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Effect of Menstrual Phase on the Anesthetic Efficacy

NCT07306533 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-12-29

No results posted yet for this study

Summary

The goal of this observational prospective clinical study is to learn whether the menstrual phase influences the anesthetic efficacy of inferior alveolar nerve block (IANB) in female patients aged 20-40 years with symptomatic irreversible pulpitis in mandibular molars. The main questions it aims to answer are:

Does the success rate of IANB vary across different phases of the menstrual cycle?

Are certain menstrual phases associated with a higher likelihood of anesthetic failure during endodontic access preparation?

Researchers will compare five menstrual phase groups (menstrual, follicular, ovulatory, luteal, and premenstrual) to see if hormonal fluctuations affect anesthetic success.

Participants will:

Receive a standardized inferior alveolar nerve block using 2% lidocaine with 1:80,000 epinephrine

Undergo cold testing and access cavity preparation to assess anesthetic success

Have intraoperative pain recorded using the Heft-Parker Visual Analog Scale (HPVAS), with menstrual phase information recorded confidentially and blinded to the treating clinician

Conditions

  • Pulpitis - Irreversible

Interventions

PROCEDURE

Inferior Alveolar Nerve Block

The patients will receive a standard inferior alveolar nerve block using 1.5 mL of 2% lidocaine with 1:80,000 epinephrine. The efficacy of anesthesia will be evaluated by two measures. First, pulpal anesthesia will be assessed using a cold test with Endo-Ice. Second, intraoperative pain will be recorded during access cavity preparation using the Heft-Parker Visual Analog Scale (HPVAS). Anesthetic outcome will be classified as either success or failure. Success will be defined as absence of response to cold testing along with no or only mild intraoperative pain (HPVAS ≤ 54 mm).

Sponsors & Collaborators

  • Jamia Millia Islamia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-11
Primary Completion
2026-03-10
Completion
2026-03-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306533 on ClinicalTrials.gov