Needle PhobiaPhase 3NCT07700108
Lidocaine Patch for Epidural Placement Pain in Laboring Women
A Phase 3 study testing Lidocaine patch 4% and 1% Lidocaine Skin Wheal in people with Needle Phobia, run by Ohio State University at 1 site in United States.
Trial summary
Needle phobia can negatively affect the patient experience and may contribute to anxiety during labor procedures. During epidural placement, a standard intradermal lidocaine skin wheal is administered before Tuohy needle insertion; however, the injection itself may be painful. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Needle Phobia
- What is being tested?
- Lidocaine patch 4% and 1% Lidocaine Skin Wheal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2026to 31 Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older Parturient women requesting neuraxial anesthesia/analgesia (epidural or combined spinal-epidural) for vaginal or cesarean delivery Ability to provide informed consent in English
Who cannot join
- Less than 30 minutes of lidocaine patch placement prior to epidural placement Administration of opioids within 4 hours before study enrollment Intravenous magnesium sulfate administration within the previous 24 hours Diabetes mellitus (Type 1 or Type 2) Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, or syncope) during intravenous cannulation Cervical dilation greater than 6 cm (if in labor) Spinal anesthesia Chronic pain condition Opioid use disorder Intrauterine fetal demise Prisoner status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center Hospitals
Columbus, Ohio, 43201
Ling-Qun Hu, 6142938487, lingqun.hu@osumc.edu
Ling-Qun Hu
About this study
Official title: Prospective, Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating a 4% Lidocaine Patch for Pain During Epidural Placement in Laboring Women
Needle phobia can negatively affect the patient experience and may contribute to anxiety during labor procedures. During epidural placement, a standard intradermal lidocaine skin wheal is administered before Tuohy needle insertion; however, the injection itself may be painful.
This prospective, randomized, double-blind, placebo-controlled study will evaluate whether application of a 4% lidocaine patch before epidural placement reduces procedural pain in laboring women. Participants will be randomized to receive either a 4% lidocaine patch or an identical placebo patch in addition to the standard intradermal lidocaine skin wheal. Outcomes will include pain during skin wheal administration and Tuohy needle insertion, CPOT assessments, NRS/VAS pain scores, hemodynamic responses, and patient satisfaction.
Read the detailed description
Needle phobia is a recognized barrier to receiving medical care and may negatively affect the prenatal, intrapartum, and postoperative experiences of pregnant patients. During epidural placement for labor analgesia, a local anesthetic skin wheal is routinely administered prior to Tuohy needle insertion to reduce procedural pain. However, the injection itself may be uncomfortable and may contribute to patient anxiety.
Transdermal lidocaine patches provide a noninvasive method of local anesthesia and have demonstrated effectiveness in reducing procedural pain in various clinical settings. Application of a 4% lidocaine patch before epidural placement may provide additional analgesia, decrease discomfort associated with epidural placement, and improve the overall patient experience.
This prospective, single-center, randomized, double-blind, placebo-controlled trial will evaluate the effectiveness of a 4% lidocaine patch applied before epidural placement in laboring women. Participants will be randomized in a 1:1 ratio to receive either a 4% lidocaine patch or an identical placebo patch applied to the epidural insertion site prior to the procedure. All participants will receive the standard intradermal 1% lidocaine skin wheal immediately before epidural needle insertion.
The primary objective is to determine whether the addition of a 4% lidocaine patch reduces pain during epidural placement compared with placebo. Study outcomes will include pain during skin wheal administration and Tuohy needle insertion, CPOT assessments, patient-reported NRS and VAS pain scores, hemodynamic responses during the procedure, and patient satisfaction with the epidural placement experience. The results of this pilot study will help determine whether transdermal lidocaine patches may serve as a useful adjunct to standard local anesthetic techniques for labor epidural placement.
- Conditions
- Needle Phobia
- Being tested
- Lidocaine patch 4%, Placebo Patch, 1% Lidocaine Skin Wheal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine patch 4%Drug
Also called 4% Lidocaine Transdermal Patch Topical Lidocaine Patch
4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch remains in place for a minimum of 30 minutes and is removed immediately prior to epidural needle insertion.
Placebo PatchOther
Placebo patch identical in appearance to the active patch applied to the L3-L5 lumbar region approximately 30 minutes prior to epidural placement and removed immediately before epidural needle insertion.
1% Lidocaine Skin WhealDrug
Subcutaneous administration of 1% lidocaine immediately before epidural needle insertion as standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 4% Lidocaine Patch + Standard Lidocaine Wheal | Experimental | Participants will receive a 4% lidocaine transdermal patch applied to the lumbar epidural insertion site (L3-L5 region) for approximately 30 minutes prior to epidural placement. Following patch removal, a standard subcutaneous injection of 1% lidocaine will be administered immediately before epidural needle insertion. Receives: Drug: Lidocaine patch 4%; Drug: 1% Lidocaine Skin Wheal |
| Placebo Patch + Standard Lidocaine Wheal | Placebo comparator | Participants will receive a placebo patch identical in appearance to the active patch applied to the epidural insertion site for approximately 30 minutes prior to epidural placement, followed by the standard subcutaneous 1% lidocaine skin wheal administered immediately before epidural needle insertion. Receives: Other: Placebo Patch; Drug: 1% Lidocaine Skin Wheal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Tuohy Needle Insertion
Pain during epidural needle (Tuohy needle) insertion measured using the Numeric Rating Scale (NRS), a self-reported pain scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Immediately following Tuohy needle insertion
Secondary outcomes (5)
Pain During Skin Wheal Administration
Pain associated with administration of the standard 1% lidocaine skin wheal measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity.
Measured: Immediately after skin wheal administration
Critical-Care Pain Observation Tool (CPOT) Score
Observed pain behaviors assessed using the Critical-Care Pain Observation Tool (CPOT). Scores range from 0 to 8, with higher scores indicating greater observed pain.
Measured: During epidural placement procedure
Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) Pain Scores
Numeric Rating Scale (NRS): 0-10, where 0 = no pain and 10 = worst imaginable pain; higher scores indicate greater pain severity.
Visual Analog Scale (VAS): 0-100 mm, where 0 = no pain and 100 = worst imaginable pain; higher scores indicate greater pain severity.
Measured: Immediately following epidural placement
Hemodynamic Response to Epidural Needle Insertion (Heart Rate)
Changes in Heart Rate (HR) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.
Measured: Baseline (pre-insertion) and immediately following Tuohy needle insertion
Patient Satisfaction With Epidural Placement Experience
Participant-reported satisfaction with the epidural placement procedure measured using a 0-10 satisfaction scale, where 0 = completely dissatisfied and 10 = completely satisfied. Higher scores indicate greater satisfaction.
Measured: Within 30 minutes after epidural placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start7 Oct 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle PhobiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The control group will receive a placebo patch plus standard 1% lidocaine skin wheal prior to epidural placement, while the intervention group will receive a 4% lidocaine patch plus standard 1% lidocaine skin wheal. Outcomes will be compared between groups during epidural placement.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
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
- NCT07700108
- Sponsor's protocol ID
- 2024H0309
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Center, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating a 4% Lidocaine Patch for Pain During Epidural Placement in Laboring Women
- ClinicalTrials.gov ID
- NCT07700108
- Acronym / sponsor ID
- 2024H0309
- Conditions
- Needle Phobia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 7 Oct 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 13 Jul 2026 (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.
Needle phobia can negatively affect the patient experience and may contribute to anxiety during labor procedures. During epidural placement, a standard intradermal lidocaine skin wheal is administered before Tuohy needle insertion; however, the injection itself may be painful.
This prospective, randomized, double-blind, placebo-controlled study will evaluate whether application of a 4% lidocaine patch before epidural placement reduces procedural pain in laboring women. Participants will be randomized to receive either a 4% lidocaine patch or an identical placebo patch in addition to the standard intradermal lidocaine skin wheal. Outcomes will include pain during skin wheal administration and Tuohy needle insertion, CPOT assessments, NRS/VAS pain scores, hemodynamic responses, and patient satisfaction.
Detailed description
Needle phobia is a recognized barrier to receiving medical care and may negatively affect the prenatal, intrapartum, and postoperative experiences of pregnant patients. During epidural placement for labor analgesia, a local anesthetic skin wheal is routinely administered prior to Tuohy needle insertion to reduce procedural pain. However, the injection itself may be uncomfortable and may contribute to patient anxiety.
Transdermal lidocaine patches provide a noninvasive method of local anesthesia and have demonstrated effectiveness in reducing procedural pain in various clinical settings. Application of a 4% lidocaine patch before epidural placement may provide additional analgesia, decrease discomfort associated with epidural placement, and improve the overall patient experience.
This prospective, single-center, randomized, double-blind, placebo-controlled trial will evaluate the effectiveness of a 4% lidocaine patch applied before epidural placement in laboring women. Participants will be randomized in a 1:1 ratio to receive either a 4% lidocaine patch or an identical placebo patch applied to the epidural insertion site prior to the procedure. All participants will receive the standard intradermal 1% lidocaine skin wheal immediately before epidural needle insertion.
The primary objective is to determine whether the addition of a 4% lidocaine patch reduces pain during epidural placement compared with placebo. Study outcomes will include pain during skin wheal administration and Tuohy needle insertion, CPOT assessments, patient-reported NRS and VAS pain scores, hemodynamic responses during the procedure, and patient satisfaction with the epidural placement experience. The results of this pilot study will help determine whether transdermal lidocaine patches may serve as a useful adjunct to standard local anesthetic techniques for labor epidural placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel groups. The control group will receive a placebo patch plus standard 1% lidocaine skin wheal prior to epidural placement, while the intervention group will receive a 4% lidocaine patch plus standard 1% lidocaine skin wheal. Outcomes will be compared between groups during epidural placement.
| Arm | Type | Receives |
|---|---|---|
| 4% Lidocaine Patch + Standard Lidocaine Wheal | Experimental | Drug: Lidocaine patch 4%, Drug: 1% Lidocaine Skin WhealParticipants will receive a 4% lidocaine transdermal patch applied to the lumbar epidural insertion site (L3-L5 region) for approximately 30 minutes prior to epidural placement. Following patch removal, a standard subcutaneous injection of 1% lidocaine will be administered immediately before epidural needle insertion. |
| Placebo Patch + Standard Lidocaine Wheal | Placebo comparator | Other: Placebo Patch, Drug: 1% Lidocaine Skin WhealParticipants will receive a placebo patch identical in appearance to the active patch applied to the epidural insertion site for approximately 30 minutes prior to epidural placement, followed by the standard subcutaneous 1% lidocaine skin wheal administered immediately before epidural needle insertion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or older Parturient women requesting neuraxial anesthesia/analgesia (epidural or combined spinal-epidural) for vaginal or cesarean delivery Ability to provide informed consent in English
Key exclusion criteria (1 listed)
- Less than 30 minutes of lidocaine patch placement prior to epidural placement Administration of opioids within 4 hours before study enrollment Intravenous magnesium sulfate administration within the previous 24 hours Diabetes mellitus (Type 1 or Type 2) Neurocardiogenic signs or symptoms (e.g., dizziness, lightheadedness, bradycardia, or syncope) during intravenous cannulation Cervical dilation greater than 6 cm (if in labor) Spinal anesthesia Chronic pain condition Opioid use disorder Intrauterine fetal demise Prisoner status
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 |
|---|---|---|
| Lidocaine patch 4%Also: 4% Lidocaine Transdermal Patch Topical Lidocaine Patch4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch remains in place for a minimum of 30 minutes and is removed immediately prior to epidural needle insertion. | Drug | 4% Lidocaine Patch + Standard Lidocaine Wheal |
| Placebo PatchPlacebo patch identical in appearance to the active patch applied to the L3-L5 lumbar region approximately 30 minutes prior to epidural placement and removed immediately before epidural needle insertion. | Other | Placebo Patch + Standard Lidocaine Wheal |
| 1% Lidocaine Skin WhealSubcutaneous administration of 1% lidocaine immediately before epidural needle insertion as standard clinical practice. | Drug | 4% Lidocaine Patch + Standard Lidocaine Wheal, Placebo Patch + Standard Lidocaine Wheal |
Primary outcome
Pain During Tuohy Needle Insertion
Time frame: Immediately following Tuohy needle insertion
Pain during epidural needle (Tuohy needle) insertion measured using the Numeric Rating Scale (NRS), a self-reported pain scale ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate greater pain severity.
5 secondary outcomes
Pain During Skin Wheal Administration
Time frame: Immediately after skin wheal administration
Critical-Care Pain Observation Tool (CPOT) Score
Time frame: During epidural placement procedure
Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) Pain Scores
Time frame: Immediately following epidural placement
Hemodynamic Response to Epidural Needle Insertion (Heart Rate)
Time frame: Baseline (pre-insertion) and immediately following Tuohy needle insertion
Patient Satisfaction With Epidural Placement Experience
Time frame: Within 30 minutes after epidural placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine patch 4% and 1% Lidocaine Skin Wheal in people with Needle Phobia, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling-Qun Hu (6142938487, lingqun.hu@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Tuohy Needle Insertion (time frame: Immediately following 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 23 Oct 2026.