Use of Pre-Emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
A Randomized Controlled Trial of Use of Pre-emptive Pudendal Nerve Block for Pelvic Reconstructive Surgery
研究概览
详细说明
Subjects will have a through physical exam with evolution of the pelvis support using the POP-Q (pelvic organ prolapse quantification) system. All subjects will need to sign informed consent pre-approved by the IRB. The subjects, surgeons, and anesthesiologist will all be blinded to the injected material. The OR Scrub nurse will given the envelope at the start of each case and asked to draw the material into a syringe. All subjects will receive general anesthesia. Subjects will be randomized to receive preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine or normal saline to each side. The allocation schedule is computer generated using random-numbers table concealed in opaque envelops. Once the patient receives general anesthesia she will be positioned appropriately in dorsal lithotomy with padded Allan stir ups. 10 ml of Bupivacaine will be injected on either side using the Iowa trumpet pudendal needle drive to direct and guide appropriate position. Aspiration was attempted for every injection to decrease the chance of intravascular infusion.
At the completion of the surgery the subjects will be brought to the PACU for care. Patients are assessed immediately upon arrival to the PACU. The patients are asked their pain level using the VAS pain scale/ modified surgical pain scale at hours 1 and 2 post op. All patients are given a prescription for Vicoprofen 7.5/200mg at their pre-op visit and asked to have it filled prior to their surgery. Patients have the option to go home the same day of surgery as long as their pain is well controlled and they are clinically stable for discharge. Continued pain management and pain scale assessment will be done at 4 hours, and post op day 1 and 2. A medication log will be kept for 2 weeks post op, detailing the number of pain medications taken during that period.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10029
- Icahn School of Medicine at Mount Sinai
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- The ability to read and understand English
- Be at least 18 years old
- Symptomatic Stage 2 prolapse
Exclusion Criteria:
- Intolerance to local anesthetics or narcotics
- History of major psychiatric disorder or chronic pain syndrome
- History of substance abuse or current narcotic use
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:pudendal block
preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.
10 ml of Bupivacaine will be injected on either side using the pudendal nerve block tray.
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preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.
其他名称:
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安慰剂比较:no pudendal block
Saline
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preemptive pudendal nerve blockade with 10 ml of normal saline to each side
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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VAS pain scale
大体时间:up to 2 weeks
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up to 2 weeks
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次要结果测量
结果测量 |
大体时间 |
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post operative analgesic consumption
大体时间:up to 2 weeks
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up to 2 weeks
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adverse effect of the pudendal block
大体时间:up to 2 weeks
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up to 2 weeks
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Length of hospital stay
大体时间:up to 2 weeks
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up to 2 weeks
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Medical or surgical complications
大体时间:up to 2 weeks
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up to 2 weeks
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合作者和调查者
调查人员
- 首席研究员:Mamta Mamik, MD、Icahn School of Medicine at Mount Sinai
出版物和有用的链接
一般刊物
- Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.
- Katz J, Kavanagh BP, Sandler AN, Nierenberg H, Boylan JF, Friedlander M, Shaw BF. Preemptive analgesia. Clinical evidence of neuroplasticity contributing to postoperative pain. Anesthesiology. 1992 Sep;77(3):439-46. doi: 10.1097/00000542-199209000-00006.
- Schierup L, Schmidt JF, Torp Jensen A, Rye BA. Pudendal block in vaginal deliveries. Mepivacaine with and without epinephrine. Acta Obstet Gynecol Scand. 1988;67(3):195-7. doi: 10.3109/00016348809004200.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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pudendal block的临床试验
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Queen Mary University of LondonNational Health Service, United Kingdom未知
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University of PennsylvaniaUniversity of Wisconsin, Madison; Philips Healthcare; National Aeronautics and Space Administration...完全的