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临床试验/NCT03599635
NCT03599635已完成4 期

Ultrasound-guided Pec Infiltration With Liposomal Bupivacaine for Breast Surgery: A Prospective Randomized Study

University of Minnesota1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
112
试验地点
1
主要终点
Total Opioid Use

研究概览

简要总结

The purpose of this study is to compare pain control after breast surgery using either liposomal bupivacaine or bupivacaine when infiltrated during an ultrasound guided pectoralis 1 and 2 block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.

详细描述

For the Pec infiltration, the patient will be in the supine position. The pectoralis major and pectoralis minor muscle layers will be identified via ultrasound. Using sterile technique, a nerve block needle will be inserted and advanced under ultrasound guidance until it is below the fascial covering of the pec minor muscle layer. Gentle aspiration for air or blood will be performed in 5cc incremental doses. Then injection of 10 mL of bupivacaine 0.25% with epinephrine 1:200,000 and 10mL of a mixture of liposomal bupivacaine and saline (5 mL liposomal bupivacaine and 5 mL saline) for a total injection for pec 1 block of 20 mL. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection the needle will be removed. The investigators will then use the ultrasound probe to identify the second rib on anterolateral chest wall and move the probe to the 4th rib. Here the investigators will identify the pec minor and serratus anterior muscles. They will advance their needle under ultrasound-guidance beneath pec minor and above serratus anterior. Here an injection 10 mL 0.25% bupivacaine with epinephrine 1:200,000 followed by 20 mL mixture of 15 mL liposomal bupivacaine and 5 mL saline for a total volume of 30ml for Pec 2. block will occur.

Upon completion of the injection, the needle will then be removed and the patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure.

If deemed necessary for coverage the surgeon will be allowed to inject additional local anesthetic up to a maximum of 40 mL of 0.25% bupivacaine. This will be noted in the chart.

For the surgeon infiltration, the patient will be brought directly to the operating room where intraoperative anesthetic with an opioid-sparing MAC technique will be provided as described below. Just prior to the skin incision, 0.25% bupivacaine will be used to infiltrate the dermis and subcutaneous space in the proposed incision. Throughout the procedure, additional incisional bupivacaine infiltration into the surrounding tissues will be performed as needed for local anesthesia. A total of up to 30 mL of 0.25% bupivacaine will be divided equally for the two sides of the incision. An additional 5 mL of 0.25% bupivacaine will be infiltrated into the pectoralis major muscle at the deep margin of resection. Accidental intravascular injection is minimized by continuous needle movement and frequent aspiration.

The following vital signs will be monitored throughout the procedure: Heart rate, blood pressure, oxygen saturation, and respirations, and patient's state of consciousness. The investigators will monitor the patient until they are brought to the operating room for surgery.

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 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • • All patients undergoing partial mastectomy procedures.
  • Ages 18-75

排除标准

  • • Patient on chronic anticoagulation
  • Pregnant women
  • Non-english speaking patients
  • Any individuals who are unable to give informed consent
  • Any individual with diminished capacity to give informed consent
  • Allergy to local anesthetics
  • Patients who remain intubated overnight after surgery or who are unable to provide information regarding their pain immediately postoperatively
  • Daily use of opioid for more than three weeks
  • Significant liver disease, defined as liver enzymes greater than 3x the upper limit of normal
  • Lack of patient cooperation including those patients who refuse a MAC anesthetic
  • Contraindication to regional anesthesia
  • Infection at injection site
  • Inability to guarantee sterile equipment or sterile conditions for the block
  • Patient refusal
  • Severe Coagulopathy or bleeding disorder

研究组 & 干预措施

liposomal bupivacaine

Experimental

These patients will receive liposomal bupivacaine for a pectoralis block infiltration by the anesthesiologist.

干预措施: liposomal bupivacaine (Drug)

bupivacaine

Active Comparator

These patients will receive incisional bupivacaine infiltration by the surgeon.

干预措施: Bupivacaine (Drug)

结局指标

主要结局

Total Opioid Use

时间窗: time from end of surgery through 72 hours after surgery

Description: To determine if liposomal bupivacaine Pec infiltration provides decreased peri-operative opioid usage when compared to incisional bupivacaine infiltration.

次要结局

  • Maximal Pain Scores - 1 Hour(1 hour)
  • Maximal Pain Scores - 2 Hours(2 hours)
  • Maximal Pain Scores - 6 Hours(6 hours)
  • Maximal Pain Scores - 24 Hours(24 hours)
  • Maximal Pain Scores - 48 Hours(48 hours)
  • Maximal Pain Scores - 72 Hours(72 hours)
  • Improved Quality of Recovery Score(1 year)
  • Effect in Patients With Breast Surgery(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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