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

NCT07676942 | Not Yet Recruiting

• 1 other identifier: BMG Neuropathic Pain
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

urethral reconstruction; buccal membrane graft; postoperative pain; neuropathic pain; lidocaine; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption following urethral reconstructive surgery

  Intravenous buprenorphine consumption

  24 hours

Secondary Outcomes (7)

• 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

Study Arms (3)

Perioperative lidocaine infusion

EXPERIMENTAL

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.

Procedure: Perioperative lidocaine infusion

Perioperative dexmedetomidine infusion

EXPERIMENTAL

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

Procedure: Perioperative dexmedetomidine infusion

Perioperative 0.9% NaCl infusion

PLACEBO COMPARATOR

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.

Procedure: Perioperative placebo infusion

Interventions

Perioperative lidocaine infusion PROCEDURE

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.

Also known as: Intravenous infusion of lidocaine solution using infusion pump.

Perioperative lidocaine infusion

Perioperative dexmedetomidine infusion PROCEDURE

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.

Also known as: Intravenous infusion of dexmedetomidine using infusion pump.

Perioperative dexmedetomidine infusion

Perioperative placebo infusion PROCEDURE

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.

Also known as: Infusion of 0.9% NaCl using infusion pump.

Perioperative 0.9% NaCl infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• known allergy to one of the investigated medications
• current chronic pain
• known chronic use of opioids, gabapentinoids and antidepressants

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care, Centre of Postgraduate Medical Education

Warsaw, 01-355, Poland

Location

MeSH Terms

Conditions

Urethral Stricture; Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Małgorzata Malec-Milewska, MD, Prof.

  Department of Anesthesia and Intensive Care, Orlowski Hospital, Warsaw

  STUDY CHAIR

Central Study Contacts

Bartosz Horosz, MD,PhD

CONTACT

0048225841122; bartosz.horosz@gmail.com

Katarzyna Białowolska-Horosz, MD,PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Perioperative infusion content known only to investigator that is responsible for infusion preparation and is not involved in patient's care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: Double blind, placebo controlled, randomized

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

PL (1)