Recruiting
Phase 3

Lidocaine Patch

Sponsor:

Ohio State University

Code:

NCT07700108

Conditions

Needle Phobia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lidocaine patch 4%

Study Details

Brief 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.

Conditions

Needle Phobia

Study ID

NCT07700108

Start date

Oct 7, 2026

Status verified date

Oct, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jan 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 4% Lidocaine Patch + Standard Lidocaine Wheal

Participants will receive a 4% lidocaine patch applied to the epidural insertion site for approximately 30 minutes prior to epidural placement, followed by the standard subcutaneous 1% lidocaine skin wheal administered immediately before epidural needle insertion.

placebo comparator: Placebo Patch + Standard Lidocaine Wheal

Participants will receive a placebo patch identical in appearance to the active patch applied to the epidural insertion site for approximately 30 minutes prior to epidural placement, followed by the standard subcutaneous 1% lidocaine skin wheal administered immediately before epidural needle insertion.

Interventions

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.

Primary outcome measure

  • Pain During Tuohy Needle Insertion [ Time Frame: Immediately following Tuohy needle insertion ]

Central Contacts and Locations

Central contacts

Ling-Qun Hu

6142938487lingqun.hu@osumc.edu

Locations

The Ohio State University Wexner Medical Center Hospitals

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Ling-Qun Hu

6142938487lingqun.hu@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.