Actively Recruiting
The Effect of Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome; Randomized Controlled Study
Led by Cairo University · Updated on 2026-02-24
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the added effect of Amantadine or Duloxetine when combined with Pregabalin on the development of post mastectomy pain syndrome (PMPS), a common chronic pain condition occurring after breast surgery. PMPS affects 20% to 50% of patients and is a type of chronic post-surgical pain. The study investigates how these medications might influence pain pathways and nerve excitability in patients undergoing modified radical mastectomy for breast cancer. Participants are assigned randomly to one of three groups. Two hours before surgery, one group receives Pregabalin 75 mg with a placebo tablet; another group receives Pregabalin 75 mg plus Amantadine 100 mg; and the third group receives Pregabalin 75 mg plus Duloxetine 30 mg. All treatments are continued twice daily for seven days after surgery. This double-blind study compares the effect of these treatments on pain development following mastectomy. During the study, researchers will monitor the occurrence of post mastectomy pain syndrome 12 weeks after surgery as the primary outcome. Secondary outcomes include patient quality of life, activity level, pain severity at 12 weeks, and opioid use during and after surgery. Side effects related to each medication are tracked for 48 hours post-procedure. Participants are evaluated through clinical assessments and medication monitoring over the course of the treatment and follow-up period.
CONDITIONS
Brief Title
Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 65 years
- Female patients undergoing modified radical mastectomy for breast cancer
- American Society of Anesthesiologists (ASA) Physical Status II or III
- Body mass index (BMI) between 20 and 40 kg/m2
You will not qualify if you...
- Patient refusal to participate
- Known sensitivity or contraindication to study drugs
- History of psychological disorders, chronic pain, or drug abuse
- Previous use of antidepressants, anticonvulsants, or opioids before surgery
- Severe respiratory or cardiac disorders
- Advanced liver or kidney disease
- Previous breast surgery
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.
1 visit (in-person)
Duration - 8 days
Participants receive study medications starting two hours before surgery and continue taking them twice daily for seven days after surgery.
1 preoperative visit and daily medication intake for 7 days postoperative
Duration - 12 weeks
Participants are monitored for 12 weeks after surgery to assess pain syndrome occurrence, quality of life, activity level, and side effects.
Periodic assessments during 12 weeks post-procedure
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
H
Hossam H Sayed, MSc
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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