Early Versus Late Deflation of Distal Tourniquet in Intravenous Regional Anesthesia With and Without Ketorolac in Hand & Forearm Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Efficiency of intravenous regional anesthesia assessed by visual analogue scale
研究概览
简要总结
Bier block , or intravenous regional anesthesia (IVRA), is a method of anesthesia for upper extremity surgeries. IVRA was first described by August Bier in 1908, and after a period of latency, it began to gain widespread use after Holmes reemphasized its use in 1963. Bier blocks are technically easy to perform, and the rates for successful anesthesia approach 98%. Furthermore, when compared with brachial plexus blocks for outpatient hand and upper extremity surgery, IVRA may realize lower costs and faster postanesthesia recovery.
Although a reliable source of anesthesia, IVRA has been associated with some disadvantages. Some patients cannot tolerate the tourniquet-mediated arm pain, and there are also reports of neurologic injury and compartment syndrome caused by the tourniquet. Perhaps the most serious complications associated with IVRA relate to the potential systemic toxicity of the local anesthetics used. If the local anesthetic gains access to a patient's systemic circulation, the central nervous system (CNS) and cardiovascular system can be affected. The CNS is usually affected first, with symptoms including dizziness, tinnitus, perioral paresthesia, and seizures. Anesthetic-induced toxicity of the cardiovascular system may manifest as hypotension, bradycardia, arrhythmias, or cardiac arrest.
Historically, the tourniquet used in IVRA is left inflated for a minimum of 20 minutes. Theoretically, this allows time for the local anesthetic to bind to the tissues and, consequently, prevent a large bolus of drug from entering the systemic circulation. However, this tourniquet time appears to be arbitrary, and no safe time interval between anesthetic drug injection and tourniquet deflation has been established.
详细描述
This is a prospective Cohort , controlled , single-blinded , randomized study will be carried out at the department of Anesthesia of Sohag University hospital .
This study will be conducted on 80 trauma patients who will be present for both elective and emergency Hand and Forearm surgery ..
The patients will be allocated to one of four groups :
Early deflation occurs after 20 minutes of induction of IVRA Late deflation occurs after 40 - 60 minutes of induction of IVRA
- Group one ( lidocaine or control LE ) Early deflation
- Group two ( lidocaine , ketorolac LKE) Early deflation
- Group three ( lidocaine Or control LL ) Late deflation
- Group four ( lidocaine , ketorolac LKL ) Late deflation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A normal healthy patient or A patient with mild systemic disease
- •Aged between 20 and 70 years
- •Male or female
- •Schedueled for hand or forearm surgery
排除标准
- •Severe Raynaud's Disease (intermittent arteriolar vasospasm of the distal limbs after cold or emotional stimuli).
- •Sickle Cell Disease (IVRA is relatively contraindicated, unless meticulous exsanguination of the limb takes place prior to cuff inflation).
- •Crush injury to the limb, IVRA may provoke further tissue damage secondary to hypoxia.
- •Patients should be fasting, as there may be a possibility of conversion to a general anaesthetic, alternatively the patient may require sedation in addition to IVRA to improve co-operation.
- •Psychic, uncooperative patients.
- •Patient refusal.
研究组 & 干预措施
Group one ( lidocaine or control LE ) Early deflation
Patients in group one (lidocaine or control group LE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 20 minutes.
干预措施: Group one ( lidocaine or control LE ) Early deflation (Drug)
Group two ( lidocaine , ketorolac LKE) Early deflation
Patients in group two (lidocaine ketorolac LKE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 20 minutes.
干预措施: Group two ( lidocaine , ketorolac LKE ) Early deflation (Drug)
Group three ( lidocaine Or control LL ) Late deflation
Patients in group three (lidocaine or control group LL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 40 minutes.
干预措施: Group three ( lidocaine or control LL ) Late deflation (Drug)
Group four ( lidocaine , ketorolac LKL ) Late deflation
Patients in group four (lidocaine ketorolac LKL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 40 minutes.
干预措施: Group four ( lidocaine , ketorolac LKL ) Late deflation (Drug)
结局指标
主要结局
Efficiency of intravenous regional anesthesia assessed by visual analogue scale
时间窗: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the quality of the sensorial and motor block .
Duration of intravenous regional anesthesia
时间窗: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the duration of the sensorial and motor block .
Efficacy of intravenous regional anesthesia as regard tolerance of tourniquet pain .
时间窗: 6 months
Assessment of lidocaine as anesthetic in IVRA on 40 participants as regard tourniquet pain during hand and forearm surgery .
次要结局
- Role of keterolac as adjuvant to lidocaine in intravenous regional anesthesia as intraoperative & postoperative analgesic(6 months)
研究者
Sherif Salah Ismail
resident doctor at anesthesiology& intensive care unit and pain managment department sohag university hospital
Sohag University
