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Lidocaine Injections for Labor Pain

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years old

Be older than 18 years old

Must not have

Women undergoing cesarean delivery

Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure (during lidocaine administration and at epidural tuohy needle insertion)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the pain experienced during the insertion of an epidural needle in women giving birth, with and without the use of lidocaine. Two different pain assessment tools will be used to

Who is the study for?

This trial is for women in labor who want epidural analgesia to manage pain. Participants must be eligible for the study based on their medical history reviewed before surgery. There are no specific inclusion or exclusion criteria provided.

What is being tested?

The study compares two ways of giving lidocaine, a numbing medication, before inserting an epidural needle: one group gets it under the skin (subcutaneous), and another just below the surface of the skin (intradermal). Pain levels will be measured using two scales by someone who can't see which method was used.

What are the potential side effects?

Possible side effects from lidocaine injections include temporary pain at injection site, redness, swelling, and rarely allergic reactions. The procedure may also cause changes in heart rate and blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having a cesarean delivery.

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I experience dizziness or fainting when getting an IV.

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I have received IV magnesium sulfate in the last 24 hours.

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I have diabetes (Type I or II).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, procedure (during lidocaine administration and at epidural tuohy needle insertion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, procedure (during lidocaine administration and at epidural tuohy needle insertion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, procedure (during lidocaine administration and at epidural tuohy needle insertion) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Critical-Care Pain Observation Tool (CPOT)

Secondary study objectives

Blood pressure (BP)

Heart Rate (HR)

Numerical rating score (NRS) for pain

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: INTRADERMALActive Control1 Intervention

Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal).

Group II: SUBCUTANEOUSActive Control1 Intervention

Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine subcutaneously (Group Subcutaneous).

0 / 5Eligibility criteria met