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NCT Number: NCT07700108

Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain

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.

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Key information

Conditions

Needle Phobia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University Wexner Medical Center Hospitals

Columbus, Ohio, 43201, United States

Location status: Recruiting

Location contact

Ling-Qun Hu

CONTACT

[email protected]

6142938487

Ling-Qun Hu

CONTACT

About this study

Needle phobia is a significant barrier to receiving medical care and may negatively affect prenatal care, obstetric outcomes, and patient experience. During epidural placement for labor analgesia, local anesthetic is commonly administered through intradermal injection to reduce pain from Tuohy needle insertion. However, the injection itself may cause pain and increase anxiety, particularly in patients with needle phobia.

Transdermal lidocaine patches provide a needle-free method of local anesthesia and have demonstrated effectiveness in reducing procedural pain in other clinical settings. This approach may decrease pain and anxiety associated with epidural placement while improving patient comfort.

This prospective, randomized, single-blinded pilot study will compare the effectiveness of a 4% lidocaine patch with standard intradermal lidocaine infiltration for reducing pain during epidural Tuohy needle insertion in laboring patients. Participants will be randomized into three groups: intradermal lidocaine alone, lidocaine patch alone, or combined lidocaine patch and intradermal lidocaine. Outcomes will include procedural pain response, vocalization and withdrawal reflex, patient-reported pain scores, hemodynamic changes, and patient satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Other names: 4% Lidocaine Transdermal Patch Topical Lidocaine Patch

Primary outcomes

  1. Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)

    Time frame: During Tuohy needle insertion (immediately at time of epidural placement procedure)

    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.

Secondary outcomes

  1. Patient-Reported Pain Score During Epidural Placement (NRS)

    Time frame: Immediately after Tuohy needle insertion during epidural placement

    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.

  2. Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)

    Time frame: Baseline (pre-insertion) and immediately following Tuohy needle insertion

    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.

  3. Patient Satisfaction With Epidural Procedure

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

    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.

  4. Hemodynamic Response to Epidural Needle Insertion (Heart Rate)

    Time frame: Baseline (pre-insertion) and immediately following Tuohy needle insertion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ling-Qun Hu

CONTACT

[email protected]

6142938487

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Prospective, Single-Center, Randomized, Double-Blind Clinical Trial Evaluating Pain During Epidural Tuohy Needle Insertion After 4% Lidocaine Patch or Intradermal Lidocaine Injection in Parturient Women Requesting Epidural Analgesia

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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