NCT03316066撤回不适用
Comparison of Two Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for the Treatment of Complex Regional Pain Syndrome of the Arm
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain score
研究概览
简要总结
The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.
详细描述
To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of complex regional pain syndrome of the arm according to the Budapest criteria and having already received a minimum of 3 stellate ganglion blocks. Only patients having received a minimum of 3 stellate ganglion blocks will be included since it is expected to have a progressive and sustained decrease in pain scores during the first 3 blocks.
- •ASA 1 to 3 included
排除标准
- •Patient refusal
- •Contra-indications to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti platelet therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe chronic obstructive pulmonary disease, contralateral diaphragm paralysis or contralateral pneumonectomy
- •Allergy to local anesthetics
- •Concomitant pain syndrome other than complex regional pain syndrome of the arm
- •Liver or kidney failure (CrCl < 30 ml/min)
- •Inability to understand à verbal numeric pain score scale after careful explanations
- •Inability to consent
结局指标
主要结局
Pain score
时间窗: 24 hours after the stellate ganglion block
Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.
次要结局
- Pain score(14 days after the stellate ganglion block)
- Temperature increase in the ipsilateral arm(1 hour after the procedure)
- Occurrence of dysphagia after a stellate ganglion block(1 hour after the procedure)
- Occurrence of dyspnea after a stellate ganglion block(1h after the procedure)
- Horner Syndrome(1 hour after the procedure)
- Occurrence of hoarseness after a stellate ganglion block(1 hour after the procedure)
- Occurrence of foreign body sensation after a stellate ganglion block(1h after the procedure)
- Occurrence of ipsilateral arm weakness after a stellate ganglion block(1h after the procedure)
研究者
Veronique Brulotte
MD, MSc, FRCPC
Maisonneuve-Rosemont Hospital
相似试验
招募中
3 期
Comparison of the effect of Epinephrine containing Lidocaine and Mepivacaine on glycemic levelDiabetes.Diabetes mellitus due to underlying conditionIRCT20181114041651N1Shiraz University of Medical Sciences100
已完成
不适用
Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical MastectomyErector Spinae Plane BlockModified Radical MastectomyNCT06498739Cairo University52
已完成
不适用
Comparison of the Effects of Two Different Local Anesthetics Used in Spinal AnesthesiaLocal AnaesthesiaNCT06763510Ankara Ataturk Sanatorium Training and Research Hospital40
已完成
4 期
Comparison of different volumes of local anesthetic used for fascia iliaca compartment blockPost-operative painFemur disorder requiring surgeryKnee disorder requiring surgeryAnaesthesiology - Pain managementMusculoskeletal - Other muscular and skeletal disordersACTRN12616000892415metin KILINC45
已完成
不适用
The Effect of Local Anesthetic Techniques on Hemodynamic Response and Postoperative Sore Throat in Double-Lumen TubesAnesthesia, LocalIntubation, IntratrachealDouble-lumen TubeSore ThroatLidocaine SprayNCT06705595V.K.V. American Hospital, Istanbul60