Needle Phobia
Conditions
Brief summary
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.
Detailed description
Needle phobia is a significant barrier to receiving medical care and may negatively affect prenatal care, obstetric outcomes, and patient experience. During epidural placement for labor analgesia, local anesthetic is commonly administered through intradermal injection to reduce pain from Tuohy needle insertion. However, the injection itself may cause pain and increase anxiety, particularly in patients with needle phobia. Transdermal lidocaine patches provide a needle-free method of local anesthesia and have demonstrated effectiveness in reducing procedural pain in other clinical settings. This approach may decrease pain and anxiety associated with epidural placement while improving patient comfort. This prospective, randomized, single-blinded pilot study will compare the effectiveness of a 4% lidocaine patch with standard intradermal lidocaine infiltration for reducing pain during epidural Tuohy needle insertion in laboring patients. Participants will be randomized into three groups: intradermal lidocaine alone, lidocaine patch alone, or combined lidocaine patch and intradermal lidocaine. Outcomes will include procedural pain response, vocalization and withdrawal reflex, patient-reported pain scores, hemodynamic changes, and patient satisfaction.
Interventions
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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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) 4% 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based) | During Tuohy needle insertion (immediately at time of epidural placement procedure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Pain Score During Epidural Placement (NRS) | Immediately after Tuohy needle insertion during epidural placement | 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. |
| Hemodynamic Response to Epidural Needle Insertion (Blood Pressure) | Baseline (pre-insertion) and immediately following Tuohy needle insertion | 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. |
| Patient Satisfaction With Epidural Procedure | At completion of epidural procedure (same visit, immediately after procedure ends) | 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. |
| Hemodynamic Response to Epidural Needle Insertion (Heart Rate) | Baseline (pre-insertion) and immediately following Tuohy needle insertion | 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. |
Countries
United States
Contacts
CONTACTLing-Qun Hu
Outcome results
None listed