A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery. A Randomized Comparative Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.
研究概览
简要总结
The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have occurred.
The purpose of the present study is to establish the efficacy of the technique of intravenous regional analgesia with a forearm tourniquet using reduced doses of lidocaine.
详细描述
Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly. A conventional Biers block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area.
A mini-Biers block in which the tourniquet is placed on the forearm, has been shown to be a safe and effective way of anesthesia to perform hand and wrist surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions.
Intravenous regional anesthesia (IVRA) or Bier's Block is a simple and effective but underused anesthetic technique for hand and wrist surgery, This technique, introduced by Dr.August Bier in1908, provides complete anesthesia as well as a bloodless field during surgery.
Traditionally, an upper arm tourniquet has been used to sequester the local anesthetic and to create a bloodless Surgical field. Major complications after IVRA with an upper arm tourniquet are rare but are mostly related to local anesthetic systemic toxicity after release of the tourniquet.
Use of a forearm tourniquet has been introduced in 1978 and comes with the big advantage of lower (non-toxic) local anesthetic dosage requirement to produce a good quality of analgesia.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of American Society of Anesthesiologists (ASA) physical status I to II.
- •Both sexes.
- •≥ 21 to 65 years.
- •scheduled for elective hand and wrist surgeries.
排除标准
- •American society of Anesthesiologists (ASA) physical status ≥3 or BMI ≥40
- •Patients will do bilateral hand surgery
- •Local site infection.
- •Allergy to local anesthetics.
- •Patient refusal
- •Patients with pre-existing myopathy or neuropathy on the operating limb.
- •Patients with significant cognitive dysfunction.
- •Chronic analgesic abuser patients.
研究组 & 干预措施
Group A (Arm IVRA) 70 patients
After placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation.
干预措施: Arm intravenous regional anesthesia (Procedure)
Group F (Forearm IVRA) 70 patients
After placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast.
干预措施: Forearm IVRA block (Procedure)
结局指标
主要结局
The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.
时间窗: surgery duration which is around 1.5 hour
the analgesic effectivity of these techniques (graded as "complete" or "incomplete") and divide the effectivity in 4 grades. Grade 1 and grade 2 will be considered "complete" blockade, while grade 3 and grade 4 will be considered "incomplete" blockade. Grade 1: complete motor and sensory blockade. Grade 2: partial motor blockade but no pain. Grade 3: partial motor blockade with mild pain requiring rescue local or opioid analgesia. Grade 4: incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.
次要结局
- Tourniquet time(From start of inflation until deflation of the tourniquet during surgery time which may last up to 90 minutes.)
- Onset time of analgesia(At injection of the local anaesthetic until complete blockade of the sensory nerves during surgery)
- Intraoperative pain score(Every 5 minutes up to 1.5 hours during the surgical procedure)
- Postoperative pain score: Numeric Rating Scale(NRS)(Patients will be observed and data recording will be done every 2 hours for the first 24 hours for postoperative pain)
- Tourniquet tolerance time(From start of inflation until deflation of the tourniquet during surgery)
- General satisfaction of the patient(Assessed on day 1 post surgery)
- Satisfaction with surgical conditions (bloodless field)(At the start of the surgical procedure)