Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain

NCT07700108 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024H0309
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Needle Phobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient-Reported Pain Score During Epidural Placement (NRS)

  Immediately after Tuohy needle insertion during epidural placement

• Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)

  Baseline (pre-insertion) and immediately following Tuohy needle insertion

• Patient Satisfaction With Epidural Procedure

  At completion of epidural procedure (same visit, immediately after procedure ends)

• Hemodynamic Response to Epidural Needle Insertion (Heart Rate)

  Baseline (pre-insertion) and immediately following Tuohy needle insertion

Study Arms (3)

Lidocaine Patch Group

EXPERIMENTAL

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%

Intradermal Lidocaine Injection Group

EXPERIMENTAL

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%

Placebo Control Group

PLACEBO COMPARATOR

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%

Interventions

Lidocaine patch 4% DRUG

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.

Also known as: 4% Lidocaine Transdermal Patch Topical Lidocaine Patch

Intradermal Lidocaine Injection Group; Lidocaine Patch Group; Placebo Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older Parturient women requesting neuraxial anesthesia/analgesia (epidural or combined spinal-epidural) for vaginal or cesarean delivery Ability to provide informed consent in English

You may not qualify if:

• Less than 30 minutes of lidocaine patch placement prior to epidural placement Administration of opioids within 4 hours before study enrollment Intravenous magnesium sulfate administration within the previous 24 hours Diabetes mellitus (Type 1 or Type 2) Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, or syncope) during intravenous cannulation Cervical dilation greater than 6 cm (if in labor) Spinal anesthesia Chronic pain condition Opioid use disorder Intrauterine fetal demise Prisoner status

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center Hospitals

Columbus, Ohio, 43201, United States

RECRUITING

Central Study Contacts

Ling-Qun Hu

CONTACT

6142938487; lingqun.hu@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment assignment. A blinded observer will collect pain scores, behavioral pain assessments, hemodynamic measurements, and satisfaction scores during the epidural procedure. The anesthesia provider performing the epidural will not be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1:1:1 ratio using the REDCap randomization system to one of three parallel treatment groups: (1) 4% lidocaine patch applied to the lower lumbar region prior to epidural placement, (2) intradermal 1% lidocaine injection prior to epidural placement, or (3) placebo/control group. Outcomes related to pain associated with epidural Tuohy needle insertion will be compared among the three groups.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 13, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

US (1)