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.
EXPERIMENTAL METHODS Study design: A single center, prospective, randomized, double blind pilot study for the evaluation of pain due to epidural Tuohy needle insertion with prior administration of subcutaneous or intradermal administration of lidocaine in parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division. Sample size: Since this is a pilot study, 25 patients with complete data in each group will be needed for the study, as no single study has been found to help sample size calculations. We estimated 25 patients per group (Intradermal Group and Subcutaneous Group) will be required to learn more about procedural pain on this patient population. However, we are requesting to consent 60 subjects in total, accounting for 20% of screen failure and/or early termination. A total of 60 patients will be included. Study Population: Parturient women requesting epidural analgesia for laboring pain at The Ohio State University Wexner Medical Center - Obstetric Anesthesia Division. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT02557087 -
Hyoscine ButylBromide for Intrapartum Analgesia
|
Phase 2 | |
Not yet recruiting |
NCT02578251 -
Paracetamol for Intrapartum Analgesia
|
Phase 2 | |
Completed |
NCT02509312 -
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
|
Phase 4 | |
Completed |
NCT02789410 -
Spinal Morphine vs. Hydromorphone for Pain Control After Cesarean Delivery
|
N/A | |
Completed |
NCT05099055 -
Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study
|
Phase 3 | |
Active, not recruiting |
NCT03167905 -
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
|
Phase 2/Phase 3 | |
Completed |
NCT02009722 -
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
|
Phase 4 | |
Active, not recruiting |
NCT03805607 -
IV Ketorolac on Platelet Function Post-Cesarean Delivery
|
Phase 4 | |
Completed |
NCT03574441 -
Intrapartum Epidural Catheter Displacement: Dressing Methods
|
N/A | |
Completed |
NCT02920489 -
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
|
N/A | |
Completed |
NCT02823418 -
Neuraxial Labor Analgesia and the Incidence of Postpartum Depression
|
||
Not yet recruiting |
NCT05977361 -
Intrathecal Catheter Placement Versus Resiting Epidural Catheter After Dural Puncture in Obstetric Patients
|
N/A |