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NCT Number: NCT06974656

Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy

This study aims to compare the effect of intraoperative intravenous infusion of dexmedetomidine and lidocaine in the management of acute postoperative pain after mastectomy.

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Key information

Conditions

Infusion Acute Dexmedetomidine Lidocaine Modified Radical Mastectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

About this study

Postoperative pain control continues to remain suboptimal, despite multimodal analgesia regimes, minimally invasive surgical techniques, and enhanced recovery programs. Acute postoperative pain hinders patients' functional recovery and represents one of the greatest predictive factors for transition to chronic postsurgical pain.

Among adjuvants, dexmedetomidine, a highly selective α2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, seem promising for this purpose.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age from 18 to 65 years.
  • American Society of Anesthesiology (ASA) physical status II.
  • Body mass index (BMI) 18.5-35 kg/m2.
  • Scheduled for modified radical mastectomy.

Exclusion criteria

  • Patient's refusal.
  • Contraindication to the use of local anesthetics.
  • Cardiovascular disease.
  • Significant renal/hepatic impairment
  • Insulin-dependent diabetes mellitus.
  • Central nervous system or psychiatric disease.
  • Use of opioids/steroids/clonidine/other α2 agonist/analgesics or any drugs acting on the central nervous system during the previous 2 weeks.
  • Drug/alcohol abuse.
  • Inability to comprehend the pain assessment scale.

Treatment and study plan

Dexmedetomidine

Drug

Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of n 0.3-0.5 μg/kg/h.

Lidocaine

Drug

Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5-2 mg/kg/h.

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 48 hours postoperatively

    Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

Secondary outcomes

  1. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 2 hours)

    Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation.

  2. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation.

  3. Total morphine consumption

    Time frame: 48 hours postoperatively

    Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4.

  4. Degree of pain

    Time frame: 48 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 8, 12, 24, 36, and 48 h postoperatively.

  5. Incidence of adverse events

    Time frame: 48 hours postoperatively

    Incidence of adverse events such as hypotension, bradycardia, nausea, vomiting, or any other complications will be recorded.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Intraoperative Intravenous Infusion of Dexmedetomidine Versus Lidocaine in Management of Acute Postoperative Pain After Modified Radical Mastectomy: A Randomized Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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