[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07700108":3,"trial-entities:NCT07700108":92,"trial-summary:NCT07700108":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":60,"minimum_age":61,"maximum_age":15,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":87,"overall_officials":89,"references":90,"see_also_links":91},"NCT07700108","2024H0309","Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain","Prospective, Single-Center, Randomized, Double-Blind Clinical Trial Evaluating Pain During Epidural Tuohy Needle Insertion After 4% Lidocaine Patch or Intradermal Lidocaine Injection in Parturient Women Requesting Epidural Analgesia","RECRUITING","2029-01-31","2026-07","2026-07-16","2026-06-29","Ohio State University","OTHER",null,"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.\n\nOne 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.\n\nPregnant 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.","Needle phobia is a significant barrier to receiving medical care and may negatively affect prenatal care, obstetric outcomes, and patient experience. During epidural placement for labor analgesia, local anesthetic is commonly administered through intradermal injection to reduce pain from Tuohy needle insertion. However, the injection itself may cause pain and increase anxiety, particularly in patients with needle phobia.\n\nTransdermal lidocaine patches provide a needle-free method of local anesthesia and have demonstrated effectiveness in reducing procedural pain in other clinical settings. This approach may decrease pain and anxiety associated with epidural placement while improving patient comfort.\n\nThis prospective, randomized, single-blinded pilot study will compare the effectiveness of a 4% lidocaine patch with standard intradermal lidocaine infiltration for reducing pain during epidural Tuohy needle insertion in laboring patients. Participants will be randomized into three groups: intradermal lidocaine alone, lidocaine patch alone, or combined lidocaine patch and intradermal lidocaine. Outcomes will include procedural pain response, vocalization and withdrawal reflex, patient-reported pain scores, hemodynamic changes, and patient satisfaction.",[19],"Needle Phobia",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},135,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":37},"DRUG","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.",[34,35,36],"Intradermal Lidocaine Injection Group","Lidocaine Patch Group","Placebo Control Group",[38],"4% Lidocaine Transdermal Patch Topical Lidocaine Patch",[40],{"measure":41,"description":42,"timeFrame":43},"Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)","The primary outcome is a composite behavioral pain response during epidural Tuohy needle insertion, defined as the presence and severity of vocalization and withdrawal reflex. This will be assessed using the Critical Care Pain Observation Tool (CPOT), which evaluates observable indicators of pain including facial expression, vocalization, body movement, and muscle tension. Higher CPOT scores indicate greater observed pain response during the procedure.","During Tuohy needle insertion (immediately at time of epidural placement procedure)",[45,49,53,57],{"measure":46,"description":47,"timeFrame":48},"Patient-Reported Pain Score During Epidural Placement (NRS)","Pain intensity reported by the participant during epidural needle insertion will be assessed using the 10-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain.","Immediately after Tuohy needle insertion during epidural placement",{"measure":50,"description":51,"timeFrame":52},"Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)","Changes in blood pressure (BP) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.","Baseline (pre-insertion) and immediately following Tuohy needle insertion",{"measure":54,"description":55,"timeFrame":56},"Patient Satisfaction With Epidural Procedure","Patient satisfaction with the epidural placement experience will be assessed using a 0-10 Likert scale, where 0 represents worst possible experience and 10 represents highest satisfaction.","At completion of epidural procedure (same visit, immediately after procedure ends)",{"measure":58,"description":59,"timeFrame":52},"Hemodynamic Response to Epidural Needle Insertion (Heart Rate)","Changes in Heart Rate (HR) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.","FEMALE","18 Years",false,{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\nAge 18 years or older Parturient women requesting neuraxial anesthesia\u002Fanalgesia (epidural or combined spinal-epidural) for vaginal or cesarean delivery Ability to provide informed consent in English\n\nExclusion Criteria:\n\nLess 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",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":84},"The Ohio State University Wexner Medical Center Hospitals","Columbus","Ohio","43201","United States",[78,83],{"name":79,"role":80,"phone":81,"email":82},"Ling-Qun Hu","CONTACT","6142938487","lingqun.hu@osumc.edu",{"name":79,"role":80},{"lat":85,"lon":86},39.96118,-82.99879,[88],{"name":79,"role":80,"phone":81,"email":82},[],[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Needle phobia",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is a randomized, single-blinded study comparing three groups: lidocaine patch alone, intradermal lidocaine alone, or both. It plans to enroll 135 participants.","completed","Lidocaine Patch vs. Intradermal Lidocaine for Epidural Pain","This study is looking at ways to reduce pain during epidural placement, especially for women who are afraid of needles (needle phobia). Researchers are comparing a 4% lidocaine patch, which is applied to the skin, with standard lidocaine injections given into the skin. The goal is to see which method is better at reducing pain when the epidural needle is inserted. You might be able to join if you are 18 or older, are pregnant, and need an epidural for delivery. The study will measure your pain response during the epidural procedure. The current status of this study is unclear, and it plans to enroll 135 participants.","Your pain response will be measured immediately during the epidural placement procedure.",107,"You would have a lidocaine patch applied to your lower back for at least 30 minutes before your epidural, or receive a standard lidocaine injection. Your pain will be measured during the epidural procedure.","Not stated in the trial record.",[],"v2"]