Effect of Addition of Dexmedetomidine During Ultrasound Guided Bilateral Single Shot Erector Spinae Plane Block in Patients Undergoing Posterior Lumbar Interbody Fusion Under General Anesthesia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- changes in Post-Anesthesia Care Unit (PACU) length of stay
研究概览
简要总结
Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).
详细描述
Objectives: Posterior lumbar interbody fusion (PLIF) is the management of choice in double level lumbar (L) spondylolisthesis (L3-L5) after ineffective conservative treatment. We evaluated bilateral ultrasound (US)-guided single shot erector spinae plane (ESP) block at the level of lumbar 3 (L3) vertebra with or without dexmedetomidine (Dex).
Methods: A prospective controlled randomized, double-blind study comparing two groups of patients; each group included 20 patients of double level spondylolisthesis (L3-L5) scheduled for (PLIF) under general anesthesia combined with bilateral US-guided ESP single shot block at (L3). Group I received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally. Group II received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally. Post-Anesthesia Care Unit (PACU) length of stay, the total dose of postoperative analgesics need, postoperative visual analogue score (VAS) at 1h, 6h, 12h, and 24 h after the operation and postoperative complications which related to block or opioids were recorded.
ESP block at combined with (Dex) is a safe, effective block with no complications. Addition of 100µg Dex to preoperative ESP block provided good postoperative opioid-sparing analgesia, facilitated the early emergence and shortened the length of stay in the PACU during (PLIF) for double level spondylolisthesis (L3-L5).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •belonged to the American Society of Anesthesiologists (ASA) physical status I or II
- •either sex
- •aged 18-60 years
- •body mass index less 35 kg/m2
- •complaining from double level lumbar spondylolisthesis (L3-L5)
- •scheduled for elective surgical intervention aimed at lumbar spine fixation by PLIF - under general anesthesia.
排除标准
- •obesity (body mass index > 35 kg/m2)
- •infection of the skin at the site of the needle puncture
- •allergies to either of the study drugs
- •bleeding disorder
- •and recent use of opioid.
研究组 & 干预措施
Group I
received 20 ml of 0. 25% bupivacaine plus one mL normal saline bilaterally.
干预措施: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block (Drug)
Group II
received 20 ml of 0.25% bupivacaine with supplementation of 1 mL containing 100µg dexmedetomidine bilaterally
干预措施: Ultrasound Guided Bilateral single shot Erector Spinae Plane Block (Drug)
结局指标
主要结局
changes in Post-Anesthesia Care Unit (PACU) length of stay
时间窗: at 1hours, 6hours, 12hours, and 24 hours after the operation
assessment of changes in the Post-Anesthesia Care Unit (PACU) length of stay in (minutes) during the first 24 hours was reported.
changes in the total dose of postoperative analgesics need
时间窗: at 1hours, 6hours, 12hours, and 24 hours after the operation
assessment of changes in the total dose of postoperative analgesics need in the first 24 hours were reported.
changes in recovery time
时间窗: at 1hours, 6hours, 12hours, and 24 hours after the operation
assessment of changes in the recovery time length in (minutes) during the first 24 hours was reported.
changes in postoperative visual analogue score (VAS)
时间窗: at 1hours, 6hours, 12hours, and 24 hours after the operation
assessment of changes in the postoperative visual analogue score (VAS)in the first 24 hours was reported. Scoring and Interpretation: Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post-surgical patients who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm) . Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale, not a visual one.
次要结局
未报告次要终点
研究者
Ahmed Said Elgebaly,MD
director
Tanta University