Lidocaine Patch vs Intradermal Lidocaine for Epidural Needle Insertion Pain
Prospective, Single-Center, Randomized, Double-Blind Clinical Trial Evaluating Pain During Epidural Tuohy Needle Insertion After 4% Lidocaine Patch or Intradermal Lidocaine Injection in Parturient Women Requesting Epidural Analgesia
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Ling-Qun Hu
- Telefonnummer: 6142938487
- E-post: lingqun.hu@osumc.edu
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43201
- Rekrytering
- The Ohio State University Wexner Medical Center Hospitals
-
Kontakt:
- Ling-Qun Hu
- Telefonnummer: 6142938487
- E-post: lingqun.hu@osumc.edu
-
Kontakt:
- Ling-Qun Hu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Experimentell: 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.
|
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.
Andra namn:
|
|
Placebo-jämförare: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)
Tidsram: 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.
|
During Tuohy needle insertion (immediately at time of epidural placement procedure)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-Reported Pain Score During Epidural Placement (NRS)
Tidsram: 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.
|
Immediately after Tuohy needle insertion during epidural placement
|
|
Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)
Tidsram: 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.
|
Baseline (pre-insertion) and immediately following Tuohy needle insertion
|
|
Patient Satisfaction With Epidural Procedure
Tidsram: 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.
|
At completion of epidural procedure (same visit, immediately after procedure ends)
|
|
Hemodynamic Response to Epidural Needle Insertion (Heart Rate)
Tidsram: 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.
|
Baseline (pre-insertion) and immediately following Tuohy needle insertion
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2024H0309
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .