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Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Study description expanded, about 164 words
    • Eligibility criteria expanded, about 3 words
    • Study title shortened, about 3 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07700108
Lead Sponsor Ohio State University
Conditions
(from sponsor)		 Needle Phobia
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov