Lidocaine for Needle Phobia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a lidocaine patch can reduce the pain of receiving an epidural for women in labor. The study will compare the effectiveness of a real lidocaine patch versus a placebo in alleviating pain during the epidural needle insertion. Pregnant women planning to have an epidural for labor or delivery, who can consent in English, may qualify for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to significant research that could enhance pain management during labor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that lidocaine patches are generally safe for pain relief. Studies have found that people using a 5% lidocaine patch usually experience only mild to moderate side effects, such as minor skin irritation. This suggests that the 4% lidocaine patch used in the trial might also be well-tolerated.
Lidocaine is widely used as a numbing medicine in many medical procedures, supporting its safety. Although specific data on the 4% patch is limited, the overall evidence indicates it is safe for use.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for needle phobia, which typically involves psychological interventions or topical anesthetics like lidocaine creams, the 4% lidocaine patch offers a new delivery method. This patch is applied directly to the skin and allows lidocaine to penetrate slowly over 30 minutes, potentially providing a more even and prolonged numbing effect compared to traditional creams or injections. Researchers are excited about this treatment because it could reduce the anxiety and pain associated with needle procedures more effectively, making the experience more comfortable for patients who fear needles.
What evidence suggests that this treatment might be an effective treatment for needle phobia?
Research has shown that lidocaine patches can effectively reduce pain. One study with 94 patients demonstrated that these patches relieved pain much better than a placebo. In this trial, participants in one arm will receive a 4% lidocaine patch along with a standard lidocaine wheal to lessen both pain and anxiety for those afraid of needles. The patch delivers a numbing medicine directly to the skin, reducing discomfort. Overall, these patches offer a promising option for easing pain during medical procedures.678910
Are You a Good Fit for This Trial?
This trial is for pregnant women who need an epidural and may have a fear of needles. Participants must be able to receive local anesthetics and not have allergies or conditions that would prevent safe use of lidocaine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a 4% lidocaine patch or a placebo patch applied to the lumbar epidural insertion site for approximately 30 minutes prior to epidural placement, followed by a standard subcutaneous injection of 1% lidocaine.
Follow-up
Participants are monitored for pain during and immediately after the epidural placement procedure, including assessments of pain scores, hemodynamic responses, and patient satisfaction.
What Are the Treatments Tested in This Trial?
Interventions
- Lidocaine patch 4%
Trial Overview
The study compares three ways to numb the skin before an epidural: using a lidocaine patch, injecting lidocaine under the skin (intradermal), or both methods. Participants are randomly assigned to one group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
Citations
1.
dermatologytimes.com
dermatologytimes.com/view/novel-patch-delivers-local-anesthesia-convenience-quickness-safetyNovel patch delivers local anesthesia with convenience, ...
Ninety-four patients completed the study, and the analyses showed significant differences favoring the L/T patch over placebo in all endpoints. The only adverse ...
2.
researchgate.net
researchgate.net/publication/361714914_The_effect_of_lidocaine_patch_for_postoperative_pain_A_meta-analysis_of_randomized_controlled_trialsThe effect of lidocaine patch for postoperative pain: A meta ...
... The authors concluded that lignocaine patches can lower postoperative pain without side effects compared to placebo or no patch, but their morphine-sparing ...
3.
researchgate.net
researchgate.net/publication/8349319_Topical_Lidocaine_Patch_Therapy_for_Myofascial_Pain(PDF) Topical Lidocaine Patch Therapy for Myofascial Pain
These results suggest lidocaine patches may be useful in the management application and for 12 hours after removal of patches.
Needle phobia is keeping some people from peptides. ...
A patch of tiny needles may do what many patients fear syringes for. They can deliver vaccines, biologics, and other medicines. Transdermal ...
Lidocaine vs Menthol Patches: Which Is Right for Your Brand?
Clinical studies demonstrate that 5% lidocaine patches can reduce pain scores by 30-50% in neuropathic pain patients (Journal of Pain Research, ...
6.
dukespace.lib.duke.edu
dukespace.lib.duke.edu/bitstreams/f887dd1a-25e2-4d25-a8f3-60d026b9fbcd/downloadLidocaine patch for acute pain management - DukeSpace
The outcomes were postoperative opioid consumption, pain intensity and length of hospital stay. Results: Five trials comparing the lidocaine ...
VCU Scholars Compass - Virginia Commonwealth University
However, unlike other specific phobias, up to 56% of individuals with needle phobia also experience vasovagal syncope (i.e., a biphasic response.
Lidocaine patch 4% при Игольчатая фобия - ICH GCP
The transdermal lidocaine patch may lower the physical pain and mental effects of needle phobia in pregnant women and lower the side effects ...
9.
researchgate.net
researchgate.net/publication/340027501_The_Efficacy_Effectiveness_and_Safety_of_5_Transdermal_Lidocaine_Patch_for_Chronic_Low_Back_Pain_A_Narrative_ReviewThe Efficacy, Effectiveness and Safety of 5% Transdermal ...
... Several open-label studies have demonstrated that patients using the 5% transdermal lidocaine patch experienced statistically significant ...
10.
portalimages.blob.core.windows.net
portalimages.blob.core.windows.net/products/pdfs/ynzv3lze_NeedleCalm_-_Apr22.pdfNEEDLECALM
NeedleCalm™ is a medication-free, single-use medical device developed to alleviate pain and discomfort associated with needle-related procedures ...
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