Improvement of Analgesia With Addition of Pectoral Nerve Block to Thoracic Paravertebral Blocks in Unilateral Total Simple Mastectomy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Total opioid consumption in post anesthesia care unit (PACU)
研究概览
简要总结
Our routine practice for patients undergoing mastectomy is to include paravertebral peripheral nerve blockade for postoperative analgesia. This study investigates whether the addition of another nerve block targeting the pectoral nerves will improve that analgesia.
详细描述
Randomization:
20 patients will be randomized into 2 groups. Both groups will receive paravertebral blocks with 4 mL of 0.5% ropivacaine at each of six levels.
Group A: Active group with 10 cc of 0.375% ropivacaine (16) pectoral nerve block Group S: Placebo group with 10 cc of normal saline for pectoral nerve block
Blinding:
The injectate contents for the lateral pectoral nerve block will be blinded to all personnel involved in performing the block, all personnel involved in the general anesthesia and all personnel involved in assessing the patient for pain in the postoperative recovery period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older
- •Able to provide own consent
- •Simple mastectomy at University of New Mexico Hospital without planned axillary surgery
排除标准
- •Spinal deformity or pathology
- •Chest wall deformity or pathology
- •Bilateral simple mastectomy
- •Refusal of regional anesthesia
- •Chronic pain
- •History of recent drug or alcohol abuse
- •History of recent psychiatric problems
- •Allergies to lidocaine or ropivacaine
- •Allergies to fentanyl or hydromorphone
- •Surgery that extends beyond the original plan to include axillary exposure
研究组 & 干预措施
Group A
Paravertebral peripheral nerve blockade with with 4 mL of 0.5% ropivacaine at each of six levels, plus 10 cc of 0.375% ropivacaine for pectoral nerve block
干预措施: 10 cc of 0.375% ropivacaine pectoral nerve block (Drug)
结局指标
主要结局
Total opioid consumption in post anesthesia care unit (PACU)
时间窗: Up to 8 hours
次要结局
- Postoperative nausea and vomiting (PONV)(Up to 8 hours)
- Maximum pain score in PACU (numerical rating scale)(Up to 8 hours)
- Patient satisfaction with block(1 day)
- Time to meet PACU discharge criteria(Up to 8 hours)
研究者
Timothy R Petersen
Research Information Specialist
University of New Mexico