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

Analgesia, Obstetrical Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06236126
• Other study ID #: 2023H0250
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: November 13, 2026

Study information

• Verified date: January 2024
• Source: Ohio State University
• Contact: Alberto A Uribe, MD
• Phone: 6142930775
• Email: alberto.uribe[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 13, 2026
• Est. primary completion date: November 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia, Obstetrical
• Labor Pain

Intervention

Procedure:
• 1% Lidocaine Injection
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).

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical rating score (NRS) for pain	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.	Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Secondary	Blood pressure (BP)	To assess the differences in blood pressure (as mmHg) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups	at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Secondary	Heart Rate (HR)	To • To assess the differences in heart rate (as beats per minute) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups	at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Secondary	Patient procedural satisfaction score	To assess the differences in overall patient procedural satisfaction score (0 indicated 'total discontent' and 10 'total satisfaction') between both groups	at 30 minutes after the epidural procedure