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Completed

NCT Number: NCT06236126

SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.

The purpose of this study is to explore the differences between the pain associated with epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal lidocaine using two different pain assessment tools (numerical rate scale (NRS) and Critical-Care Pain Observation Tool (CPOT)) in parturient women requesting epidural analgesia for laboring pain. Subjects will go through the following study procedures: review of medical history prior to surgery. Subjects will be randomly assigned to one of the two study groups in a 1:1 ratio to one of the two different standard methods to administer lidocaine prior to epidural Tuohy needle insertion: intradermal or subcutaneous lidocaine administration. Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal) or subcutaneously (Group Subcutaneous). A blinded observer (positioned in front of the patient and unable to see the procedure) will record baseline NRS scores, HR, and BP after the patient has been positioned for the epidural procedure and prior to the administration of lidocaine. During the procedure, the blinded observer will objectively record patient's vocal responses, facial expressions, bodily movements, and muscle tension (caused by pain reflex) using the CPOT and NRS scales during lidocaine administration and the first Tuohy needle insertion. After each injection, the blinded observer will record the corresponding heart rate. When the procedural anesthesiologist has exited the room, the blinded observer will then collect the patient's procedure satisfaction score from 0 (worst satisfaction) to 10 (most satisfaction) at the conclusion of the procedure. Likewise, the blinded observer will also collect the final post-procedure heart rate and blood pressure.

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Key information

Conditions

Analgesia, Obstetrical Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

EXPERIMENTAL METHODS Study design: A single center, prospective, randomized, double blind pilot study for the evaluation of pain due to epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal administration of lidocaine in parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division.

Sample size: Since this is a pilot study, 25 patients with complete data in each group will be needed for the study, as no single study has been found to help sample size calculations. We estimated 25 patients per group (Intradermal Group and Subcutaneous Group) will be required to learn more about procedural pain on this patient population. However, we are requesting to consent 60 subjects in total, accounting for 20% of screen failure and/or early termination. A total of 60 patients will be included.

Study Population: Parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • Parturient women requesting epidural analgesia for laboring pain
  • Ability to consent in English language

Exclusion criteria

  • Women undergoing cesarean delivery.
  • Administration of opioids in the 4 hours before study enrollment.
  • Administration of IV magnesium sulfate within the last 24 hours.
  • Diabetes mellitus (Type I and II).
  • Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation.
  • Cervical dilation >6 cm (if in labor).
  • BMI ≥ 35.
  • Spinal anesthesia.
  • Chronic pain patients.
  • Opioid use disorder
  • Patient with intrauterine fetal demise
  • Prisoners.

Treatment and study plan

1% Lidocaine Injection

Procedure

Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal) or subcutaneously (Group Subcutaneous).

Primary outcomes

  1. The Critical-Care Pain Observation Tool (CPOT)

    Time frame: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)

    To assess the differences in The Critical-Care Pain Observation Tool pain scores (as units) during lidocaine administration and at epidural Tuohy needle insertion between both groups. The Critical-Care Pain Observation Tool (CPOT) includes four behavioral pain indicators (facial expressions, body movements, muscle tension and patient's vocalizations) to assess pain in critical care settings, rating pain levels with a score from 0-8.

Secondary outcomes

  1. Numerical rating score (NRS) for pain

    Time frame: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)

    To assess the differences in Numerical rating score (as units) pain scores during lidocaine administration (0, no pain; 10, worst pain imaginable) at epidural Tuohy needle insertion between both groups.

  2. Blood pressure (BP)

    Time frame: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)

    To assess the differences in systolic and diastolic blood pressure (as mmHg) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups

  3. Heart Rate (HR)

    Time frame: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)

    To • To assess the differences in heart rate (as beats per minute) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups

  4. Patient procedural satisfaction score

    Time frame: at 30 minutes after the epidural procedure

    To assess the differences in overall patient procedural satisfaction score (0 indicated 'total discontent' and 10 'total satisfaction') between both groups

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Prospective, Single-Center, Randomized, Double-Blind, Clinical Trial for The Evaluation of Pain Associated to The Epidural Tuohy Needle Insertion With Prior Administration of Subcutaneous or Intradermal Lidocaine in Parturient Women Requesting Epidural Analgesia for Laboring Pain.

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 1, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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