跳至主要内容
临床试验/CTRI/2024/05/067005
CTRI/2024/05/067005尚未招募Phase 3 4

Stellate Ganglion Block vs Interscalene Brachial Plexus Block for postoperative analgesia among patients undergoing upper limb surgeries: randomized clinical trial.

PGIMER chandigarh1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
入组人数
56
试验地点
1
主要终点
To compare the efficacy of preoperative stellate ganglion block with interscalene brachial plexus block among patients undergoing upper limb surgeries as a difference in NRS of 2.

研究概览

简要总结

Patients will be  evaluated before surgery to assess their fitness for the proposed surgical procedure under general anaesthesia, and written informed consent will be obtained at this stage. Patients will be instructed on the pain NRS scorebefore surgery, and will be  reminded before transfer to the operating theatre and in the post- anaesthesia care unit. All patients will be fasted for 8 h pre-operatively and premedicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before and 2 h before surgery. In the operating theatre, mandatory monitoring including NIBP (Non-Invasive Blood Pressure), heart rate, continuous ECG, oxygen saturation and end-tidal carbon

dioxide will be placed. Intravenous access will be established and patients receive 500 ml saline 0.9% and midazolam 1–2 mg. Stellate ganglion block (SGB group) will be  performed under ultrasound guidance using the para-tracheal, out-of-plane technique. Doppler imaging will be  used to rule out any aberrant vessels along the plane of needle placement. Three millilitres of  lignocaine 2% will be injected at the level of the C7 vertebra underneath the fascia of the longus colli muscle. Correct localisation of the injection will be  demonstrated by expansion of the fascia over the muscle. Interscalene block (IBPB group)- The block will be performed under sterile conditions. Using a high-frequency linear ultrasound transducer. The cervical roots and interscalene muscles will be  identified. The anaesthesiologist will  insert a 22 gauge. 80 mm nerve stimulating needle lateral to medial, with an in-plane technique into the interscalene groove. Once the tip of the needle was positioned in between the C5 and C6 nerve roots,  20 ml of 0.125% bupivacaine would be injected in incremental doses with intermittent aspiration Patients in both groups will be observed for any possible adverse effects of the block such as Horner’s syndrome, motor or sensory blockade of the upper limb, recurrent laryngeal nerve or phrenic nerve block  or any other effects for 10 min before induction of general anaesthesia.

General anaesthesia was induced with intravenous fentanyl 2 mcg/kg and propofol 2–3 mg/kg, and vecuronium 0.1 mg/kg will be administered to provide muscle paralysis. After tracheal intubation, anaesthesia will be maintained with nitrous oxide:oxygen 60:40 and isoflurane 1–2%, and intermittent boluses of vecuronium will be administered as required. Twenty minutes before the end of surgery, Tramadol 1 mg/kg and ondansetron 0.1 mg/kg will be administered intravenously. At the end of surgery, residual neuromuscular blockade will be reversed with intravenous neostigmine 50 mcg/kg plus glycopyrrolate 10 mcg/kg.

Routine postoperative analgesia includes intravenous paracetamol 1 g every 6 h and intra- venous diclofenac 75 mg every 12 hourly. Postoperative measurements will be  made at 0, 2, 4, 6, 8, 12,  24 and 48 hours postoperatively consisting of pain scores as measured by Numerical Rating scale (NRS) at rest and at movement. If NRS was >4, rescue analgesia in the form of  Tramadol 75 mg IV with ondansetron 4 mg will be administered. At every time point, Tramadol consumption, cardiovascular variables, sedation, nausea, vomiting, and any adverse effects like respiratory failure, hematoma will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Patients of ASA physical status 1–2, aged between 18 and 60 years with an upper limb fracture scheduled for surgery under general anaesthesia.
  • We will include patients with humerus shaft fractures, humerus surgical neck fractures and humeral supracondylar fractures, where open surgery is indicated.

排除标准

  • BMI more than 30 kg/m2, history of substance abuse, Inability to understand a pain scale (VAS, NRS), Allergy to lignocaine , Chronic sympathetic-mediated pain syndromes affecting the upper limb, Trauma other than to the affected limb, Severe congestive heart failure , Severe Chronic obstructive pulmonary disease (COPD).

结局指标

主要结局

To compare the efficacy of preoperative stellate ganglion block with interscalene brachial plexus block among patients undergoing upper limb surgeries as a difference in NRS of 2.

时间窗: 0,6,12,24 hours

次要结局

  • To determine the incidence of adverse effects in each of the two groups, To determine time to administration of first rescue analgesic, To find the total dose of tramadol consumption in first 48 hours post operatively

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Abhilash Sharma

PGIMER Chandigarh

研究点 (1)

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