A Prospective Evaluation of the Addition of Intraoperative Intravenous Lidocaine Infusion to General Anesthetic in Total Abdominal Hysterectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of intravenous lidocaine infusion administered during general anesthesia in:
- Reducing length of hospital stay following total abdominal hysterectomy
- Reducing postoperative analgesic requirement following total abdominal hysterectomy.
Hypothesis:
The addition of an intraoperative lidocaine infusion to a balanced anesthetic technique will result in up to 50% of patients being discharged after postoperative day 2 compared with the current 21%. Also, it will result in a 30% reduction in opiod consumption during the first 48 hours following total abdominal hysterectomy.
Assumption:
Patients in the intervention and control groups will be titrated to approximately equal analgesia because they will self-administer enough pain-controlling medications to make their postoperative pain experience the same.
Primary outcomes:
- Length of hospital stay
- Total opioid use at 48 hours postoperatively
Secondary outcomes. The following data will be collected and analyzed:
- Intraoperative data: BIS scores (to control depth of anesthesia); intraoperative serum lidocaine levels; intraoperative opioid use
- Opioid use in the recovery room
- Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours
- Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours
- Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively
- Incidence of side effects that can be attributed to local anesthetic toxicity
- Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively
- Time of first flatus and first bowel movement.
详细描述
Provide the rationale for the study (see list of references attached separately).
Provide the rationale for the study (see list of references attached separately).
Adequate postoperative pain control is still a major problem for many surgical patients. Identifying better ways of controlling pain during and after surgery remains an ongoing goal of research in anesthesia. Continuous infusion of IV lidocaine has been identified in the anesthetic literature as a valuable supplement to general anesthesia. Approximately 20% of all total abdominal hysterectomies at The Ottawa Hospital today are done using a continuous IV lidocaine infusion in addition to general anesthesia. Considering its low cost, ease of administration, and low incidence of side effects, lidocaine presents an attractive anesthetic option.
However, there have been only a few randomized controlled trials to date that have assessed the effect of IV lidocaine on a patient's pain control. These trials were small single center studies that require independent validation at other institutions and in other surgical populations. In the previous trials, the standard anesthetic technique was not as well controlled as it will be in this trial. If approved this study will add to the scant but promising literature concerning peri-operative lidocaine use for analgesia.
- Lidocaine infusion supplements general anesthesia and improves analgesia. Lidocaine has been used to supplement general anesthesia for over 50 years (1). It has a MAC sparing effect that allows reduction of other anesthetic agents in a balanced anesthetic technique (1). Lidocaine infusions improve pain scores in burn patients and provide sufficient analgesia without the addition of an opioid analgesic (3). Its use is well established in chronic neuropathic and ischemic pain (6,7). Over the last decade, its use in the management of acute pain and pre-emptive analgesia has increased. Studies demonstrating improved pain scores with movement and at rest in major abdominal surgeries and radical retropubic prostatectomy have been published (2,5,8).
- IV Lidocaine infusion dose and toxicity (2,3,4,5,6,7,10). Lidocaine toxicity does not occur with plasma levels below 5 mcg/mL. Currently reported dosing vary between 'no IV bolus' to 3 mg/kg/hr IV bolus followed by 1.5 to 3 mg/kg/hr infusion rates. These doses generally result in plasma levels of 1.3-3.7 mcg/mL. There is no increase in local anesthetic toxicity at these plasma levels compared to placebo. In one study up to 2.6 mg/kg/hr of lidocaine had been infusing for 24 hours after the end of surgery with no reported side effects attributed to local anesthetic toxicity (4).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and able to give informed consent.
- •Age 30-69 inclusive;
- •ASA (American Society of Anesthesiologists) class I or II patient: (I - healthy with no systemic disease, II - systemic disease with no functional limitation);
- •Body Mass Index (BMI) of 18.5-30.
排除标准
- •Patients undergoing elective total abdominal hysterectomy at The Ottawa Hospital and unable to give informed consent., unable to provide informed consent, or unable to use patient controlled analgesia.
- •Patients under age 30 or over age 70;
- •ASA III, IV and V class patients (III - systemic disease causing functional impairment; IV - systemic disease that is a constant threat to life; V - not expected to survive with or without surgery);
- •Obese patients (BMI>30) or undernourished (BMI<18.5) (9);
- •Unable to use patient controlled analgesia;
- •Any history of liver dysfunction;
- •Renal insufficiency defined as a creatinine clearance <50mL/min as calculated using the Cockroft-Gault formula (11);
- •History of seizure disorder;
- •Hypersensitivity or allergy to amide type local anesthetics;
- •Hypersensitivity or allergy to any of the following opiods: morphine, hydromorphone, meperidine, fentanyl;
- •Any chronic pain syndromes or opioid use greater than once per week.
研究组 & 干预措施
Lidocaine
IV lidocaine in OR as described in methods
干预措施: Lidocaine Intravenous Infusion (Drug)
结局指标
主要结局
Length of hospital stay
Total opioid use at 48 hours postoperatively
次要结局
- Intraoperative data: BIS scores (to control depth of anesthesia)
- Intraoperative serum lidocaine levels
- Intraoperative opioid use
- Opioid use in the recovery room
- Patient Controlled Analgesia (PCA) morphine requirements postoperatively up to 48 hours;
- Oral pain controlling medication use up to 48 hours postoperatively if IV PCA discontinued before 48 hours;
- Verbal Analogue Scale (VAS) pain scores in recovery room and during first 2 days post-operatively;
- Incidence of side effects that can be attributed to local anesthetic toxicity;
- Incidence of nausea and vomiting and anti-emetic use up to 48 hours postoperatively;
- Time of first flatus and first bowel movement.