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Recruiting NCT07700108

Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain

Conditions: Needle Phobia

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 135
Sponsor: Ohio State University

Location: The Ohio State University Wexner Medical Center Hospitals Columbus Ohio

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.

Eligibility Criteria

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

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Source: ClinicalTrials.gov (NCT07700108). StuddyBuddy aggregates publicly available trial information.