Recruiting
Phase 2

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 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

Study ID

NCT07700108

Start date

Jun 29, 2026

Status verified date

Jul, 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

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lidocaine Patch Group

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.

experimental: Intradermal Lidocaine Injection Group

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.

placebo comparator: Placebo Control Group

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.

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

  • Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based) [ Time Frame: During Tuohy needle insertion (immediately at time of epidural placement procedure) ]

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

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-07-16.