The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
2017年3月24日 更新者：University of Aarhus
The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.
研究概览
详细说明
Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.
This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.
研究类型
介入性
注册 (实际的)
18
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aarhus、丹麦、8000
- Department of Anesthesiology, Aarhus University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis
- Age ≥ 18
- American Society of Anaesthesiology Classification I-III
- Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.
Exclusion Criteria:
- Communication problems or dementia
- Allergies to any medical product used in the study
- Neuropathy of the sciatic or femoral nerve prior to the operation
- Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
- Daily use of opioids
- Coagulation disorders
- Infection at the site of injection or systemic infection
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 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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实验性的：Bupivacaine-epinephrine
10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine
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50 mg bupivacaine and 50 μg adrenalin
其他名称：
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安慰剂比较：Placebo
10 ml normal saline water (sodium chloride solution, 0,9%)
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9 mg sodium chloride pr.
ml (0,9 %)
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 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)
大体时间：Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.
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Pain scores evaluated using NRS (numeric rating scale).
Significant pain is defined as NRS > 3 from the anterior and/medial side of the ankle joint.
In case of significant pain, patients receive a rescue saphenous block with 10 ml bupivacaine-adrenaline.
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Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)
大体时间：At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min.
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Test of nociceptive response in the cutaneous innervation area of the infrapatellar branch (branch of the saphenous nerve).
The test is performed in an area from the medial femoral condyle to the midline between the apex of patella and tibial tuberosity.
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At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min.
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Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)
大体时间：Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)
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Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.
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Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Thomas Fichtner Bendtsen, MD, phD、Department of Anesthesiology, Aarhus University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.
- Chen J, Lesser J, Hadzic A, Resta-Flarer F. The importance of the proximal saphenous nerve block for foot and ankle surgery. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):372. doi: 10.1097/AAP.0b013e318295596a. No abstract available.
- Clendenen SR, Whalen JL. Saphenous nerve innervation of the medial ankle. Local Reg Anesth. 2013 Mar 6;6:13-6. doi: 10.2147/LRA.S42603. Print 2013.
- Blumenthal S, Borgeat A, Neudorfer C, Bertolini R, Espinosa N, Aguirre J. Additional femoral catheter in combination with popliteal catheter for analgesia after major ankle surgery. Br J Anaesth. 2011 Mar;106(3):387-93. doi: 10.1093/bja/aeq365. Epub 2010 Dec 17.
- Kalthur SG, Sumalatha S, Nair N, Pandey AK, Sequeria S, Shobha L. Anatomic study of infrapatellar branch of saphenous nerve in male cadavers. Ir J Med Sci. 2015 Mar;184(1):201-6. doi: 10.1007/s11845-014-1087-2. Epub 2014 Feb 18.
- Kerver AL, Leliveld MS, den Hartog D, Verhofstad MH, Kleinrensink GJ. The surgical anatomy of the infrapatellar branch of the saphenous nerve in relation to incisions for anteromedial knee surgery. J Bone Joint Surg Am. 2013 Dec 4;95(23):2119-25. doi: 10.2106/JBJS.L.01297.
- Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.
- Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.
- Bjorn S, Wong WY, Baas J, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. The Importance of the Saphenous Nerve Block for Analgesia Following Major Ankle Surgery: A Randomized, Controlled, Double-Blind Study. Reg Anesth Pain Med. 2018 Jul;43(5):474-479. doi: 10.1097/AAP.0000000000000764.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月21日
初级完成 (实际的)
2017年2月28日
研究完成 (实际的)
2017年2月28日
研究注册日期
首次提交
2016年2月22日
首先提交符合 QC 标准的
2016年2月26日
首次发布 (估计)
2016年3月3日
研究记录更新
最后更新发布 (实际的)
2017年3月27日
上次提交的符合 QC 标准的更新
2017年3月24日
最后验证
2016年9月1日
更多信息
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