Analgesia, ObstetricalNCT06236126
SKIN WHEAL - Subcutaneous or Intradermal Lidocaine in Epidural for Laboring Pain.
A study testing 1% Lidocaine Injection in people with Analgesia, Obstetrical, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Obstetrical
- What is being tested?
- 1% Lidocaine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Parturient women requesting epidural analgesia for laboring pain
- Ability to consent in English language
Who cannot join
- Women undergoing cesarean delivery.
- Administration of opioids in the 4 hours before study enrollment.
- Administration of IV magnesium sulfate within the last 24 hours.
- Diabetes mellitus (Type I and II).
- Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation.
- Cervical dilation >6 cm (if in labor).
Show all 12Show fewer
- BMI ≥ 35.
- Spinal anesthesia.
- Chronic pain patients.
- Opioid use disorder
- Patient with intrauterine fetal demise
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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.
Read the 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 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.
- Conditions
- Analgesia, Obstetrical
- Being tested
- 1% Lidocaine Injection
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% Lidocaine InjectionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| INTRADERMAL | Active comparator | Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal). Receives: Procedure: 1% Lidocaine Injection |
| SUBCUTANEOUS | Active comparator | Prior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine subcutaneously (Group Subcutaneous). Receives: Procedure: 1% Lidocaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Critical-Care Pain Observation Tool (CPOT)
To assess the differences in The Critical-Care Pain Observation Tool pain scores (as units) during lidocaine administration and at epidural Tuohy needle insertion between both groups. The Critical-Care Pain Observation Tool (CPOT) includes four behavioral pain indicators (facial expressions, body movements, muscle tension and patient's vocalizations) to assess pain in critical care settings, rating pain levels with a score from 0-8.
Measured: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Secondary outcomes (4)
Numerical rating score (NRS) for pain
To assess the differences in Numerical rating score (as units) pain scores during lidocaine administration (0, no pain; 10, worst pain imaginable) at epidural Tuohy needle insertion between both groups.
Measured: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Blood pressure (BP)
To assess the differences in systolic and diastolic blood pressure (as mmHg) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups
Measured: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Heart Rate (HR)
To • To assess the differences in heart rate (as beats per minute) at baseline, lidocaine administration and epidural Tuohy needle insertion between both groups
Measured: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Patient procedural satisfaction score
To assess the differences in overall patient procedural satisfaction score (0 indicated 'total discontent' and 10 'total satisfaction') between both groups
Measured: at 30 minutes after the epidural procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start13 Nov 2023
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, ObstetricalStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Qun Hu, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236126
- Sponsor's protocol ID
- 2023H0250
- Status last verified
- Feb 2026
- First submitted
- 12 Jan 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Fifty patients will be randomized into each group before the labor epidural procedure via a web-based REDCap by an unblinded research team member. Data collection forms will be used and recorded by a blinded research team member who will keep the data and add the data into the REDCap site. Both the study subjects and the research team members who collect data will be blinded. Results will be presented as mean ± SD or median with interquartile range. Normal distribution is assessed by descriptive statistics and histograms. Data are compared between groups by using student t-test, Chi-Square, or the Mann-Whitney U test accordingly. P \< 0.05 is considered significant.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06236126
- Acronym / sponsor ID
- 2023H0250
- Conditions
- Analgesia, Obstetrical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| INTRADERMAL | Active comparator | Procedure: 1% Lidocaine InjectionPrior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine either intradermally (Group Intradermal). |
| SUBCUTANEOUS | Active comparator | Procedure: 1% Lidocaine InjectionPrior to insertion of the Tuohy epidural needle, each patient will receive an injection of 3 mL 1% lidocaine subcutaneously (Group Subcutaneous). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Parturient women requesting epidural analgesia for laboring pain
- Ability to consent in English language
Key exclusion criteria (12 listed)
- Women undergoing cesarean delivery.
- Administration of opioids in the 4 hours before study enrollment.
- Administration of IV magnesium sulfate within the last 24 hours.
- Diabetes mellitus (Type I and II).
- Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, and syncope) during IV cannulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% Lidocaine InjectionPrior 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). | Procedure or surgery | INTRADERMAL, SUBCUTANEOUS |
Primary outcome
The Critical-Care Pain Observation Tool (CPOT)
Time frame: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
To assess the differences in The Critical-Care Pain Observation Tool pain scores (as units) during lidocaine administration and at epidural Tuohy needle insertion between both groups. The Critical-Care Pain Observation Tool (CPOT) includes four behavioral pain indicators (facial expressions, body movements, muscle tension and patient's vocalizations) to assess pain in critical care settings, rating pain levels with a score from 0-8.
4 secondary outcomes
Numerical rating score (NRS) for pain
Time frame: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Blood pressure (BP)
Time frame: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Heart Rate (HR)
Time frame: at baseline, Procedure (during lidocaine administration and at epidural Tuohy needle insertion)
Patient procedural satisfaction score
Time frame: at 30 minutes after the epidural procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided. Fifty patients will be randomized into each group before the labor epidural procedure via a web-based REDCap by an unblinded research team member. Data collection forms will be used and recorded by a blinded research team member who will keep the data and add the data into the REDCap site. Both the study subjects and the research team members who collect data will be blinded. Results will be presented as mean ± SD or median with interquartile range. Normal distribution is assessed by descriptive statistics and histograms. Data are compared between groups by using student t-test, Chi-Square, or the Mann-Whitney U test accordingly. P < 0.05 is considered significant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1% Lidocaine Injection in people with Analgesia, Obstetrical, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Critical-Care Pain Observation Tool (CPOT) (time frame: Procedure (during lidocaine administration and at epidural Tuohy needle insertion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.