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RECRUITING Phase 3 ClinicalTrials.gov

Lidocaine Patch for Epidural Placement Pain in Laboring Women

Sponsor: Ohio State University • ClinicalTrials.gov ID: NCT07700108

Registry updated: 2026-10-20
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Description

Needle phobia can negatively affect the patient experience and may contribute to anxiety during labor procedures. During epidural placement, a standard intradermal lidocaine skin wheal is administered before Tuohy needle insertion; however, the injection itself may be painful. This prospective, randomized, double-blind, placebo-controlled study will evaluate whether application of a 4% lidocaine patch before epidural placement reduces procedural pain in laboring women. Participants will be randomized to receive either a 4% lidocaine patch or an identical placebo patch in addition to the standard intradermal lidocaine skin wheal. Outcomes will include pain during skin wheal administration and Tuohy needle insertion, CPOT assessments, NRS/VAS pain scores, hemodynamic responses, and patient satisfaction.

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.

Eligibility criteria

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

Conditions

Needle Phobia

Locations

  • The Ohio State University Wexner Medical Center Hospitals — Columbus, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record