Comparing lidocaine methods for pain relief during epidural insertion in laboring women
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.
NA · Ohio State University · NCT06236126
This study tests which method of giving lidocaine for pain relief during epidural insertion—under the skin or in the skin—works better for women in labor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ohio State University (other) |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06236126 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in pain experienced during epidural Tuohy needle insertion when using either subcutaneous or intradermal lidocaine in parturient women seeking epidural analgesia for labor. Participants will be randomly assigned to receive either method of lidocaine administration prior to the procedure. Pain levels will be assessed using two different pain assessment tools: the numerical rating scale (NRS) and the Critical-Care Pain Observation Tool (CPOT). The study aims to gather data from 60 patients at The Ohio State University Wexner Medical Center to evaluate the effectiveness of these two approaches.
Who should consider this trial
Good fit: Ideal candidates are parturient women aged 18 and older who are requesting epidural analgesia for labor pain.
Not a fit: Patients undergoing cesarean delivery or those with certain medical conditions, such as diabetes or chronic pain, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques for women during labor.
How similar studies have performed: While this approach is novel in this specific context, similar studies have explored lidocaine administration methods, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Columbus, Ohio
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
Study contacts
- Study coordinator: Alberto A Uribe, MD
- Email: alberto.uribe@osumc.edu
- Phone: 6142930775
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Analgesia, Obstetrical