Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain: A Randomized Trial

Conditions

• Lidocaine Patch

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Jul 13, 2026

Start date

Jun 29, 2026

Status verified

Jul 2026

Primary completion

Jan 31, 2029

Completion

Jan 31, 2029

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Ling-Qun Hu
  6142938487
  [email protected]

Locations (1)

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