Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4,300
- 试验地点
- 86
- 主要终点
- The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.
研究概览
简要总结
The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.
详细描述
The Trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively, on the incidence of moderate or severe chronic post-surgical pain (CPSP) detected one year following surgery in female patients undergoing elective breast cancer surgery. The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, analgesic efficacy (pain scores and opioid consumption), neuropathic characteristics of CPSP, and psychological and quality of life outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
All trial participants, research coordinators, members of the anaesthesia and surgical teams, pharmacists, theatre and ward staff and all individuals performing patient follow up will be blinded to the patient's treatment allocation. All of the trial committees associated with the study will be blinded, with the exception of the Data Safety and Monitoring Committee (DSMC), who will receive unblinded (open) reports from the independent statistician. Unblinding of the patient's treatment allocation will be possible in exceptional circumstances, and a process will be in place to facilitate unblinding requests.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)*. * this specifically excludes patients undergoing surgery for locoregional recurrence
- •American Society of Anaesthesiologist (ASA) physical scale 1-3
排除标准
- •Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy
- •Where surgery is being performed for locoregional recurrence of breast cancer
- •Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)
- •Re-excision procedures where the margins at the index surgery have been deemed insufficient
- •When immediate autologous reconstruction surgery is planned
- •Where delayed autologous reconstruction surgery on the operative breast within one year is planned
- •Planned use of regional analgesia infusions
- •Impaired cognition
- •Pregnant or lactating females
- •Transgender patients
- •Known metastatic disease
- •History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia
- •History of epilepsy
- •Baseline heart rate < 50 bpm or systolic blood pressure < 100mmHg.
- •Acute coronary event in the last three months
- •Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated
- •Abnormal serum potassium concentration (based upon site laboratory reference ranges)
- •Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)
- •Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)
- •Cardiac Failure (any documented heart failure at peroperative assessment or GP records)
- •Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)
- •Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches
研究组 & 干预措施
Lidocaine
2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.
干预措施: lidocaine 2% and 10% (Drug)
Placebo
0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.
干预措施: Placebo (Drug)
结局指标
主要结局
The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.
时间窗: 1 year post-surgery
Numerical rating scale ≥4 out of 10 for worst pain in the last week - The pain must have been present for at least 3 months prior to the one year assessment (or longer).
次要结局
- The incidence of mild or greater pain at the site of surgery at 1 year after surgery(1 year post surgery)
- Severity of acute postoperative pain at rest(24 hours postoperatively)
- Productivity costs over 1 year following surgery(1 year post surgery)
- Quality-adjusted life years (QALYs) over 1 year following surgery(1 year post surgery)
- Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year.(1 year post surgery)
- Severity of pain at the site of surgery(1 year post surgery)
- Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.(1 year post surgery)
- The incidence of mild or greater pain at the site of surgery at 1 year after surgery(1 year post surgery)
- Postoperative opioid consumption(1 year post surgery (last 24 hours))
- The incidence of mortality at 1 year(1 year post surgery)
- UK NHS costs of care over 1 year following surgery(1 year post surgery)
- Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year.(1 year post surgery)
- Severity of acute postoperative pain at rest(24 hours postoperatively)
- Severity of Acute postoperative pain on movement(24 hours postoperatively)
- The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)(1 year post surgery)
- Incidence of neuropathic symptoms(1 year post surgery)
- Physical functioning(1 year post surgery)
- Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline(1 year post surgery)
- Productivity costs over 1 year following surgery(1 year post surgery)
- Quality-adjusted life years (QALYs) over 1 year following surgery(1 year post surgery)
- The incidence of severe CPSP at 1 year after surgery(1 year post surgery)
- Postoperative opioid consumption(on Day 1)
- Postoperative opioid consumption(3 months (last 24-hours))
- The incidence of severe CPSP at 1 year after surgery(1 year post surgery)
- Severity of pain at the site of surgery(1 year post surgery)
- Incidence of neuropathic symptoms(1 year post surgery)
- Physical functioning(1 year post surgery)
- Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline(1 year post surgery)
- Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.(1 year post surgery)
- The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)(1 year post surgery)
- Severity of Acute postoperative pain on movement(24 hours postoperatively)
- Postoperative opioid consumption(1 year post surgery (last 24 hours))
- The incidence of mortality at 1 year(1 year post surgery)
- UK NHS costs of care over 1 year following surgery(1 year post surgery)
研究者
Prof Tomas Corcoran
Chief Principal Investigator
Monash University