Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain: A Randomized Trial
ConditionLidocaine Patch
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Lidocaine patch 4%
Drug4% 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.
Treatment groups
135 Participants
are divided into 3 treatment groupsGroup A: Lidocaine Patch GroupExperimental treatment 1 intervention
Group B: Intradermal Lidocaine Injection GroupExperimental treatment 1 intervention
Group C: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)
The primary outcome is a composite behavioral pain response during epidural Tuohy needle insertion, defined as the presence and severity of vocalization and withdrawal reflex. This will be assessed using the Critical Care Pain Observation Tool (CPOT), which evaluates observable indicators of pain including facial expression, vocalization, body movement, and muscle tension. Higher CPOT scores indicate greater observed pain response during the procedure.
Time frame
During Tuohy needle insertion (immediately at time of epidural placement procedure)Secondary outcomes
1
Patient-Reported Pain Score During Epidural Placement (NRS)
Pain intensity reported by the participant during epidural needle insertion will be assessed using the 10-point Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain.
Time frame
Immediately after Tuohy needle insertion during epidural placement2
Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)
Changes in blood pressure (BP) will be measured as physiological responses to Tuohy needle insertion. Values will be recorded immediately before and immediately after needle insertion.
Time frame
Baseline (pre-insertion) and immediately following Tuohy needle insertion3
Patient Satisfaction With Epidural Procedure
Patient satisfaction with the epidural placement experience will be assessed using a 0-10 Likert scale, where 0 represents worst possible experience and 10 represents highest satisfaction.
Time frame
At completion of epidural procedure (same visit, immediately after procedure ends)4
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.
Time frame
Baseline (pre-insertion) and immediately following Tuohy needle insertionSponsors and contacts
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Source ClinicalTrials.gov