Effect of Menstrual Phase on the Anesthetic Efficacy

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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

Eligibility

Primary outcome measure(s)

• Anesthetic success — From enrollment to the end of treatment at 10 months, success will be evaluated after 5 minutes of administrtion if IANB.
  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). Failure will be recorded when patients exhibit a positive cold test response and/or report moderate to severe intraoperative pain (HPVAS \> 54 mm) despite IANB administration.
• Intraoperative pain — From enrollment to the end of treatment at 10 months, success will be evaluated during the treatment.
  The intraoperative pain shall be measured using a 170mm HP visual anlouge scale.

Trial sites (1)

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