Efficacy of Prolonging Intravenous Lidocaine by 72 Hours on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The primary outcome is the incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. deep breathing) at 24 hours after surgery.
研究概览
简要总结
Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group.
In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia.
详细描述
Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group.
In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery.
Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of the surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood samples will also be collected 24 hours after surgery for subsequent measurement of IL-6, and tumor necrosis factor-α (TNF-α). The obtained samples will be labeled, centrifuged, frozen, and stored locally at -80° for subsequent testing.
Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.
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)
盲法说明
The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old
- •American Society of Anesthesiologists(ASA) Ⅰ～III
- •patients scheduled for elective hepatectomy
排除标准
- •body weight < 40 kg or >100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin > 2.5 times the upper limit of normal), renal impairment (creatinine clearance < 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction < 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.
研究组 & 干预措施
Lidocaine group
at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery.
干预措施: Lidocaine Hydrochloride, Injectable (Drug)
placebo group
the same volume of normal saline will be administered during anesthesia.
干预措施: 0.9% normal saline (Drug)
结局指标
主要结局
The primary outcome is the incidence of moderate to severe pain (NRS ≥ 4) during movement (i.e. deep breathing) at 24 hours after surgery.
时间窗: The first 24 hours after surgery
The pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
次要结局
- The incidence of moderate to severe pain at 24 hours after surgery at rest(The first 24 hours after surgery)
- Bowel function recovery(At 3 days after surgery)
- The cumulative morphine consumption at 24, 48 and 72 hours postoperatively(At the end of the surgery，24，48 and 72 hours after surgery)
- The incidence of PONV during the first 72 hours after surgery(At 3 days after surgery)
- The incidence of a composite of postoperative pulmonary complications during hospitalization(during the period from the end of surgery to discharge)
- Length of hospital stay(during the period from the end of surgery to discharge)
- Patient satisfaction scores(72 hours after surgery and before discharge)
- Levels of inflammatory factors ( IL-6, TNF-α) at 24 hours after surgery.(at 24 hours after surgery.)
- The incidence of moderate to severe pain at 48 and 72 hours after surgery at rest and during movement;(At 3 days after surgery)
研究者
Chunling Jiang
Professor
West China Hospital