CTRI/2024/01/061067尚未招募不适用
To study the efficacy of ultrasound guided continuous supra scapular nerve block in patients with chronic shoulder pain
JSS Academy Of Higher Education And Research1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年1月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- To study the efficacy of ultrasound guided continuous supra scapular nerve block for chronic shoulder pain regarding the intensity of pain using NRS scale
研究概览
简要总结
- Following approval from Institutional Ethical Committee, informed and written consent will be taken from 45 eligible patients who are hospitalized in JSSH for chronic shoulder pain.
- A thorough clinical evaluation with detailed shoulder examination will be performed by an experienced pain physician and Orthopedician. The diagnosis will be confirmed with USG/MRI findings of shoulder pathology concordant with the side of clinical features. The required investigations will be conducted and optimization of the comorbidities will be done before the procedure.
- 45 patients will be included in the single group and the baseline parameters will be noted. Suprascapular nerve Block (SSNB) on the affected side will be performed in the operating room under ultrasound guidance using standard ASA monitoring with ECG, HR, NIBP and SPO2.
- Under strict aseptic precautions, patient will be placed in a sitting position with hand resting on the contralateral shoulder. SSNB will be performed by posterior approach.
- High frequency linear ultrasound probe (9 -11 HZ frequency, G E machine) will be placed in coronal plane in a short axis over the spine of the scapula with slight anterior tilt. Supraspinous fossa region is identified from medial to lateral to determine the boundaries formed by spine of scapula. Ultrasound probe is adjusted in a cephalocaudal direction to visualize the trapezius, supraspinatus muscle, superior transverse scapular ligament and suprascapular notch. Doppler is used to ensure the suprascapular artery and vein in the floor of fossa.
- After local skin infiltration with an injection 1% Lidocaine, 17G Tuhoy’s needle (VYGON-FRANCE) will be inserted in the longitudinal axis of the ultrasound beam using an in-plane approach from medial to the lateral direction. Needle is advanced further until the needle tip is in the proximity of suprascapular nerve below the distal fascial layer of the supraspinatus muscle. Needle tip position will be confirmed by hydro dissection using 0.5 ml NS. After confirmation of correct needle placement 6 ml of 0.25% injection bupivacaine + 1ml (4mg ) of injection of injection dexamethasone will be instilled after negative aspiration of blood, following which 19G catheter (VYGON-FRANCE) will be inserted through tuhoy’s needle. Correct placement of Catheter tip will be confirmed by adding additional 1 ml 0.25% bupivacaine. Tuohy’s needle is removed and after the tunneling of catheter, it will be fixed to the skin above the spine of scapula using a sterile dressing.
- Immediate post- procedure patient will be assessed for pain and disability scoring and then patient will be shifted to ward with instructions to start physiotherapy.
- Suprascapular catheter will be kept in situ for the next 5 days. During the hospital stay, 6 ml of 0.25% bupivacaine will be given through the catheter intermittently at the interval of 8 hours to reduce pain and to facilitate physiotheraphy.
- Patient is subjected to physiotherapy in the form of stretching and strengthening exercises to complete the full range of motion of shoulder joint. Flexibility exercises are done to achieve the activities of daily living.
- At the end of 5 days the patient will be discharged with advice to continue the home exercise program as advised by physiotherapy post-procedure.
- Patients will be followed up immediately post - procedure and at intervals of 5 days, 2, 4, 12 and 24 weeks for assessment of pain score using NRS, pain and functional status using SPADI, patient satisfaction using Global Perceived Index, and any side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of either sex between 18 to 80 years of age with chronic shoulder pain Shoulder pain with duration of more than 3 months Pain and Restriction of range of motion in one shoulder Patients with shoulder pain NRS more than or equal to 4 patients not responding to conservative management.
排除标准
- •Patients with coagulopathy and or on anticoagulants Infection at the site of injection Hypersensitivity to local anaesthetics Malignancy as a cause of shoulder pain Evidence of significant progressive motor deficit Fractures around shoulder and clavicle.
结局指标
主要结局
To study the efficacy of ultrasound guided continuous supra scapular nerve block for chronic shoulder pain regarding the intensity of pain using NRS scale
时间窗: Pain intensity assesment will be done pre-procedure ,immediate post-procedure,and at intervals of 5 days,2,4,12 and 24 weeks .
次要结局
- To assess shoulder pain and range of motion by shouder pain and disability index (SPADI)(To determine patient satisfaction using Global perceived index (GPI))
研究者
Swathi J
JSS Academy of Higher Education and Research
研究点 (1)
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