Actively Recruiting
Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial
Led by Cairo University · Updated on 2025-04-08
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating dexmedetomidine and lidocaine infusions as additional treatments with general anesthesia to manage chronic pain after mastectomy surgery. Chronic pain following breast cancer surgery is a significant issue, especially as more patients undergo these surgeries due to increased survival rates. The study aims to compare the effects of these two drug infusions on pain control after surgery. Participants will be randomly assigned to one of three groups. One group will receive an intravenous dose of dexmedetomidine followed by a continuous infusion during surgery. Another group will receive an intravenous bolus of lidocaine followed by a continuous infusion. The third group will receive a placebo infusion of isotonic saline in the same manner. These treatments are given during the mastectomy procedure. Participants will be monitored during and after surgery for pain levels, heart rate, blood pressure, and morphine use. The main outcome is the occurrence of chronic pain six months after surgery. Additional assessments include time to first pain relief, pain severity at 12 weeks, activity level, quality of life, and the incidence of post-mastectomy pain syndrome. Monitoring continues during the operation and up to six months postoperatively to evaluate the treatments' effects and safety.
CONDITIONS
Brief Title
Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years
- Female with American Society of Anesthesiologists (ASA) physical status II
- Scheduled for mastectomy with axillary dissection due to breast cancer (including modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery)
You will not qualify if you...
- Patient refusal to participate
- Known allergy to any of the study drugs
- Hepatic or renal insufficiency
- Regular use of beta blockers
- Regular use of alpha-2 adrenergic agonists and sedatives
- Regular use of psychoactive medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 hours (duration of the operation)
Participants receive either dexmedetomidine, lidocaine, or isotonic saline infusions as part of their general anesthesia during mastectomy surgery.
1 infusion during surgery
Duration - Up to 6 months postoperatively
Participants are monitored for pain management outcomes and quality of life after surgery.
Multiple follow-up assessments up to 6 months
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
M
Mohamed E Abdel Fattah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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