Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236126
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-12
Brief Title:
SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 11 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 patients 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 patients 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
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None