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Purpose

Needle phobia is a barrier for receiving appropriate care during pregnancy and can lead to complications of the mother and fetus that could easily be avoided. Needle phobia can affect routine prenatal care, increase the demand for general anesthesia during c-section, and increase post-op pain. During epidural placement, providers use local anesthetic in various methods to numb the area where the needle will be inserted. Pain from these anesthetic administrations can increase needle phobia and their side effects. One use of local anesthetic is the lidocaine patch, and studies have shown it is effective in reducing pain level in patients [6, Firmani]. The transdermal lidocaine patch may lower the physical pain and mental effects of needle phobia in pregnant women and lower the side effects from that. Although lidocaine patch may take more time to numb the skin, a high number of expecting mothers will not require an epidural for labor analgesia right away. Therefore, administration of lidocaine patch might be an effective alternative. Pregnant women needing epidural placement will be randomized into three groups, the lidocaine patch group, intradermal anesthetic group, or use of both to determine the effectiveness of the lidocaine patch compared to the intradermal administration.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • o Age ³ 18 years old - Parturient women requesting neuraxial anesthesia/analgesia (epidural or CSE) for vaginal or Cesarean Delivery - Ability to consent in English

Exclusion Criteria

  • o Less than 30 minutes of lidocaine patch placement prior to epidural placement - Administration of opioids in the 4 hours before study enrollment - 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). - Spinal anesthesia - Chronic pain patients - Opioid use disorder - Patient with intrauterine fetal demise - Prisoners[

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized in a 1:1:1 ratio using the REDCap randomization system to one of three parallel treatment groups: (1) 5% lidocaine patch applied to the lower lumbar region prior to epidural placement, (2) intradermal 1% lidocaine injection prior to epidural placement, or (3) placebo/control group. Outcomes related to pain associated with epidural Tuohy needle insertion will be compared among the three groups.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants and outcome assessors will be blinded to treatment assignment. A blinded observer will collect pain scores, behavioral pain assessments, hemodynamic measurements, and satisfaction scores during the epidural procedure. The anesthesia provider performing the epidural will not be blinded due to the nature of the intervention.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lidocaine Patch Group 		Participants will receive a 4% lidocaine transdermal patch applied to the L3-L5 lumbar region at least 30 minutes prior to epidural placement. The patch will remain in place for a minimum of 30 minutes and then be removed immediately prior to the epidural procedure. No intradermal local anesthetic injection will be administered in this group.
  • Drug: Lidocaine patch 4%
    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.
Experimental
Intradermal Lidocaine Injection Group 		Immediately prior to epidural placement, participants will receive a single intradermal injection of 1% lidocaine administered using a 27-gauge needle over approximately 3 seconds at the intended epidural insertion site (L3-L5). Epidural placement will proceed immediately afterward per standard clinical practice. No transdermal lidocaine patch will be used in this group.
  • Drug: Lidocaine patch 4%
    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 Comparator
Placebo Control Group 		Participants will receive a placebo transdermal patch applied to the L3-L5 lumbar region for at least 30 minutes prior to epidural placement, followed by a saline intradermal injection (or sham injection depending on blinding design) at the epidural insertion site using a 27-gauge needle over approximately 3 seconds. Epidural placement will then proceed per routine clinical practice.
  • Drug: Lidocaine patch 4%
    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.

Recruiting Locations

The Ohio State University Wexner Medical Center Hospitals
Columbus, Ohio 43201
Contact:
Ling-Qun Hu
6142938487
lingqun.hu@osumc.edu

More Details

Status
Recruiting
Sponsor
Ohio State University

Study Contact

Ling-Qun Hu
6142938487
lingqun.hu@osumc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.