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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia, Obstetrical
• Intervention / Treatment: Procedure: 1% Lidocaine Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto A Uribe, MD; Phone Number: 6142930775; Email: alberto.uribe@osumc.edu
• Study Contact Backup: Name: Jeremy Reeves, BS; Phone Number: 6142933559; Email: jeremy.reeves@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Jeremy Reeves, BS; Phone Number: 6142933559; Email: jeremy.reeves@osumc.edu
      • Contact: Alberto A Uribe, MD; Phone Number: 614-293-0775; Email: alberto.uribe@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: INTRADERMAL; 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; 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).
Active Comparator: SUBCUTANEOUS; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): November 13, 2025
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2023H0250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Fifty patients will be randomized into each group before the labor epidural procedure via a web-based REDCap by an unblinded research team member. Data collection forms will be used and recorded by a blinded research team member who will keep the data and add the data into the REDCap site. Both the study subjects and the research team members who collect data will be blinded.

Results will be presented as mean ± SD or median with interquartile range. Normal distribution is assessed by descriptive statistics and histograms. Data are compared between groups by using student t-test, Chi-Square, or the Mann-Whitney U test accordingly. P < 0.05 is considered significant.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No