Effect of Bilateral Erector Spinae Plan Block in Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative morphine consumption in the first 24 hours
研究概览
简要总结
In this study, it was aimed to evaluate the effects erector spina plane block (ESPB) on postoperative opioid consumption in the first 24 hours and pain scores after colorectal surgery.
详细描述
Colorectal surgery can be applied for many reasons, among these reasons, colorectal cancer (CRC) takes the first place. With the understanding of the pathophysiological effects of analgesics better, the use of regional techniques in providing analgesia for patients undergoing colorectal cancer surgery has come to the fore. Depending on the surgical procedure, pain faced by patients is an important problem that must be deal with in the postoperative period.
In this study, the hypothesis was determined as "Pre-operatively, erector spina plane block (ESPB) performed as part of multimodal analgesia reduces postoperative morphine consumption and pain scores."
The patients were divided into two groups :
Group ESP (erector spinae plan):
In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients were randomly divided into two groups of 30 patients each. In the system where computer generated random numbers (SPSS v23.0, IBM, NewYork, USA) were used, ESP and GA groups were determined at a ratio of 1:1. Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the block procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group. The care provider and investigator were also blinded to the participant.
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
- •Patients aged between 18 and 65 years
- •ASA I , II patients
- •BMI<35 kg/m2 (body weight <100 kg , >45 kg)
- •Patients who underwent colorectal surgery
排除标准
- •Patients who underwent abdominoperineal resection
- •Patients who were evaluated as unsuccessful block in the dermatomal examination performed after the block was applied.
- •Patients diagnosed with OSAS
- •Pregnancy and breastfeeding
- •Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- •Hypersensitivity to local anesthetics or a history of allergy
- •Patients with a history of opioid use longer than four weeks
- •Patients with severe psychiatric diseases such as psychosis or dementia that limit cooperation with the patient.
- •Patients with anatomic deformity ( advanced scoliosis and kyphotic patients. Patients with pectus carinatum and pectus excavatum-like chest deformity )
- •Patients who do not want to participate
- •Patients who have had previous colorectal surgery, excluding diagnostic biopsies
- •Patients who could not be reached by phone to inquire about their pain score at 3rd month.
结局指标
主要结局
Postoperative morphine consumption in the first 24 hours
时间窗: Postoperative day 1
Morphine consumption in the first 24 hours were measured. Patients will be able to request opioids via a PCA device when their VAS score is above 3 at rest and during activity (coughing and deep breathing).
次要结局
- Postoperative pain scores(Postoperative month 3)
- Remifentanil consumption during the surgery(The remifentanil consumption will be recorded from anesthesia induction until the patient is referred to the recovery unit, up to 160 min])
- Incidence of pruitus(Postoperative day 1)
- The number of patient requiring rescue analgesia(Postoperative day 1)
- Number of patients with postoperative nausea-vomiting and need of antiemetic usage(Postoperative day 1)
- Postoperative first oral intake time, first urination, first defecation time, first mobilization time, hospitalization time(Postoperative 7 days on an average)
研究者
Yasemin Burcu Ustun
Professor
Ondokuz Mayıs University