Analgesia, Obstetrical Clinical Trial
Official title:
Prospective, Single-Center, Randomized, Double-Blind, Clinical Trial for The Evaluation of Pain Associated to The Epidural Tuohy Needle Insertion With Prior Administration of Subcutaneous or Intradermal Lidocaine in Parturient Women Requesting Epidural Analgesia for Laboring Pain.
The purpose of this study is to explore the differences between the pain associated with epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal lidocaine using two different pain assessment tools (numerical rate scale (NRS) and Critical-Care Pain Observation Tool (CPOT)) in parturient women requesting epidural analgesia for laboring pain. Subjects will go through the following study procedures: review of medical history prior to surgery. Subjects will be randomly assigned to one of the two study groups in a 1:1 ratio to one of the two different standard methods to administer lidocaine prior to epidural Tuohy needle insertion: intradermal or subcutaneous lidocaine administration. Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal) or subcutaneously (Group Subcutaneous). A blinded observer (positioned in front of the patient and unable to see the procedure) will record baseline NRS scores, HR, and BP after the patient has been positioned for the epidural procedure and prior to the administration of lidocaine. During the procedure, the blinded observer will objectively record patient's vocal responses, facial expressions, bodily movements, and muscle tension (caused by pain reflex) using the CPOT and NRS scales during lidocaine administration and the first Tuohy needle insertion. After each injection, the blinded observer will record the corresponding heart rate. When the procedural anesthesiologist has exited the room, the blinded observer will then collect the patient's procedure satisfaction score from 0 (worst satisfaction) to 10 (most satisfaction) at the conclusion of the procedure. Likewise, the blinded observer will also collect the final post-procedure heart rate and blood pressure.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 13, 2026 |
Est. primary completion date | November 13, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old - Parturient women requesting epidural analgesia for laboring pain - Ability to consent in English language Exclusion Criteria: - Women undergoing cesarean delivery. - Administration of opioids in the 4 hours before study enrollment. - Administration of IV magnesium sulfate within the last 24 hours. - Diabetes mellitus (Type I and II). - Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation. - Cervical dilation >6 cm (if in labor). - BMI = 35. - Spinal anesthesia. - Chronic pain patients. - Opioid use disorder - Patient with intrauterine fetal demise - Prisoners. |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Critical-Care Pain Observation Tool (CPOT) | To assess the differences in The Critical-Care Pain Observation Tool pain scores (as units) during lidocaine administration and at epidural Tuohy needle insertion between both groups. The Critical-Care Pain Observation Tool (CPOT) includes four behavioral pain indicators (facial expressions, body movements, muscle tension and patient's vocalizations) to assess pain in critical care settings, rating pain levels with a score from 0-8. | Procedure (during lidocaine administration and at epidural Tuohy needle insertion) | |
Secondary | Numerical rating score (NRS) for pain | To assess the differences in Numerical rating score (as units) pain scores during lidocaine administration (0, no pain; 10, worst pain imaginable) at epidural Tuohy needle insertion between both groups. | Procedure (during lidocaine administration and at epidural Tuohy needle insertion) | |
Secondary | Blood pressure (BP) | To assess the differences in blood pressure (as mmHg) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups | at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion) | |
Secondary | Heart Rate (HR) | To • To assess the differences in heart rate (as beats per minute) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups | at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion) | |
Secondary | Patient procedural satisfaction score | To assess the differences in overall patient procedural satisfaction score (0 indicated 'total discontent' and 10 'total satisfaction') between both groups | at 30 minutes after the epidural procedure |
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