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临床试验/NCT02852421
NCT02852421已完成不适用

Randomized Prospective Study to Evaluate Efficacy and Safety of Single Versus Multiple Injection Ultrasound Guided Paravertebral Blocks for Breast Surgery

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Sensory dermatomal spread

研究概览

简要总结

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgeries resulting in reduced narcotic consumption, reduced nausea, improved quality of recovery, reduced chronic pain and possibly reduced metastasis with breast cancer. Traditionally, PVB is done by multiple injections below T1-T5 transverse processes. With multiple injections, the risk is increased for a pleural, an intraneural, and/or an intravascular injection. Recently, ultrasonography is being used to facilitate PVB. The use of ultrasound imaging enables real-time needle visualization during the procedure. This may improve efficacy and reduce the chances of complication like pneumothorax. Currently, there are no data comparing ultrasound-guided single injection technique with multiple injections technique with regards to extent of spread for PVB. Our objective is to investigate the extent of dermatomal spread of PVB when equal volumes of local anesthetic are injected at one versus five paravertebral sites for patients undergoing major breast surgery. In addition, the investigators wish to compare the performance time and duration of analgesia.

Methodology: After local REB approval, 72 patients undergoing a unilateral mastectomy with or without axillary node dissection will be randomized to receive either single or multiple injections PVB. The PVB will be performed in prone position under real-time ultrasound guidance using a para-sagittal approach.The patients in single injection group will receive single injection PVB at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections. Patients in the multiple injection group will receive five injections of PVB from T1 to T5 level. 5 ml of 0.5% ropivacaine will be injected at each level. Pleural drift will be used as a sign of correct needle tip location and local anaesthetic spread. The pinprick method will be used to assess the extent of dermatomal blockade, 20 minutes following the completion of procedure. All patients will receive a standardized general anesthesia for the surgery. Any adverse events including pneumothorax, epidural spread, LA toxicity/seizure, total spinal, will be recorded.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Females, age 18 to 80 years, scheduled to receive unilateral mastectomy surgery, with or without axillary node dissection
  • •Able to give informed consent
  • •Able to cooperate with study process
  • •Availability of home telephone.

排除标准

  • •Patient refusal or lack of informed consent
  • •allergy to local anesthetic and other medications used in the study
  • •Bilateral mastectomies
  • •Coexisting hematological disorder or with deranged coagulation parameters
  • •Pre-existing major organ dysfunction such as hepatic and renal failure
  • •Significant thoracic kyphoscoliosis
  • •History of previous thoracic surgery.

研究组 & 干预措施

Multiple injection paravertebral blocks

Active Comparator

Patients in this group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% "ropivacaine" was injected at each level.

干预措施: Multiple injection paravertebral blocks (Procedure)

Single injection paravertebral block

Experimental

Patients in single injection group will receive single injection paravertebral blocks at T3-T4 level with 25 ml of 0.5% "ropivacaine" and four subcutaneous sham injections.

干预措施: Single injection paravertebral block (Procedure)

结局指标

主要结局

Sensory dermatomal spread

时间窗: 20 minutes

20 minutes after block performance

次要结局

  • Incidence of complication(24 hours)
  • VAS pain scores in PACU(6 hours)
  • Duration of self-reported numbness at the surgical site(24 hours)
  • Time to performance of procedure(Duration of procedure)
  • Cephalic and caudal dermatomal spread(20 minutes after block performance)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sugantha Ganapathy

Professor

Lawson Health Research Institute

研究点 (2)

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