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

NCT06236126 | Completed DMC

• 1 other identifier: 2023H0250
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia, Obstetrical

Outcome Measures

Primary Outcomes (1)

• The Critical-Care Pain Observation Tool (CPOT)

  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.

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

Secondary Outcomes (4)

• Numerical rating score (NRS) for pain

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

• Blood pressure (BP)

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

• Heart Rate (HR)

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

• Patient procedural satisfaction score

  at 30 minutes after the epidural procedure

Study Arms (2)

INTRADERMAL

ACTIVE COMPARATOR

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

Procedure: 1% Lidocaine Injection

SUBCUTANEOUS

ACTIVE COMPARATOR

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

Procedure: 1% Lidocaine Injection

Interventions

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).

INTRADERMAL; SUBCUTANEOUS

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A blinded observer (positioned in front of the patient and unable to see the procedure) will record data during the epidural procedure
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 1, 2024
• Study Start: November 13, 2023
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)