Effects of Intravenous Lidocaine and Dexmedetomidine Infusions on Postoperative Pain and the Development of Chronic Pain Following Urethral Reconstruction Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative opioid consumption following urethral reconstructive surgery
研究概览
简要总结
The development of chronic postoperative pain (CPP) following surgery is influenced by several factors, among which the intensity of acute postoperative pain in the immediate perioperative period and mechanisms related to nerve fiber injury play a crucial role. Previous studies have demonstrated that factors such as the severity of early postoperative pain, patient age, and the extent of surgical intervention may increase the risk of transition from acute to chronic pain. In recent years, growing attention has been directed toward anesthetic techniques and adjuvant analgesics (co-analgesics) administered during surgery, which may potentially reduce the incidence of CPP.
The aim of this study is to evaluate the effects of intraoperative intravenous infusions of dexmedetomidine or lidocaine during urethral reconstructive surgery on postoperative pain intensity, patient-reported quality of recovery, and the incidence and characteristics of chronic postoperative pain, including its neuropathic component. In particular, the study will investigate whether administration of these agents reduces pain intensity during the first 48 hours after surgery-which, according to existing evidence, may correlate with the risk of CPP development-and whether intraoperative infusion of lidocaine or dexmedetomidine translates into reduced pain severity and a lower risk of neuropathic pain at long-term follow-up (3, 6, and 12 months after surgery).
An important aspect of this project is that both investigational drugs-lidocaine and dexmedetomidine-have an established role in routine anesthesiology practice, and their safety profiles are well characterized and extensively documented in the medical literature. Intravenous lidocaine infusion has been used for many years as part of multimodal perioperative analgesia; numerous randomized controlled trials and meta-analyses have confirmed its efficacy in reducing postoperative pain intensity and opioid requirements, with a low risk of adverse effects when administered at therapeutic doses. Dexmedetomidine has been routinely used for years both in intensive care units and as a component of general anesthesia across a wide range of surgical procedures. Its analgesic, anxiolytic, and opioid-sparing effects have been supported by a substantial body of clinical evidence, and the doses used in the present protocol are consistent with established clinical practice.
详细描述
Lidocaine and dexmedetomidine are drugs with a long history of clinical use in anesthesiology and intensive care medicine, and their safety has been extensively documented. Intravenous lidocaine infusion at therapeutic doses constitutes an established component of multimodal perioperative analgesia. Its efficacy in reducing postoperative pain intensity, decreasing opioid requirements, and attenuating the inflammatory response to surgical injury has been demonstrated in numerous prospective randomized trials and meta-analyses. Dexmedetomidine, a selective α₂-adrenergic receptor agonist, is routinely used both for sedation and analgesia in intensive care units and as a component of balanced anesthesia in a wide range of surgical procedures. Its analgesic, sympatholytic, and opioid-sparing properties, together with its favorable effects on hemodynamic stability, have been supported by a substantial body of clinical evidence. The dose ranges employed in the present protocol fall within the limits recommended by current guidelines and are consistent with established clinical practice.
The objective of this study is to determine whether the pharmacological properties of these two agents may be beneficial in preventing chronic postsurgical pain in patients undergoing urethral reconstructive surgery, an area in which high-quality methodological evidence remains scarce.
b) Detailed Methodology Study population The study will enroll patients aged 18-75 years with physical status classification of American Society of Anesthesiology status (ASA) I-III who are scheduled to undergo urethral surgery (e.g., urethral reconstruction, urethroplasty, or treatment of urethral strictures).
Study Design
- Recruitment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Perioperative infusion content known only to investigator that is responsible for infusion preparation and is not involved in patient's care.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA status less or equal 3
- •Scheduled for reconstructive surgery of urethra
- •Able to understand information provided and to sign informed consent for participation in the study
排除标准
- •known allergy to one of the investigated medications
- •current chronic pain
- •known chronic use of opioids, gabapentinoids and antidepressants
研究组 & 干预措施
Perioperative lidocaine infusion
Intravenous lidocaine bolus of 1.5 mg/kg administered over 10 minutes before induction of anesthesia, followed by continuous infusion at 1.5 mg/kg/h until the end of surgery.
干预措施: Perioperative lidocaine infusion (Procedure)
Perioperative dexmedetomidine infusion
Intravenous dexmedetomidine bolus of 0.6 mcg/kg administered over 10 minutes before induction of anesthesia, followed by continuous infusion at 0.6 mcg/kg/h until the end of surgery
干预措施: Perioperative dexmedetomidine infusion (Procedure)
Perioperative 0.9% NaCl infusion
The infusion of 0.9% NaCl will then be started at a rate of 0.9 mL/kg/h and continued for 10 minute. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL/kg/h.
干预措施: Perioperative placebo infusion (Procedure)
结局指标
主要结局
Postoperative opioid consumption following urethral reconstructive surgery
时间窗: 24 hours
Intravenous buprenorphine consumption
次要结局
- Number of patients with at least one episode of bradycardia(24 hours)
- Number of patients with at least one episode of hypotension(24 hours)
- Intensity of postoperative pain assesses by Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable)(48 hours)
- Time to first opioid request(24 hours)
- Number of patients with at least one reported episode of nausea(24 hours)
- Number of patients with at least one episode of vomiting(24 hours)
- Quality of Recovery - 15 score (QoR-15, 0-150, 0 = very poor recovery, 150 = excellent recovery)(48 hours)
研究者
Bartosz Horosz, MD
MD,PhD
Centre of Postgraduate Medical Education