Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain: A Randomized Trial

Prospective, Single-Center, Randomized, Double-Blind, Clinical Trial for the Evaluation of Pain Associated With the Epidural Tuohy Needle Insertion With Prior Administration of 4% Lidocaine Patch or Intradermal Lidocaine Injection in Parturient Women Requesting Epidural for Analgesia Management

Needle phobia is a barrier for receiving appropriate care during pregnancy and can lead to complications of the mother and fetus that could easily be avoided. Needle phobia can affect routine prenatal care, increase the demand for general anesthesia during c-section, and increase post-op pain. During epidural placement, providers use local anesthetic in various methods to numb the area where the needle will be inserted. Pain from these anesthetic administrations can increase needle phobia and their side effects.

One use of local anesthetic is the lidocaine patch, and studies have shown it is effective in reducing pain level in patients [6, Firmani]. The transdermal lidocaine patch may lower the physical pain and mental effects of needle phobia in pregnant women and lower the side effects from that. Although lidocaine patch may take more time to numb the skin, a high number of expecting mothers will not require an epidural for labor analgesia right away. Therefore, administration of lidocaine patch might be an effective alternative.

Pregnant women needing epidural placement will be randomized into three groups, the lidocaine patch group, intradermal anesthetic group, or use of both to determine the effectiveness of the lidocaine patch compared to the intradermal administration.

Study Overview

• Status: Recruiting
• Conditions: Lidocaine Patch
• Intervention / Treatment: Drug: Lidocaine patch 4%

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ling-Qun Hu; Phone Number: 6142938487; Email: lingqun.hu@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University Wexner Medical Center Hospitals
      • Contact: Ling-Qun Hu; Phone Number: 6142938487; Email: lingqun.hu@osumc.edu
      • Contact: Ling-Qun Hu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• o Age ³ 18 years old

  • Parturient women requesting neuraxial anesthesia/analgesia (epidural or CSE) for vaginal or Cesarean Delivery
  • Ability to consent in English

Exclusion Criteria:

• o Less than 30 minutes of lidocaine patch placement prior to epidural placement

  • Administration of opioids in the 4 hours before study enrollment
  • 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).
  • 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: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Patch Group; Participants will receive a 4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch will remain in place for a minimum of 30 minutes and then be removed immediately prior to the epidural procedure. No intradermal local anesthetic injection will be administered in this group.	Drug: Lidocaine patch 4%; 4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch remains in place for a minimum of 30 minutes and is removed immediately prior to epidural needle insertion.
Experimental: Intradermal Lidocaine Injection Group; Immediately prior to epidural placement, participants will receive a single intradermal injection of 1% lidocaine administered using a 27-gauge needle over approximately 3 seconds at the intended epidural insertion site (L3-L5). Epidural placement will proceed immediately afterward per standard clinical practice. No transdermal lidocaine patch will be used in this group.	Drug: Lidocaine patch 4%; 4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch remains in place for a minimum of 30 minutes and is removed immediately prior to epidural needle insertion.
Placebo Comparator: Placebo Control Group; Participants will receive a placebo transdermal patch applied to the L3-L5 lumbar region for at least 30 minutes prior to epidural placement, followed by a saline intradermal injection (or sham injection depending on blinding design) at the epidural insertion site using a 27-gauge needle over approximately 3 seconds. Epidural placement will then proceed per routine clinical practice.	Drug: Lidocaine patch 4%; 4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch remains in place for a minimum of 30 minutes and is removed immediately prior to epidural needle insertion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)	The primary outcome is a composite behavioral pain response during epidural Tuohy needle insertion, defined as the presence and severity of vocalization and withdrawal reflex. This will be assessed using the Critical Care Pain Observation Tool (CPOT), which evaluates observable indicators of pain including facial expression, vocalization, body movement, and muscle tension. Higher CPOT scores indicate greater observed pain response during the procedure.	During Tuohy needle insertion (immediately at time of epidural placement procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Pain Score During Epidural Placement (NRS)	Pain intensity reported by the participant during epidural needle insertion will be assessed using the 10-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain.	Immediately after Tuohy needle insertion during epidural placement
Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)	Changes in blood pressure (BP) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.	Baseline (pre-insertion) and immediately following Tuohy needle insertion
Patient Satisfaction With Epidural Procedure	Patient satisfaction with the epidural placement experience will be assessed using a 0-10 Likert scale, where 0 represents worst possible experience and 10 represents highest satisfaction.	At completion of epidural procedure (same visit, immediately after procedure ends)
Hemodynamic Response to Epidural Needle Insertion (Heart Rate)	Changes in Heart Rate (HR) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.	Baseline (pre-insertion) and immediately following Tuohy needle insertion

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024H0309

Drug and device information, study documents

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