Analgesic Efficacy of Fascia Iliaca Compartment Block With Bupivacaine Versus Bupivacaine With Dexamethasone or Magnesium Sulphate for Dynamic Hip Screw Surgeries Randomized Double Blinded Comparative Study
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Analgesia
研究概览
简要总结
The aim of this study is to evaluate the analgesic efficacy of fascia iliaca compartment block using bupivacaine versus bupivacaine with dexamethasone or magnesium sulphate for dynamic hip screw surgery under spinal anesthesia.
The primary outcome will be the duration of effective analgesia from FICB till the first analgesic dose is required,the secondary outcomes will be the severity of postoperative pain as will be assessed by the visual analogue scale and the total dose of pethidin for rescue analgesia.
详细描述
Different modes of analgesia are given prior to neuraxial blockade for pain relief like non-steroidal anti-inflammatory drugs (NSAID), opioids and peripheral nerve blocks such as, femoral nerve block, 3 in 1 block or fascia iliaca compartment block (FICB).
FICB is believed to be most beneficial compared to other procedures because of its safety and efficacy . FICB provides blockage of at least two of the three major nerves that supply the medial, anterior and lateral thigh with one simple injection, namely the femoral and lateral femoral cutaneous nerves.
FICB is an anterior approach to the lumbar plexus. The pop technique using fascial click had a low success rate of 35% - 47% .However, as the FICB was performed under real-time ultrasound guidance, the success rate was increased up to 82- 87%, leading to an increased interest in FICB as a postoperative analgesia option for hip and knee surgical procedures .
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
- Double (Participant, Care Provider)
盲法说明
The anesthetists who will prepare the drug and who will collect the data will be blinded to the study protocol
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
- 否
入选标准
- •American Society of Anesthesiology physical status (ASA) I & II of both sex.
- •Age between 20 and 70 years.
- •Patients with traumatic hip fracture presenting for elective or emergency dynamic hip screw (DHS) fixation under spinal anesthesia.
排除标准
- •Patient refused to give consent
- •Patients with history of allergy to dexamethasone, magnesium sulphate or bupivacaine.
- •Patients with contraindications to spinal anesthesia.
- •Previous surgery in the affected hip, infection at the injection site, multiple fractures.
- •Peripheral neuropathy.
- •Use of analgesics within 8 hours before the spinal block.
- •Inguinal hernia, and femoral artery graft.
研究组 & 干预措施
the control group
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
干预措施: Bupivacaine (Drug)
Group dexamethasone/Bupivacaine:
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml).(
干预措施: Dexamethasone/bupivacaine (Drug)
Group Magnesium sulphate/Bupivacaine
Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
干预措施: Magnesium Sulfate/bupivacaine (Drug)
结局指标
主要结局
Analgesia
时间窗: duration from the end of surgery till the first time to ask for post operative analgesia within the first 12 hours after surgery
the duration of effective analgesia will be considered as the duration after performing the FICB till the patient ask for first analgesic dose ,in this case pethidin 25 mg will be given intravenously
次要结局
未报告次要终点
研究者
Samaa Rashwan
Principal Investigator
Beni-Suef University