Comparison of combined suprascapular and axillary nerve block versus superior (upper) trunk block for phrenic nerve sparing analgesia in patients undergoing arthroscopic shoulder surgery A randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The composite primary outcome of the study will be the comparison of phrenic nerve sparing analgesia. Phrenic nerve sparing will be assessed as diaphragmatic excursion using ultrasound while the pain will be assessed both at rest and during movement using a numeric rating scale (NRS)
研究概览
简要总结
Patients undergoing shoulder arthroscopic surgeries experience intense pain in the postoperative period that interferes with recovery and rehabilitation. Peripheral nerve blocks (PNBs) are the preferred choice to provide adequate intraoperative and postoperative analgesia. Among PNBs, the interscalene approach of the brachial plexus block (ISB) is considered to be the standard and the most commonly used block for shoulder surgeries. It provides good perioperative analgesia but is inevitably known to cause hemidiaphragmatic paralysis due to ipsilateral phrenic nerve blockade which can lead to respiratory distress, especially in patients with cardio-pulmonary compromise. The superior trunk (ST) block has been described as a refinement of the conventional ISB technique where LA is injected around the ST which is formed by fusion of C5 and C6 nerve roots. ST block produces non-inferior analgesia of the shoulder compared to ISB as all the nerves innervating the shoulder arise distal to the ST. Also, the site of injection is further away from the phrenic nerve theoretically reducing the risk of hemidiaphragmatic paresis. The major nerve supply of the shoulder joint arises from the suprascapular nerve (SSN) and axillary nerve (AN). Combined blockade of these two nerves has been shown to provide equivalent analgesia to ISB in shoulder surgeries with complete elimination of the risk of hemidiaphragmatic paresis.
These two blocks i.e. ST block and combined SSN &AN block have not been compared for their phrenic nerve sparing analgesia. Therefore, we plan a study to compare these two block in terms of phrenic nerve sparing analgesia.
The enrolled patients will be randomly divided into two groups by using a computer-generated random number table and the allocation concealment will be done by a sealed opaque envelope method that will be opened just before starting premedication.
Group ‘ST’ (Superior Trunk Block)- All patients will receive ultrasound (US) guided ST block with 15 mL 0.5 percent ropivacaine.
Group ‘SSN & AN’ (combined SSN and AN block)- All patients will receive US-guided SSN and AN block with 20 mL 0.5 percent ropivacaine.
The outcome assessor/sonographer (assessing diaphragmatic excursion and NRS score) will be blinded to the group allocation.
On the day of surgery, in the preoperative area, a blinded observer will perform a US examination to determine baseline diaphragmatic excursion. The baseline pulmonary function, including forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), and the FEV1/FVC ratio will be assessed and recorded using a portable spirometer.
30 minutes after placement of the block, a repeat assessment of diaphragmatic excursion and IC will be performed and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and 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
- •Adult patients aged 18-60 years
- •Belonging to with ASA I/II/III category
- •Belonging to either sex,
- •Scheduled for unilateral shoulder orthopaedic surgery and providing consent for the procedure.
排除标准
- •Pregnant female,
- •Patient with baseline cognitive deficits sufficient to make objective pain assessment unreliable,
- •Patients with coagulopathy, liver and renal dysfunction,
- •Preoperative neurological deficits and allergy to amide local anaesthetics.
- •BMI exceeding 30 kg/m2, mental disorders, chronic obstructive pulmonary disease or any respiratory ailment, coagulation disorders, prior trauma, neuropathy, myopathy, and the need for open surgery.
结局指标
主要结局
The composite primary outcome of the study will be the comparison of phrenic nerve sparing analgesia. Phrenic nerve sparing will be assessed as diaphragmatic excursion using ultrasound while the pain will be assessed both at rest and during movement using a numeric rating scale (NRS)
时间窗: From preoperative (Baseline) to first 24 hours postoperative.
次要结局
- Comparison of time to first rescue analgesia and total analgesic consumption.(During the first 24 hours.)
- Comparison of pulmonary function (FVC, FEV1 & FEV1/FVC ratio) using portable spirometer.(At baseline and at 30 mins after the procedure)
- Comparison of procedure-related complications if any in both groups.(During first 24 hours in the postoperative period.)
研究者
Sadik Mohammed
Department of Anaesthesiology and Critical Care, AIIMS, JODHPUR
