A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 292
- 试验地点
- 5
- 主要终点
- Comparison of ESP versus PVB on acute postoperative pain
研究概览
简要总结
The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.
详细描述
The block will be performed with IV Remifentanil sedation Target-Controlled Infusion mode at 2ng/ml and oxygen therapy.
For the erector spinae plane block:
The puncture will be performed with ultrasound guidance. The ultrasound probe will be placed parallel to the spine parasagittally at the T3 transverse process level. The needle will be introduced and visualized to the plane of the ultrasound image ("in plane").
The desired injection site is between the fascia of the erector muscle of the spine and the transverse process at the T3 level. The operator ensures the correct localization of the needle with saline solution. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
For paravertebral block:
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 (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:
- •either by breast-conserving surgery with axillary dissection,
- •either by modified radical mastectomy with axillary dissection
- •either by modified radical mastectomy with lymph node dissection
- •either by modified radical mastectomy without axillary
- •Patients aged between 18 and 85 years old.
- •ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
- •Signed informed consent form.
- •Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
- •Patient affiliated to the health care insurance.
排除标准
- •Preoperative consumption of opioid in the patient's current medications within three months before inclusion.
- •Ipsilateral breast surgery during 3 months prior to the inclusion.
- •Allergy to local anaesthetics and morphine and NSAID.
- •Local skin inflammation at the puncture area.
- •Bilateral breast surgery planned at inclusion.
- •Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, Deep Inferior Epigastric Perforator (DIEP), Transverse Rectus Abdominis Musculocutaneous (TRAM)…).
- •Any contra-indication or patient's refusal for regional anesthesia.
- •Male subjects.
- •Pregnant woman or breastfeeding.
- •B blocker medication.
- •Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria.
- •Patient under legal protection.
- •Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.
研究组 & 干预措施
Ropivacaine hydrochloride injected by Erector Spinae block
The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml
干预措施: Ropivacaïne Hydrochloride by Erector Spinae block (Drug)
Ropivacaine hydrochloride injected by Paravertebral block
The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml
干预措施: Ropivacaïne Hydrochloride by Paravertebral block (Drug)
结局指标
主要结局
Comparison of ESP versus PVB on acute postoperative pain
时间窗: 24 hours
Percentage of patients needed morphine during the first two postoperative hours in each treatment arm
次要结局
- Acute early postoperative pain by Visual Analog Scale (VAS)(24 hours)
- Incidence of complications and side effects of each block(30 days)
- Post-operative extend of dermatomes blocked(2 hours)
- Postoperative morphine consumption(2 hours)
- Consumption of remifentanil in the Operating Room (OR)(During the period from the surgical incision to the end of the surgical dissection)
- Percentage of nausea or vomiting(2 hours)