Comparison Between Levobupivacaine 0.25% and Levobupivacaine With Dexmedetomidine in Ultrasound Guided Modified Pectoral Nerve Block, a Double Blind Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Total postoperative opioid (morphine) consumption
研究概览
简要总结
A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure.
The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .
The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.
详细描述
Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block, if participants meet in- and exclusion criteria and provide written informed consent.
Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.
Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).
Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.
When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •18years and older
- •American Society of Anesthesiologists 1, 2,3,
- •planned for radical mastectomy.
排除标准
- •Neurological problems (central and peripheral)
- •Bilateral mastectomy
- •Body Mass Index > 33,
- •Absolute contra-indication for ketorolac.
- •Allergy/over-sensitiveness to levobupivacaine or local anesthetics of the same class
- •Allergy/over-sensitiveness to dexmedetomidine or other alpha2 agonists (clonidine)
- •Anatomic variations of the breast, pectoral region or axilla, noticed at clinical examination, including a pacemaker, Implantable Cardioverter Defibrillator, Port-a-Cath or other implantable device on the side that needs surgery.
- •Participation in an other clinical trial within a period of four weeks before the beginning of this trial.
- •Coagulopathy
- •Infection or abcess in the region where the Block will be placed.
- •Pregnancy
研究组 & 干预措施
Levobupivacaine
Study Group 1 (Group L): patients undergoing an ultrasound guided modified pectoral nerve block (technique described by Blanco et al[1]) with levobupivacaine 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml) (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
干预措施: Levobupivacaine (Drug)
Levobupivacaine + Dexmedetomidine
Study Group 2 (Group LD): patients undergoing an ultrasound guided modified pectoral nerve block (a technique described by Blanco et al[1]) with levobupivacaine 0.25% 29,5ml + Dexmedetomidine 50µg (0,5ml)with a total volume of 30ml. (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
干预措施: Levobupivacaine + Dexmedetomidine (Drug)
结局指标
主要结局
Total postoperative opioid (morphine) consumption
时间窗: 24 hours post procedure
Milligrams of morphine used by the patient registrated by patient controlled intravenous analgesia delivery device (PCIA) during 24 hours after surgery
次要结局
- Onset of postoperative pain(24 hours post procedure)
- Number of boluses morphine the patient asked for in the first 24 hours postoperative(24 hours post procedure)
- Number of effectively delivered morphine boluses in the first 24 hours postoperatively(24 hours post procedure)
研究者
Hilde Coppejans
data manager
University Hospital, Antwerp