Comparison of Interscalene vs. Superficial Cervical Block vs. Combination of Both Blocks for Analgesia After Operative Repair of Midshaft and Lateral Clavicle Fractures
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain measurement using NRS in PACU
研究概览
简要总结
The optimal analgesic peripheral nerve block (or combinations thereof) are undefined for clavicle fractures, the most frequent fracture in the human population. This goal of this study is to determine whether interscalene block (ISB), superficial cervical plexus block (SCPB), or both provide the best analgesia for lateral and midshaft clavicular fractures, respectively.
详细描述
Clavicle fractures are relatively common injuries that occur most often in young active males and elderly individuals. They are often a result of direct trauma to the shoulder, typically from a fall. Clavicle fractures represent 5-10% of all fractures and represent the most frequent fracture in the human population. Midshaft fractures account for 69-85% of the clavicle fractures, distal shaft fractures 12-28%. (1) Analgesia for clavicle fractures can be challenging for anaesthetists secondary to the complex and varied innervation in this region. Literature describing the innervation of the clavicle and overlying skin is heterogeneous with the C3 to C6 nerve roots being involved. The clavicle itself has been reported to be innervated either by C4 or by C5 and C6 (subclavian nerve) nerve roots. (2) Regional anaesthesia for intraoperative and postoperative analgesia of clavicle fractures employs several possible, commonly used approaches. The contemporary literature surrounding the optimal regional anaesthetic technique for clavicle surgery which can provide superior postoperative analgesia and minimize systemic agents intraoperatively is lacking Currently there are only small case series or case reports published. Peripheral nerve blocks used to anesthetize the clavicle include SCPB, ISB, and combined SCPB-ISB. Larger, systematic trials have not yet been performed to our knowledge and as recently as one year ago a call for more evidence in this area of regional anaesthesia was published in the American Society of Regional Anesthesia and Pain Medicine. The purpose of this study is to compare analgesic outcomes after the common regional anesthetic techniques (ISB versus SCPB versus both).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All parties will be blinded except for the specific anesthesiologist performing the nerve blocks. This person will not be involved in providing further care (administering anesthesia) nor data collection.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing open reduction and internal fixation of clavicle fracture (midshaft or lateral)
排除标准
- •lack of patient consent
- •contra-indication to upper extremity peripheral nerve block (eg. severe pulmonary dysfunction)
- •inability to lie supine for nerve block
- •polytrauma
- •pre-existing neurologic deficit in operative upper extremity
- •allergy to amide local anesthetic
- •contralateral phrenic nerve dysfunction
- •chronic opioid use (>30mg daily oral morphine equivalent)
研究组 & 干预措施
US guided SCPB medial fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
干预措施: SCPB (Procedure)
US guided SCPB medial fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided ISB medial fracture
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: ISB (Procedure)
US guided ISB medial fracture
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided SCPB + ISB medial fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: SCPB + ISB (Procedure)
US guided SCPB + ISB medial fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided SCPB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
干预措施: SCPB (Procedure)
US guided SCPB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided SCPB + ISB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided ISB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: ISB (Procedure)
US guided ISB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5%(1:200,000) epinephrine. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: Bupivacaine hydrogen chloride , epinephrine (Drug)
US guided SCPB + ISB lateral fracture
Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine. 10ml injected for ultrasound guided Superficial Cervical Plexus Block at C4 or C5. 10ml injected for ultrasound guided Interscalene Brachial Plexus Block at C5 or C6.
干预措施: SCPB + ISB (Procedure)
结局指标
主要结局
Pain measurement using NRS in PACU
时间窗: 1 hour post-op
Numeric Rating Scale for Pain upon discharge from Post-anesthetic Care Unit
次要结局
- Opioid consumption in morphine equivalence(4 hours post-op)
- Pain measurement using NRS at Discharge(4 hours post-op)
- Satisfaction using rating scale(4 hours post-op)
研究者
Dr. Paul McHardy
Assistant Professor, Staff Anesthesiologist
Sunnybrook Health Sciences Centre