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临床试验/CTRI/2019/04/018608
CTRI/2019/04/018608已完成4 期

A Prospective Randomized Study to compare Levobupivacaine and Ropivacaine in Patients Undergoing Forearm Orthopaedic Surgeries under Ultra Sound Guided Supraclavicular Brachial Plexus Block

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年5月5日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Study the effects of Levobupivacaine versus Ropivacaine in patients undergoing forearm orthopedic surgeries under ultra sound guided supraclavicular brachial plexus block.

研究概览

简要总结

A Prospective Randomized Study to compare Levobupivacaine and Ropivacaine in Patients Undergoing Forearm Orthopaedic Surgeries under Ultra Sound Guided Supraclavicular Brachial Plexus Block.

The patients will be randomly divided into two groups using “chit and box†method. a) Group I (L): Patient proposed to undergo upper limb surgery under Supraclavicular brachial plexus block using 30ml of 0.5% Levobupivacaine. b) Group II (R): Patients proposed to undergo upper limb surgery under Supraclavicular  brachial plexus block using 30ml of 0.5% Ropivacaine.

The patients will be placed in a supine position, with the head turned away and the ipsilateral arm adducted. Skin will be prepared with 10% povidone-iodine solution. All the patients will receive ultra sound(Sono site M-Turbo, Sono site , Inc., Bothwell , MO,USA)guided probe(frequency 10-15 MHz, covered with a sterile dressing)  to sub fascial intracluster supraclavicular brachial plexus block which was performed by  the anesthesiologist.

The needle will be removed and firm digital pressure with gauze piece will be held at the site for 5min to assist in proximal spread of the anesthetic solution.

Sensory and motor block will be evaluated preoperatively to determine a baseline and every 5 min for 30 min or until onset of blockade will be noted and thereafter every 60 min. Sensory block will be assessed by the pinprick method (22G hypodermic needle).Hemodynamic parameters and vitals (Blood pressure, Heart rate, Respiratory rate and Oxygen saturation) will be also monitored during the procedure. REFRENCES:

[1] Shantanu B, Kulkarni, Pimpare M, Balasaheb T, Govardhane. Comparison of levobupivacaine with Ropivacaine for supraclavicular brachial plexus block.Int J Res Med Sci. 2016;4:3789-96. [2] Kumar S, Palaria U, Sinha AK, Punera DC, Pandey V. Comparative evaluation of ropivacaine and ropivacaine with dexamethasone in supraclavicular brachial plexus block for postoperative analgesia. Anesth Essays Res. 2014;8:202–08.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anesthesiologists (ASA) grade I & II patients Age group 18- 60 years Patients with BMI 18.5-22.9 kg/m2 Elective cases.

排除标准

  • Infection at the end site of injection Neuromuscular disorder Patients with pre-existing diseases, cardiovascular or cerebrovascular diseases, Severely altered mental status.
  • Patient converted to general anesthesia intra-operatively.

结局指标

主要结局

Study the effects of Levobupivacaine versus Ropivacaine in patients undergoing forearm orthopedic surgeries under ultra sound guided supraclavicular brachial plexus block.

时间窗: 18 months

次要结局

  • Sensory block, Motor block , Haemodynamic parameters, and side effects.(18 months)

研究者

发起方
Department of Anaesthesiology
申办方类型
Private medical college

研究点 (1)

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