Intraoperative Lidocaine or Dexmedetomidine for Postoperative Pain Modulation After Urethral Reconstruction.

Summary

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.

Conditions

• Urethral Stricture

Interventions

PROCEDURE

Perioperative lidocaine infusion

The 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.

PROCEDURE

Perioperative dexmedetomidine infusion

The 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.

PROCEDURE

Perioperative placebo infusion

The 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.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education

  lead OTHER

Principal Investigators

• Małgorzata Malec-Milewska, MD, Prof. · Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2028-06-30

Completion

2028-07-31

Countries

• Poland

Study Locations