PDF(Pubmed)
Abstract：
BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery.
METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness.
CONCLUSIONS: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.
BACKGROUND: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness.
CONCLUSIONS: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients.
BACKGROUND: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
摘要：
背景：持续疼痛是乳腺癌手术后常见但令人衰弱的并发症。鉴于这种疼痛障碍对患者和医疗保健系统的普遍影响，乳房切除术后疼痛综合征（PMPS）正在成为一个更大的人群健康问题，尤其是随着乳腺癌的预后和生存率的增加。需要预防乳房手术后持续性疼痛的干预措施，以提高乳腺癌幸存者的生活质量。术中静脉输注利多卡因已成为降低PMPS发生率的潜在干预措施。我们的目的是确定这种干预措施对接受乳腺癌手术的患者的最终影响。
方法：计划将是一个多中心，平行组，失明,1:1随机化，1,602名接受乳腺癌手术的患者的安慰剂对照试验。计划进行乳房肿瘤切除术或乳房切除术的成年患者将随机接受1.5mg/kg的静脉注射2％利多卡因推注，并进行麻醉诱导，随后2.0mg/kg/h输注，直到手术结束，或安慰剂溶液（生理盐水）在相同的体积。主要结果是3个月时持续性疼痛的发生率。次要结果包括疼痛发生率和1小时的阿片类药物消耗，1-3天,手术后12个月,除了情感，物理，和功能参数，和成本效益。
结论：本试验旨在为可能预防乳腺癌手术后持续性疼痛的干预措施提供明确的证据。如果这次试验成功,利多卡因输注将作为乳腺癌治疗的标准治疗.这个便宜的，广泛可用，易于实施的干预措施有可能减轻已经患病的患者群体的疼痛和痛苦，降低慢性疼痛管理的大量成本，可能减少阿片类药物的使用，改善患者的生活质量。
背景：该试验已在clinicaltrials.gov上注册（NCT04874038，JamesKhan博士。注册日期：2021年5月5日）。
方法：计划将是一个多中心，平行组，失明,1:1随机化，1,602名接受乳腺癌手术的患者的安慰剂对照试验。计划进行乳房肿瘤切除术或乳房切除术的成年患者将随机接受1.5mg/kg的静脉注射2％利多卡因推注，并进行麻醉诱导，随后2.0mg/kg/h输注，直到手术结束，或安慰剂溶液（生理盐水）在相同的体积。主要结果是3个月时持续性疼痛的发生率。次要结果包括疼痛发生率和1小时的阿片类药物消耗，1-3天,手术后12个月,除了情感，物理，和功能参数，和成本效益。
结论：本试验旨在为可能预防乳腺癌手术后持续性疼痛的干预措施提供明确的证据。如果这次试验成功,利多卡因输注将作为乳腺癌治疗的标准治疗.这个便宜的，广泛可用，易于实施的干预措施有可能减轻已经患病的患者群体的疼痛和痛苦，降低慢性疼痛管理的大量成本，可能减少阿片类药物的使用，改善患者的生活质量。
背景：该试验已在clinicaltrials.gov上注册（NCT04874038，JamesKhan博士。注册日期：2021年5月5日）。
