High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Estimated blood loss
研究概览
简要总结
Since the first spinal fusion by Hibbs 1911, yet anesthesia for correction of scoliosis is challenging due to frequently associated co-morbidities, the extensive nature of surgery and liability for many complications. Among the major concerns for anesthesiologists are the pain and bleeding. Scoliosis correction accounts for massive blood loss that may exceed more than half of blood volume. There are many strategies for blood conservation; however sometimes some of them may not be suitable. For analgesia, the most frequently loco regional analgesic techniques in spine surgery are intrathecal, epidural or local infiltration techniques. infiltration data reviled inconclusive and heterogeneous results. Our purpose is to optimize blood conservation and analgesia through anatomically based modification of the infiltration technique.
详细描述
The most frequently loco-regional analgesic techniques in scoliosis surgery are intrathecal, epidural, caudal morphine, or local infiltrations techniques including ultrasound guided thoracolumbar interfascial plane block. however these techniques possess some limitations in scoliosis surgery. Local anesthetic infiltration was first applied over 35 years ago in lumbar spine surgery as a reliable technique for pain relief. However meta-analysis of data reviled inconclusive and heterogeneous efficacy results.This conflict arise from the differences in the technique and drugs.There are three levels of infiltration; subcutaneous, muscular and perineural. Its timing either pre-incision or post-surgery. Generally the preemptive and deep infiltration offer better analgesia when compared with post-surgical and superficial forms. Different drugs including local anesthetics, epinephrine and adjuvants can be given as a single injection or infusion. Doses and volumes are also different, usually ranging from 10 to 30 ml at a concentration of 0.25% Bupivacaine. the use of epinephrine helps bleeding control Concomitantly, unlike the other techniques, bupivacaine infiltration was combined at three levels in this study; subcutaneous, muscular and neural paravertebral to provide sensory, motor and sympathetic blockade all together. In addition, this drug combination may help to maintain spinal cord perfusion by avoiding deliberate hypotension. The high volume sufficient for proper tissue infiltration combined at three anatomically guided levels for three types of nerves has not been described so far. This research may benefit all spine surgery patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kyphoscoliosis patients subjected for spinal correction.
- •Age 8-18 years.
- •American Society of Anesthesiologists I-II status.
排除标准
- •Patient or parents refusal.
- •Infection at surgical site.
- •Hypersensitivity to amide local anesthetics.
- •Coagulopathy.
- •Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
- •Sever cardiac, respiratory, renal or hepatic impairment.
- •Presence of communication barrier.
研究组 & 干预措施
local anesthetic-epinephrine group
after general anesthesia, the Infiltration cocktail was done by the surgeon at three levels:
- Subcutaneous: before incision at a volume 20 ml/10 cm/side.
- Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume.
- Neural paravertebral: after exposure of the transverse processes. A volume of 5 ml/per each process of the same cocktail, 1 cm deep to the surface of the corresponding process before pedicular screws fixation after negative blood aspiration.
干预措施: Local anesthetic-epinephrine (Drug)
saline group
after general anesthesia, the same infiltration volume and technique using normal saline.
干预措施: Saline (Drug)
结局指标
主要结局
Estimated blood loss
时间窗: Intraoperative
milliliter
Total Morphine consumption.
时间窗: during first 24 hours postoperatively.
milligram
次要结局
- The surgical field visualization for subcutaneous incision(Intraoperative, 10 minutes after skin incision.)
- The surgical field visualization for muscular dissection(Intraoperative, 30 minutes after the thoracolumbar fascia incision,)
- The surgical field visualization for nails insertion(Intraoperative, 30 minutes after the first nail insertion.)
- The surgical field visualization for osteotomy(Intraoperative, 20 minutes after the first osteotomy)
- The operative duration(Intraoperative)
- The number of blood transfusion unites.(intraoperative)
- Nitroglycerin consumption(Intraoperative)
- Fentanyl consumption(intraoperative)
- Atracurium consumption(intraoperative)
- Propranolol consumption(intraoperative)
- Mean blood pressure (MBP)(basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.)
- Mean heart rate (HR)(basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.)
- Inhalational isoflurane concentration(intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction.)
- The number of hypertensive episodes(intraoperative)
- The number of tachycardic episodes(intraoperative)
- Ephedrine consumption(intraoperative)
- The total amount of fluid utilization.(intraoperative)
- Visual analog score(postoperative at 1,4,8,12,16, 20, 24 hours)
- the time to first analgesic request(postoperative for 24 hours)
- Opioid request episodes(postoperative for 24 hours)
- Ambulation time(postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours.)
- Hospital stay(postoperative, till the time of signed discharge order. up to 10 days)
- the Incidence of wound complications.(postoperative till 2 weeks)
- Surgeon satisfaction with the operative filed(within 2 hours from the end of operation)
- Patient satisfaction with analgesia(24 hours after the end of surgery)
- Urine output(intraoperative)
研究者
Alaa Mazy Mazy
Associate professor of anesthesia and surgical intensive care
Mansoura University