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NCT Number: NCT06910644

Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy

This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.

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Key information

Conditions

Dexmedetomidine Adjuvants Chronic Pain General Anesthesia Infusion Lidocaine Mastectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Mohammed ElSharkawy, MD

PRINCIPAL_INVESTIGATOR

Norma O Zayed, MD

PRINCIPAL_INVESTIGATOR

Samuel F Samy, MD

PRINCIPAL_INVESTIGATOR

About this study

Chronic pain after breast cancer surgery is a significant problem that is expected to become more relevant because the number of patients undergoing breast cancer surgery is increasing owing to the longer survival associated with this surgery.

Lidocaine is the local anesthetic, which is used more often, and it is considered the prototype of amino-amide local anesthetics. Dexmedetomidine (DEX) is a highly selective agonist that acts by binding with presynaptic alpha 2-adrenergic receptor and then activating the negative feedback loop of the sympathetic nerve response, leading to inhibited norepinephrine release from the sympathetic terminals and decreased reflex activity of the sympathetic nervous.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 75 years.
  • American Society of Anesthesiologists (ASA) physical status II.
  • Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.

Exclusion criteria

  • Patient refusal.
  • Known allergy to any of the study drugs.
  • Those with hepatic or renal insufficiency.
  • Patients who are running regularly on B blockers.
  • α2 adrenergic agonists and sedatives.
  • Psychoactive medications.

Treatment and study plan

Dexmedetomidine

Drug

Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 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 1.5mg/kg/h.

Isotonic saline

Drug

Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.

Primary outcomes

  1. Incidence of the chronic pain

    Time frame: 6 months postoperatively

    Incidence of the chronic pain will be recorded.

Secondary 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.

  2. Heart rate

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

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

  3. Mean arterial pressure

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

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

  4. Total morphine consumption

    Time frame: 48 hours postoperatively

    Rescue analgesia of morphine 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses will be given if the visual analogue scale (VAS)>3.

  5. Degree of pain

    Time frame: 12 weeks 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 PACU, 1, 2, 4, 6, 8, 12, 18, 24, 36, 48 h,1, 2, 3, 4, 8, and 12 weeks postoperatively.

  6. Incidence of post-mastectomy pain syndrome

    Time frame: 6 months postoperatively

    Incidence of post-mastectomy pain syndrome will be recorded.

  7. Activity level

    Time frame: 12 weeks postoperatively

    The activity level will be assessed using the Barthel Activities of Daily Living scale (ADL) 2, 3, 4, 8 and 12 weeks postoperatively. This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help .

  8. Assessment of quality of life

    Time frame: 12 weeks postoperatively

    Quality of life will be assessed using the Flanagan Quality of Life Scale (QOLS), which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patients by the pain physician, and the total score will be calculated and recorded at the preoperative assessment (baseline) and at 2, 3, 4, 8 and 12 weeks postoperatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 8, 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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