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INTRADERMAL for Obstetric Analgesia

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The Critical-Care Pain Observation Tool (CPOT)

Secondary outcome measures

Blood pressure (BP)

Heart Rate (HR)

Numerical rating score (NRS) for pain

+1 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,570 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still eligible to enroll in this ongoing clinical trial?

"Indeed, based on the information provided by clinicaltrials.gov, this study is actively seeking individuals to participate. The trial was first posted on November 13th, 2023 and last updated on January 23rd, 2024. The research team aims to enroll a total of 50 patients from one specific location."

Answered by AI

How large is the participant pool for this clinical trial in its entirety?

"Indeed, the information provided on clinicaltrials.gov indicates that this study is actively seeking eligible participants. The trial was initially posted on November 13th, 2023 and recently updated on January 23rd, 2024. Recruitment aims to enroll a total of 50 patients at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Ling-Qun Hu 2023. "SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236126.