Comparison Between Thoracic Para-vertebral Block and Segmental Thoracic Spinal Anesthesia in Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the block success rate.
研究概览
简要总结
General anesthesia is the conventional technique used for breast surgery. breast surgery is associated with a high incidence of postoperative pain, it is estimated that over 50 % of women suffer chronic pain following breast cancer surgery. Regional anesthesia is a good alternative to general anesthesia for breast cancer surgery, providing superior analgesia and fewer side effects related to a standard opiate-based analgesia. there is no evident optimal regional techniques for operative procedures on the breast and axilla, like high thoracic epidural, cervical epidural, paravertebral block, intrerpleural block, PECs block, serratus plane block and segmental thoracic spinal anesthesia. Regional anesthesia decreases operative stress, provides beneficial hemodynamic effects especially for critically ill patients and decreases postoperative morbidity and mortality. Also it reduces post-operative nausea and vomiting and provides prolonged post-operative sensory block, minimizing narcotic requirements. Additionally, this application positively affects the early start of feeding and mobilization.
详细描述
Thoracic paravertebral block (TPVB) is an alternative method to general anesthesia for patients undergoing breast surgery, because it provides a safe anesthesia with balanced hemodynamic response with unilateral somatic and sympathetic blockade, allows postoperative analgesia lowering narcotic usage , minimal nausea and vomiting rate, early discharge and low cost.
Segmental thoracic spinal anesthesia have introduced for cardiac surgery in adults and children in the early 1990's. Kowalewski et al., performed over 10000 cases of spinal injections without a single case of spinal/epidural hematoma or any neurological complications, also segmental thoracic spinal anesthesia has been used successfully for laparoscopic cholecystectomy and abdominal surgeries. It has some advantages when compared with general anesthesia and can be a sole anesthetic in breast cancer surgery with axillary lymph node clearance especially in critical cases. Among its advantages are the quality of postoperative analgesia, lower incidence of nausea and vomiting, and shorter recovery time, with the consequent early hospital discharge. The dose of the anesthetic is exceedingly low, compared with lumbar spinal anesthesia, given the highly specific block to only certain nerve functions along a section of the cord, there is no blockade of the lower extremities. This means that a significantly larger portion of the body experiences no venal dilation, and may offer a compensatory buffer to adverse changes in blood pressure intra-operatively. there was no recorded of neurological complications.The incidence of parasthesia in a study with 300 patients subjected to thoracic spinal puncture at T10-11 was 4.67% in the cut needle group and 8.67% in the pencil point needle group, similar to that reported in lumbar spinal anesthesia.The aim of the present study is the comparison between two sole regional anesthetic techniques, thoracic para-vertebral block and segmental thoracic spinal anesthesia in breast cancer surgery especially for critically ill 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
- Double (Participant, Outcomes Assessor)
盲法说明
a dorsal thoracic gauze cover.
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA II, III, IV patients may have:
- •Cardiovascular disease (e.g., rheumatic heart, systemic hypertension, ischemic heart)
- •Lung disease (e.g., bronchial asthma, COPD)
- •Renal disease (e.g., renal failure, polycystic kidney)
- •Liver disease (e.g., cirrhosis, hepatitis)
- •Endocrine disease (e.g., diabetes mellitus)
排除标准
- •Patient refusal
- •Contraindication to regional anesthesia (coagulopathy, local infection),
- •Spinal deformities.
- •An allergy to α 2 adrenergic agonist local anesthetic drugs.
研究组 & 干预措施
paravertebral group
ultrasound guided, in sitting position, or lateral position, at T2 and T4 levels, using 22 G spinal needle, in plane technique, traversing the costo-transverse ligament
干预措施: paravertebral group (Other)
spinal group
Ultrasound guided, In the lateral decubitus or sitting position, the puncture performed via para-median approach, at the T4-T5 or T5-T6 interspace, with a 27G spinal needle. After piercing the ligamentum flavum, the needle's stylet removed and the hub observed for free flow of CSF; injection when there is a flow of clear CSF.
干预措施: spinal group (Other)
结局指标
主要结局
the block success rate.
时间窗: within 30 min of injection
in number, defined as complete sensory block in all dermatomes (T1-T6 ).
次要结局
- Total atropine consumption(intraoperative)
- Total Midazolam consumption(intraoperative)
- Mean blood pressure(0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.)
- Total ephedrine consumption(intraoperative)
- The onset time of lower limb motor block (Bromage 3)(5, 10, 15, 20, 25, 30 minutes after injection.)
- The duration of lower limb motor block (Bromage 0)(30, 45, 60, 90,120, 150 minutes after injection.)
- Ramsey sedation scale(0 (basal), then1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.)
- Heart rate(0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.)
- Systolic blood pressure(0= basal, then 1, 5, 10, 15, 30, 45, 60, 75, 90, 120 minutes from injection time, then 1, 4, 5, 6, 7, 8, 12, 18, 24 hours starting after the end of operation.)
- Visual analog scale(at 0, 4, 5, 6, 7, 8, 12, 18, 24 hours postoperative.)
- The total mepridine consumption.(postoperative for 24 hours.)
- satisfaction of the patient(after 24 hours from the end of operation.)
- The paravertebral onset of sensory block(5, 10, 15, 20, 52, 30 minutes after injection.)
- The spinal onset of sensory block(2, 4, 6, 8, 10, 12, 14 minutes after injection.)
- The power of hand grip (T1/ C8)(5, 10, 15, 20, 52, 30 minutes after injection.)
- The power of wrist flexion (C8/C7)(5, 10, 15, 20, 52, 30 minutes after injection.)
- The power of elbow flexion (C6/ C5)(5, 10, 15, 20, 52, 30 minutes after injection.)
- Hypotension episodes(Intraoperative and postoperative for 24 hours.)
- Bradycardia episodes(Intraoperative and postoperative for 24 hours.)
- Hypoxia episodes(Intraoperative and postoperative for 24 hours.)
- incidence of nausea(Intraoperative and postoperative for 24 hours.)
- incidence of vomiting(Intraoperative and postoperative for 24 hours.)
- the incidence of pneumothorax.(intraoperative and postoperative for 6 hours.)
- The incidence of post-dural puncture headache.(postoperative for 72 hours.)
- The duration of upper limb motor block,(15, 30, 45, 60, 90 minutes after injection.)
- satisfaction of the surgeon(within 2 hours from the end of operation.)
研究者
Alaa Mazy
Associate professor of anesthesia and surgical intensive care
Mansoura University