Analgesic Effect of Perioperative Systemic Lidocaine in Patients Undergoing Unilateral Mastectomy Surgery
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 22
- 主要终点
- 24 Hour Hydromorphone
研究概览
简要总结
The aim of this study is to determine if perioperative systemic lidocaine administration will decrease the amount of opioid analgesics required in women undergoing mastectomy surgery. In addition, patients receiving systemic lidocaine will have a lower incidence of post-mastectomy pain syndrome.
This study will have 2 groups. Participants will be randomized into one of each group. The first group will be administered the drug lidocaine prior to surgery and the second group Group B will be administered saline (salt water). This is a blinded study which means the participant will not know which group they have been assigned. The subjects participation will last 12 months (surveys post operatively).
详细描述
Patients will be recruited up to 21 days prior to the day of surgery. The consent form will be reviewed with the patient, and the patient will be allowed to take a copy home. If the patient does not have an EKG within the past 6 weeks in her medical record, an EKG will be obtained at the time of recruitment. At the time of recruitment, the patient will be randomized using a computer-generated code. Group A will receive lidocaine during surgery, and Group B will receive saline (placebo) during surgery.The study drug will be prepared by the investigator(s). The anesthesiologist and research nurse will be blinded. If necessary in the event of an emergency, these individuals may be unblinded.
Group A (Lidocaine):
Induction: 1.5 mg/kg IV (IBW) bolus, administered prior to Propofol. The maximum loading dose administered will not exceed 150 mg IV Infusion: 33.3 mcg/kg/min IV (IBW), initiated before surgical incision.Discontinue infusion 1 hour after skin closure complete.No other local anesthetics administered intra-operatively
Group B (Saline):
Induction: IV bolus, administered prior to Propofol Infusion: Initiate before surgical incision (rate calculated as if for lidocaine infusion). Discontinue infusion 1 hour after skin closure complete No local anesthetics administered intra-operatively. Baseline thermal quantitative sensory testing (QST) scores will be obtained pre-operatively using TSA-II Neuro Sensory Analyzer (Medoc Advanced Medical Systems, Durham, NC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •Gender: Female
- •ASA Physical Status I-III
- •Non-pregnant
- •Surgery: Unilateral total or segmental mastectomy
- •Language: English speaking
- •Consent: Obtained
排除标准
- •Age: Under 18 or over 65 years
- •ASA Physical Status >III
- •Pregnancy
- •Language: Non-English speaking
- •Allergy to Lidocaine or amide local anesthetics
- •Contraindication to succinylcholine
- •History and/or EKG evidence of conduction defect
- •Renal failure (Creatinine >1.7 mg/dL)
- •Patient expected to remain intubated after procedure
- •Chronic home opioid or steroid use
- •Opioid use within one week prior to procedure
- •Drug or alcohol abuse
- •Inability to use PCA
研究组 & 干预措施
Placebo
Group B using saline as a placebo.
干预措施: Placebo (Drug)
Lidocaine
Group A lidocaine infusion and bolus.
干预措施: Lidocaine (Drug)
结局指标
主要结局
24 Hour Hydromorphone
时间窗: 24 hour
Total IV hydromorphone administered during surgery to 24 hours post surgery
次要结局
- Number of Participants Experiencing Post Operative Nausea(Immediate post operative to 48 hours)
- Number of Participants Experiencing Post Operative Ileus(7 days)
研究者
Christian Altman
Principal Investigator
Northwestern University