Comparison of Paracoracoid Subscapularis Plane Block to Interscalene Block for Arthroscopic Shoulder Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
One hundred and twenty patients will be randomized to Interscalene block or Paracoracoid Subscapularis plane block. The study will evaluate the efficacy and duration of blocks in the 2 groups with regards to postoperative analgesia and degree of respiratory depression.
详细描述
Background:
Postoperative pain after arthroscopic shoulder surgery can be severe in 30- 70% of the patients in the first twenty-four to forty-eight post-operative hours . Single injection interscalene block (ISB) is commonly offered to decrease postoperative pain following shoulder surgery with many associated benefits like reduced opioid consumption, nausea and decreased Postoperative Acute Care Unit (PACU) stay. The adverse events of the ISB may be reduced with ultrasound guidance but are not completely eliminated. One of the major concerns is the phrenic nerve involvement resulting in diaphragm paresis, which has major implication in patients with respiratory compromise. One of the alternatives is blockade of the suprascapular nerve in the suprascapular fossa and the axillary nerve as it curves around the humeral neck. Although researchers from Australia have reported a good outcome with it an earlier study done by us had a suboptimal effect (102994), possibly because the nerves were blocked after the articular branches had exited the main trunk.
There are studies currently ongoing with blocks being done more proximally in our center but that requires 2 injections. The investigators did an anatomical study on Fresh frozen cadavers and noted that drugs delivered superficial to the Fascia of Subscapularis muscles stains the Axillary Nerve, Upper subscapular nerve and possibly suprascapular nerve before it enters the suprascapular fossa
The extent to which the two techniques differ in terms of overall analgesia has not been evaluated. With this background, The investigators want to compare the analgesic efficacy of interscalene block versus Paracoracoid Subscapularis plane block when combined with superficial cervical plexus block.
Aims and objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females of 16-85years of age, scheduled to undergo arthroscopic shoulder surgery.
- •Elective shoulder surgery undergoing general anesthesia in combination with regional blockade.
- •ASA Class I,II and III
- •Able to give informed consent
- •Able to cooperate with study process
- •Availability of home telephone
排除标准
- •Refusal to have regional block
- •Lack of informed consent.
- •Language or reading barrier
- •Allergy to any of the drugs used in the study.
- •Patients with associated significant cardiac and respiratory disease.
- •Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
- •Patients with coexisting hematological disorder or with deranged coagulation parameters.
- •Significant psychiatric illnesses. (Schizophrenia or bipolar disorders, uncontrolled anxiety or depression)
- •Narcotic dependency (Chronic opioid use of greater than 15 mg oral morphine equivalents daily)
- •Peripheral neuropathy
- •Emergency surgery
研究组 & 干预措施
Interscalene Block
Receives interscalene block with 15mL of ropivacaine 0.5% at the level of C6. A total of 15mL will be injected with repeated aspirations to rule out intravascular placement of the needle tip. Once this is done, the needle tip will be moved to the lateral edge of sternocleidomastoid muscle and additional 3mL of 0.5% ropivacaine will be injected between the deep fascia of the sternocleidomastoid and deep investing fascia of the neck (superficial cervical plexus block SCP).
We will administer injection of saline similar to experimental group to blind the patient
干预措施: Interscalene Block (Procedure)
Interscalene Block
Receives interscalene block with 15mL of ropivacaine 0.5% at the level of C6. A total of 15mL will be injected with repeated aspirations to rule out intravascular placement of the needle tip. Once this is done, the needle tip will be moved to the lateral edge of sternocleidomastoid muscle and additional 3mL of 0.5% ropivacaine will be injected between the deep fascia of the sternocleidomastoid and deep investing fascia of the neck (superficial cervical plexus block SCP).
We will administer injection of saline similar to experimental group to blind the patient
干预措施: Ropivacaine (Drug)
Paracoracoid SPB
Receives paracoracoid subscapularis plane block with the ultrasound. Using a 50mm 22G block needle 15ml of 0.5% Ropivacaine will be deposited anterior to the fascia of subscapularis muscle after eliciting a motor response with 0.6mA current delivered through the needle. Following this, superficial cervical plexus block will be done using 3mL of 0.5% ropivacaine similar to group 1.
干预措施: Paracoracoid SPB (Procedure)
Paracoracoid SPB
Receives paracoracoid subscapularis plane block with the ultrasound. Using a 50mm 22G block needle 15ml of 0.5% Ropivacaine will be deposited anterior to the fascia of subscapularis muscle after eliciting a motor response with 0.6mA current delivered through the needle. Following this, superficial cervical plexus block will be done using 3mL of 0.5% ropivacaine similar to group 1.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: Pain NRS measured every 120 minutes until score of 6/10 is obtained (up to 24 hours).
Duration in hours from end of injection to patient reported pain NRS score of more than 6/10
次要结局
- Measurement of diaphragm thickening pre and post block(3 measurements - pre block, 20 minutes post block & 1 hour post surgery)