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NCT06236126 · ClinicalTrials.gov registry record · NA

SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.

A NA study, sponsored by Ohio State University.

Completed
Registry status
NA
Development phase
51
Enrollment target

NCT06236126 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 51 participants.

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The verdict

NCT06236126, a NA study, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
NA
Development phase
51 participants
Enrollment target

Study 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 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.

Interventions

  • PROCEDURE 1% Lidocaine Injection

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2023-11-13
Est. Completion 2026-01-31
Phase NA

Sponsor

Ohio State University

552 total trials

What the Registry Record Tells You About NCT06236126

The ClinicalTrials.gov registry entry for NCT06236126 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 1% Lidocaine Injection is the first listed.

NCT06236126 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06236126 about?

NCT06236126 is a clinical study titled "SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural 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 (C...

What is the current status of trial NCT06236126?

This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2023-11-13. Estimated completion is 2026-01-31.

What interventions are being tested in trial NCT06236126?

The interventions under investigation include: 1% Lidocaine Injection (PROCEDURE).

Who is sponsoring clinical trial NCT06236126?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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