Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Maximal value of pain intensity according to the numerical scale within the six first hours
研究概览
简要总结
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.
详细描述
The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.
An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Affiliated to a national insurance scheme
- •Having signed the informed consent for this study
- •Score of American Society of Anesthesiology ( ASA) 1-3
- •Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.
排除标准
- •Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
- •Pregnant or breast-feeding women according to French law.
- •Vulnerable people.
- •Patients participating in another research
- •Allergy with local anesthetics.
- •Severe coagulopathy.
- •Chronic painful Patients (long-term treatment by analgesics)
- •Contraindication to use analgesics of the protocol.
- •Change of breast prostheses
研究组 & 干预措施
Control group (1)
The PECS Blocks are not (1) performed.
PECS group (2)
The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side.
干预措施: Ropivacaine after dilution with sodium chloride 0.9% (Drug)
结局指标
主要结局
Maximal value of pain intensity according to the numerical scale within the six first hours
时间窗: up to First six postoperative hours
次要结局
- Maximal value of the pain at day 1 and until day 5(Five days)
- Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire(Five days)