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.
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
known allergy to one of the investigated medications
current chronic pain
known chronic use of opioids, gabapentinoids and antidepressants
Parallel
Perioperative lidocaine infusion
Procedure/SurgeryThe study drug infusion will be started prior ti induction of general anesthesia at a rate of 0.9 mL/kg/h and continued for 10 minutes, corresponding to a dose of 1.5 mg/kg lidocaine. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL/kg/h, corresponding to 1.5 mg/kg/h of lidocaine.
Perioperative dexmedetomidine infusion
Procedure/SurgeryThe study drug infusion will be started at a rate of 0.9 mL/kg/h and continued for 10 minutes, corresponding to a dose of 0.6 μg/kg dexmedetomidine. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL/kg/h, corresponding to 0.6 mcg/kg/h of dexmedetomidine.
Perioperative placebo infusion
Procedure/SurgeryThe 0.9% NaCl infusion will be started at a rate of 0.9 mL/kg/h and continued for 10 minutes. Subsequently, the infusion will be continued until placement of the final skin suture at a rate of 0.15 mL/kg/h.
Postoperative opioid consumption following urethral reconstructive surgery
Intravenous buprenorphine consumption
Number of patients with at least one episode of bradycardia
Noted episodes of bradycardia requiring administration of atropine
Number of patients with at least one episode of hypotension
Noted episodes of hypotension requiring administration of vasoactive agents
Intensity of postoperative pain assesses by Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable)
Pain intensity in Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable) at 2,4, 8, 24 and 48 hours postoperatively
Time to first opioid request
The time from emergence of anesthesia to the first dose of buprenorphine
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