Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
研究概览
简要总结
The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. The study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. Intralesional catheter is placed at the end of surgery. In the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS >4. From the second postoperative day morphine PCA is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use.
Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. Patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3 month is performed to investigate pain chronicization.
Surgical evaluation is provided, also to establish any catheter-related infective or healing complication.
Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process.
A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.
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, Investigator)
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
- •F; age 18 to 70
- •American Society of Anesthesiologists (ASA) I e II;
- •breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;
- •immediate sub-pectoral prosthetic reconstruction;
- •signed informed consent.
排除标准
- •preexisting pectoral, axillar, thoracic homolateral pain
- •habitual opioid consumption;
- •drug-alcoholics addiction ;
- •ICU postoperative recovery;
- •kidney failure (creatinin > 2 g/dl, creatinin <clearance 30 ml/h) and/or hepatic failure (cholinesterase < 2000 UI);
- •cardiac arrhythmias o;
- •Epilepsy;
- •Psychiatric, cognitive disorders, mental retardation;
- •Coagulopathies (INR > 2, activated partial thromboplastin time - aPTT>44 sec);
- •platelet count less than 100.000/mm3;
- •BMI > 30;
- •Allergies to study drugs.
研究组 & 干预措施
Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
干预措施: Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia) (Drug)
Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
干预措施: Levobupivacaine continuous infusion (Drug)
Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
干预措施: intrawound infusion catheter (Device)
Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
干预措施: morphine (Drug)
Levobupivacaine
Levobupivacaine Patient Controlled Infusion 5 ml 0,25%, lock out 2 hours
干预措施: Patrol (Drug)
Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
干预措施: saline (Drug)
Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
干预措施: Levobupivacaine continuous infusion (Drug)
Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
干预措施: intrawound infusion catheter (Device)
Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
干预措施: morphine (Drug)
Saline
patient controlled infusion 5 ml bolus, lock out 2 hours
干预措施: Patrol (Drug)
结局指标
主要结局
reduction in oral Tramadol-Paracetamol combination consumption from 2nd to 14th day after mastectomy
时间窗: from day 2 to 14
次要结局
- incidence of catheter-related surgical complications(up to 1 month)
- reduction in pain values at rest and movement in treatment group(14 days)
- earlier upper limb rehabilitation(up to 1 month)
- different chronic pain incidence(up to 3 months)
- incidence of drug-related side effects(up to 14 days)
- earlier return to social activities and good quality of life(up to 1 month)
研究者
Massimo Allegri
MD
Fondazione IRCCS Policlinico San Matteo di Pavia