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RECRUITING
NCT07700108
PHASE3

Lidocaine Patch for Epidural Placement Pain in Laboring Women

Sponsor: Ohio State University

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective, Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating a 4% Lidocaine Patch for Pain During Epidural Placement in Laboring Women

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2026-10-07

Completion Date

2029-01-31

Last Updated

2026-10-23

Healthy Volunteers

No

Conditions

Interventions

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.

OTHER

Placebo Patch

Placebo patch identical in appearance to the active patch applied to the L3-L5 lumbar region approximately 30 minutes prior to epidural placement and removed immediately before epidural needle insertion.

DRUG

1% Lidocaine Skin Wheal

Subcutaneous administration of 1% lidocaine immediately before epidural needle insertion as standard clinical practice.

Locations (1)

The Ohio State University Wexner Medical Center Hospitals

Columbus, Ohio, United States