Analgesic and Pulmonary Function Effects of Erector Spinae Plane Block Versus Paravertebral Plane Block for Women's Undergoing Modified Radical Mastectomy; Randomized Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pulmonary Function Tests(PFT)
研究概览
简要总结
postoperative pain following Modified radical mastectomy is severe specially after dissection of tissues .paravertebral plane block provides an excellent postoperative analgesia for women's,but it carry the risk of pneumothorax which it reported in some cases.Erector spinae plane block is a recent block has been mentioned in many case reports as a safe,quick and can be used in outpatient setting. we use a comparative study to compare the postoperative analgesia between both blocks and the affection of postoperative pain following both blocks if any on pulmonary functions.
详细描述
Postoperative pain is one of the commonest problems encountered by anesthesiologists in their practice, especially after radical mastectomy surgeries , in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes.
Postoperative pulmonary complications (PPCs) are the leading cause of death and increase hospital care expenditures in cardiothoracic and non- cardiothoracic surgery. Included under the heading of (PPCs) are respiratory failure, pneumonia, atelectasis, and exacerbation of chronic obstructive pulmonary disease.
Modified radical mastectomy, usually performed for the treatment of breast cancer, is associated with considerable acute postoperative pain and restricted shoulder mobility An estimated 40% of women report significant pain symptoms following mastectomy Poor pain relief has been associated with additional healthcare costs, resource utilization and prolonged inpatient stay after surgery.
the thoracic paravertebral block (TPVB) is the most widely used technique to provide postoperative analgesia after breast surgeries Advantages of a TPVB technique include reduced postoperative pain, analgesic consumption and shorter post anesthesia care unit (PACU) stay There is also evidence to suggest that TPVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura.
Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
Double Blind (caregiver,outcome Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA grade II-III.
- •female patients in the age group of 18-50 yr.
- •undergoing modified radical mastectomy under general anesthesia.
- •BMI <40 kg.m2.
排除标准
- •pre-existing infection at the block site.
- •Coagulopathy.
- •morbid obesity (BMI >40 kg m-2).
- •allergy to local anesthetics.
- •decreased pulmonary reserve.
- •major cardiac disorders.
- •renal dysfunction.
- •pre-existing neurological deficits.
- •psychiatric illness.
研究组 & 干预措施
Paravertebral plane block group
The TPVB will be administered at the T4 level with the patient in the sitting position.The ultrasound probe will be placed 5 cm from the midline in the craniocaudal direction and moved medially to identify the transverse process and parietal pleura. The superior costotransverse ligament was identified as a collection of homogeneous linear echogenic bands alternating with echo-poor areas running from one transverse process to the next. Bubivacaine0.5%, 20 ml will be deposited in the space between the pleura and the costotransverse ligament.
干预措施: Paravertebral plane block (Procedure)
Erector spinae plane block group
the transducer will be placed in a transverse orientation at T5 to T6 to identify the spinous process, lamina, and transverse process .The tip of the transverse process will be centered on the ultrasound screen, and the transducer will be rotated 90 degrees into a longitudinal orientation to obtain a parasagittal view. Depending on the level imaged, 2 or 3 hypoechoic muscle layers were identified overlying the tip of the transverse processes. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superficial to the transverse processes. An 8cm 22-gauge block needle will be Inserted in-plane to the ultrasound beam in a cephalad-to-caudal Direction to place the needle tip between the posterior fascia of Erector spinae and the tip of the targeted transverse process. Following which a total of 20 mL of 0.5%bupivacaine will be injected.
干预措施: Erector spinae plane block (Procedure)
结局指标
主要结局
Pulmonary Function Tests(PFT)
时间窗: preoperative and 24 hours postoperative
Pulmonary function test (PFTs) will be performed for all of them in the day before operation .pulmonary function tests will assess via a portable spirometer (Enraf-Nonius, Model SPIRO 601 Medical Technologies) with the patient in the sitting or semi-recumbent position. PFTs will obtain with the elimination of outliers from data analysis
次要结局
- Hospital stay(72 hours)
- Dermatomal distribution(30 minutes after block will be assessed every 5 minutes)
- Incidence of Side effects and complication during study(24 hours)
- Opioid consumption(24 hours postoperatively)
- Time to first analgesic requirement(24 hours postoperative)
研究者
jehan ahmed sayed
Principal Investigator
Assiut University