefore designed to compare nasal packing versus greater palatine foramen block in the management of acute episodes of epistaxis, with the aim of generating preliminary evidence to inform the design of a larger definitive trial.
Operational definition:
Anterior Epistaxis: Epistaxis, or nosebleed, is the term used to describe a patient who has bleeding from the nostrils, nose, or nasal cavity that is severe enough to require medical attention. This covers bleeding that affects a patient's quality of life as well as bleeding that is severe, ongoing, and/or recurrent.
Haemostasis: Haemostasis will be defined as stoppage of bleeding within the first four hours after intervention without the need for additional therapy.
Methodology -
Study Design:
This study will be executed as a prospective, randomized, parallel-group pilot-controlled trial, comparing nasal packing with greater palatine foramen block in patients presenting with epistaxis. The study will be structured and reported in alignment with the SPIRIT 2025 Statement and CONSORT principles for randomized pilot trials.
Study Setting:
The research will be conducted in the Emergency Department and Otorhinolaryngology and Head & Neck Surgery Department of Shaikh Zayed Hospital Lahore. Patients with active epistaxis necessitating medical care will undergo eligibility screening.
Sample Size:
In our study, to assess effectiveness 40 patients (20 patients per group) will be recruited through consecutive; non-probability convenience, which is the sample size that is deemed appropriate for pilot studies.
Randomization, Allocation Concealment and Implementation:
Eligible participants will be assigned in a 1:1 ratio to either the nasal packing (Group A) or the greater palatine foramen block (Group B). Randomization will be carried out using basic lottery method in which equal amounts of paper chits labelled "Group A" and "Group B" will be placed in an opaque box kept in the ward cupboard not approachable to rest of the members except just one member of the project team (doctor on duty). For each enrolled participant, a chit will be picked randomly by the on-duty doctor to determine group assignment. Allocation concealment will be achieved by keeping opaque, identical chits in a confined container. The chit will be drawn only after participant enrolment and consent, prohibiting prior knowledge of treatment assignment.
Blinding:
Due to the nature of the interventions, blinding of the treating physician and participants will not be feasible. However, outcome assessment, including pain scoring and rebleeding evaluation, will be performed by an independent assessor who is blinded to group allocation and intervention whenever possible.
Attrition Bias:
Attrition is assumed to be low due to the short duration (24 hours) of treatment. Since direct mortality following either of the intervention is <0.01% i.e. highly unlikely (12), therefore anticipation for loss to follow-up due to death is negligible. Attrition may occur if failure of the allocated intervention necessitates escalation to higher-level epistaxis management, potentially leading to discontinuation of the assigned treatment. Participants will also be withdrawn from the study if they are lost to follow-up, or if they choose to withdraw consent at any stage. All withdrawals and reasons for discontinuation will be documented. Data collected up to the point of withdrawal will be included in the analysis where applicable.
Data Collection and Follow-Up:
Redcap software will be used to build the data collection tool. The residents will be responsible for the data collection. After IRB approval, the investigators will start collecting the data from patients presenting to ENT emergencies and included in the study. All the information of the patients like demographics of the patients (age, gender, residency status, comorbidities), initial hemostasis, prescriptions and type of treatments patient is entertained with; were recorded at the time of consultation. Patient pain scores will be recorded after 24 hours of the intervention via pain VAS questionnaire that would be administered either in person or by telephone. The same researcher who would not be involved in the administration of intervention of those patients, will apply all questionnaire using a pre-prepared script to avoid undue bias or coercion. The data will then be collected electronically on the redcap server database which will be maintained at the Shaikh Zayed Hospital on the structured proforma. Only the authors will have access to the final data collected. All data will be coded and anonymized for deidentification to protect the confidentiality of the subjects. Unique codes (randomly generated codes) will be given to each patient to protect confidentiality. The original subject identifiers and their assigned unique codes will only be kept in the Microsoft Excel File stored in a locked office in a password protected computer that is only available to the lead investigator.
Statistical Analysis:
All randomized participants will be analyzed according to the intention-to-treat principle, irrespective of protocol adherence or treatment compliance. This is a non-inferiority trial. A non-inferiority design was adopted because of the expected improvement in patient comfort and probable reduction in pain, making the experimental arm the preferred option if favorable outcomes in hemostasis and pain relief can be established. Data will be analyzed using SPSS version 26. The normality of the data will be checked by "Shapiro Wilk test". Continuous variables will be presented as Mean ± Standard Deviation/ median (IQR), while categorical variables will be presented as frequencies and percentages. Comparisons between groups will be performed using the "independent T-test/ Mann Whitney U test" (whilst comparison between 2 groups) or "one-way Anova/Kruskil Wallis test" (whilst comparing >2 groups) will be calculated for continuous variables. Data will be presented using charts and Bar graphs. Effect modifiers like age, gender, comorbidities, previous episodes of epistaxis, cause of epistaxis, duration since the start of epistaxis will be addressed through stratification. Chi-square or Fisher's exact test will be calculated for categorical variables. A p-value of <0.05 will be considered statistically significant throughout the study.
Inclusion Criteria:
Exclusion Criteria:
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