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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Ling-Qun Hu
- 電話番号：6142938487
- メール：lingqun.hu@osumc.edu
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43201
- 募集
- The Ohio State University Wexner Medical Center Hospitals
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コンタクト：
- Ling-Qun Hu
- 電話番号：6142938487
- メール：lingqun.hu@osumc.edu
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コンタクト：
- Ling-Qun Hu
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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実験的：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.
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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.
他の名前：
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プラセボコンパレーター：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Composite Behavioral Pain Response During Tuohy Needle Insertion (CPOT-Based)
時間枠：During Tuohy needle insertion (immediately at time of epidural placement procedure)
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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.
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During Tuohy needle insertion (immediately at time of epidural placement procedure)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient-Reported Pain Score During Epidural Placement (NRS)
時間枠：Immediately after Tuohy needle insertion during epidural placement
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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.
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Immediately after Tuohy needle insertion during epidural placement
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Hemodynamic Response to Epidural Needle Insertion (Blood Pressure)
時間枠：Baseline (pre-insertion) and immediately following Tuohy needle insertion
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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.
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Baseline (pre-insertion) and immediately following Tuohy needle insertion
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Patient Satisfaction With Epidural Procedure
時間枠：At completion of epidural procedure (same visit, immediately after procedure ends)
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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.
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At completion of epidural procedure (same visit, immediately after procedure ends)
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Hemodynamic Response to Epidural Needle Insertion (Heart Rate)
時間枠：Baseline (pre-insertion) and immediately following Tuohy needle insertion
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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.
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Baseline (pre-insertion) and immediately following Tuohy needle insertion
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2024H0309
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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