Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, Lidocaine, Isotonic saline.
- Who it may be relevant to
- Registry conditions: Dexmedetomidine, Lidocaine, Infusion, Adjuvants. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial
Overview
This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.
Detailed description
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.
Interventions
- Drug Dexmedetomidine
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h. - Drug Lidocaine
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. - Drug Isotonic saline
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Primary outcome measures
- Incidence of the chronic pain [Time frame: 6 months postoperatively]
Secondary outcome measures (8)
- Time to the 1st rescue analgesia [Time frame: 48 hours postoperatively]
- Heart rate [Time frame: Till the end of operation (Up to 2 hours)]
- Mean arterial pressure [Time frame: Till the end of operation (Up to 2 hours)]
- Total morphine consumption [Time frame: 48 hours postoperatively]
- Degree of pain [Time frame: 12 weeks postoperatively]
- Incidence of post-mastectomy pain syndrome [Time frame: 6 months postoperatively]
- Activity level [Time frame: 12 weeks postoperatively]
- Assessment of quality of life [Time frame: 12 weeks postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06910644 · AP2411-501-087-193