Characterization of the Pudendal Nerve With Transvaginal Ultrasonography
This is a feasibility study characterizing the ability of transvaginal ultrasonography to identify the pudendal nerve. Today, the pudendal nerve block is typically accomplished through blind landmark techniques, thus limiting its success. To date, there has never been an attempt to determine if the visualization of the pudendal nerve would be possible using transvaginal ultrasound with existing technology; nor to perform this procedure transvaginally with the assistance of ultrasound.
調査の概要
詳細な説明
This is a feasibility study characterizing the ability of transvaginal ultrasonography to identify the pudendal nerve. The pudendal nerve is a sensory and motor nerve arising from the sacral plexus, innervating the perineum. Anesthesia of the pudendal nerve (pudendal nerve block) is used to assist during obstetrical procedures (forceps delivery, vaginal tear repair), to improve discomfort associated with vaginal delivery when time is not sufficient to place an epidural, and to reduce pain following certain urogynecological surgeries [1-4]. Pudendal nerve block is also used to manage chronic pain associated with pudendal neuralgia [5]. Today, the pudendal nerve block is typically accomplished through blind landmark techniques, thus limiting its success [6-7]. More recently, efforts have been made to attempt this procedure with ultrasound from a more external approach transglutially, however this method requires high level of technical skill and is associated with high failure rate when compared to a blind landmark technique [8-10]. Other methods of accomplishing pudendal nerve blocks include the use of fluoroscopy. However, these renders the procedure more costly and subjects the patient to the inherent risk of radiation [11]. To date, there has never been an attempt to determine if the visualization of the pudendal nerve would be possible using transvaginal ultrasound with existing technology; nor to perform this procedure transvaginally with the assistance of ultrasound.
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Virginia
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Charlottesville、Virginia、アメリカ、22903
- University of Virginia
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Patient scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic. Or patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be included. This includes surgeries performed by surgeons in the Department of OBGYN, Division of Pelvic Medicine and Reconstructive Surgery, and includes surgeries for repair of prolapse, urinary incontinence, fistula, urethral diverticulum, or other pelvic floor issues.
説明
Inclusion Criteria:
- Scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or Gynecology clinic
- Patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be included. This includes surgeries performed by surgeons in the Department of OBGYN, Division of Pelvic Medicine and Reconstructive Surgery, and includes surgeries for repair of prolapse, urinary incontinence, fistula, urethral diverticulum, or other pelvic floor issues.
- >18 years age
- English-speaking
Exclusion Criteria:
• Refusal to participate
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
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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All subjects
Patients scheduled to have their transvaginal ultrasound for medical reasons at the fetal care center and gynecology clinic will be asked to participate in this study. Also, patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be asked to participate. |
The sonographer or study team member will scan the lateral vaginal walls (Left and right) directing the probe slightly caudad in direction of the ischial spine (IS). The IS is very echogenic and easily identifiable (bony landmark). Anatomically, the pudendal nerve courses underneath the IS and travels with the vascular bundle of the pudendal artery and pudendal vein. The artery and the vein will be identified using color flow Doppler at the time of the scan. These landmarks, IS, pudendal artery and vein will serve as the basis for the identification of the pudendal nerve. |
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 |
|---|---|---|
|
Observing the Pudendal Nerve
時間枠:day of study participate (1 day per participant)
|
We will use this study to determine if we can use transvaginal ultrasound to visualize the pudendal nerve through transvaginal ultrasound. |
day of study participate (1 day per participant)
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- KOBAK AJ, EVANS EF, JOHNSON GR. Transvaginal pudendal nerve block; a simple procedure for effective anesthesia in operative vaginal delivery. Am J Obstet Gynecol. 1956 May;71(5):981-9. No abstract available.
- Langhoff-Roos J, Lindmark G. Analgesia and maternal side effects of pudendal block at delivery. A comparison of three local anesthetics. Acta Obstet Gynecol Scand. 1985;64(3):269-72. doi: 10.3109/00016348509155127.
- Arslan M, Yazici G, Dilek U. Pudendal nerve block for pain relief in episiotomy repair. Int J Gynaecol Obstet. 2004 Nov;87(2):151-2. doi: 10.1016/j.ijgo.2004.06.020. No abstract available.
- Nikpoor P, Bain E. Analgesia for forceps delivery. Cochrane Database Syst Rev. 2013 Sep 30;9(9):CD008878. doi: 10.1002/14651858.CD008878.pub2.
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
キーワード
その他の研究ID番号
- HSR22513
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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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