A Prospective, Randomised Double Blinded Study Comparing a Pectoral Nerve Block With Non-targeted Local Anaesthetic in Bilateral Breast Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- targeted question as to which breast is more painful
研究概览
简要总结
Effective postoperative pain control is an essential component of surgery. Adequate analgesia improves patient comfort and satisfaction, thereby permitting earlier mobilisation, faster recovery and less likelihood of complications.The majority of surgeons will place 10ml of local anaesthetic into the breast pocket or inject it into the breast skin following breast surgery. A more specific technique is to identify the nerves supplying the breast and put the local anaesthetic directly around them (Pec block). This nerve block has recently been described and is increasingly being used by anaesthetists for surgery under local anaesthetic or for post-operative analgesia. It has been shown to provide better and more specific pain relief in several studies.
Anaesthetists use an ultrasound machine to identify the anatomical landmarks for the nerves and they inject into the vicinity. They do not have direct vision and there is a risk of causing morbidity or the block not being effective. It is much easier for a surgeon to apply the block, as they can see the anatomical landmarks. Despite this, very few surgeons are aware of the technique.
The study group consists of patients undergoing bilateral cosmetic breast surgery at BMI Edgbaston and Priory hospitals and Spire Parkway and Southbank hospitals in Birmingham and Worcester. If a patient consents to being involved in the research, they will have one breast randomised to receiving a pec block and the contralateral (opposite) breast will receive the same amount of local anaesthetic placed in the breast pocket in a non-targeted fashion. The patients and researcher will be blinded as to the allocation. Patients will complete a verbal numeric pain score for each breast at set intervals until they are discharged.In addition, the investigators will specifically ask which breast is the most painful at each time point.
The results of the study may improve patient care.
详细描述
The investigators' intention is to randomise all patients undergoing bilateral breast surgery into receiving a specific pec block in one breast and a standard infiltration of non targeted anaesthesia into the other breast. 10ml 0.25% Chirocaine will be used for each breast.
All patients attending the plastic surgery clinic at BMI Edgbaston, BMI Priory, Spire Parkway and Spire Southbank and requesting bilateral breast surgery will be approached to take part in the study. They will be given information to take home and an opportunity to ask any questions about the study.
All consenting patients who meet the inclusion criteria will have one breast randomised into a study group (pec block) and the other into a control group (standard local anaesthetic infiltration). Patients will be randomised by a computer generated code. The patient and researcher will be blinded. By necessity, the surgeon will be aware of the randomisation but will have no involvement in data collection or analysis of results.
Both groups will receive standard post-operative care and follow up. A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen. The investigators will prospectively record post operative pain as rated by a verbal numerical rating scale at 0, 3, 6, 9 and 12 hours post-operatively and at 24 hours. In addition the investigators will record which breast the patient indicates is the most painful and any post-operative complications throughout the study period . The expected recruitment period is six months.
If patients consent to inclusion in the study they will sign a consent form at a second appointment or on the day of surgery. The ward and recovery nurses already have experience in administering a VNRS for pain control.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient requesting a bilateral breast procedure (reduction, mastopexy or augmentation).
- •Patient willing to sign the informed consent form agreeing to its items after explanation of the study by the operating surgeon.
排除标准
- •Declining to give written consent.
- •History of allergy to chirocaine local anaesthetic.
- •Prior breast surgery.
- •Chronic pain disorder.
- •Significant medical co-morbidities.
结局指标
主要结局
targeted question as to which breast is more painful
时间窗: 3 hours post-operatively
patient is asked which breast is more painful
次要结局
- verbal numeric rating scale(VNRS)(3 hours post-operatively)
研究者
Anne Dancey
Consultant Plastic Surgeon
BMI Healthcare