Analgesic Efficacy of Two Different Volumes of Local Anesthetics in Ultrasound-guided Modified Approach of Thoracolumbar Block in Patients Undergoing Lumbar Spine Surgeries; a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total morphine consumption in the first 24 hours postoperative
研究概览
简要总结
Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.
There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.
详细描述
The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.
Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy ...). at Kasr Alainy hospital.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Both gender
- •Type of surgery: lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae
- •Physical status ASA I, II.
- •Age 18 to 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •● Patients on preoperative opioid regimen for more than 1 month.
- •Patients with history of previous surgical operations in the lumbar region.
- •Patients with spinal deformities (eg. Scoliosis.....).
- •Hypersensitivity to Bupivacaine.
- •Extensive Lumbar spine surgeries like large tumor excisions, scoliosis correction or more than 2 level spine fixations.
- •Patients with communication difficulties.
- •Lumbar spine operations that will be performed with the patient in any position other than the prone position.
- •Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).
研究组 & 干预措施
mTLIP10
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
干预措施: Thoracolumbar interfascial plane block (TLIP)Technique (Procedure)
mTLIP10
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
干预措施: Anesthetic Management (Procedure)
mTLIP10
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
干预措施: Bupivacaine Injection 10ml (Drug)
mTLIP20
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
干预措施: Thoracolumbar interfascial plane block (TLIP)Technique (Procedure)
mTLIP20
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
干预措施: Anesthetic Management (Procedure)
mTLIP20
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
干预措施: Bupivacaine Injection 20ml (Drug)
结局指标
主要结局
Total morphine consumption in the first 24 hours postoperative
时间窗: 24 hours
次要结局
- Numeric Pain Rating Scale(24 hours)
- Time to first rescue analgesia(24 hours)
研究者
Bassant M. Abdelhamid
Assissnt professor
Cairo University