Drug Effect
Conditions
Keywords
pregabalin and Duloxetine
Brief summary
Chronic post mastectomy pain syndrome (PMPS) is a chronic post-surgical neuropathic pain following breast cancer surgeries and lasting more than three months after surgeries. Pregabalin is originally used as an antiepileptic drug and identified as treatment for neuropathic pain .There are several recent reviews have revealed that it reduces post-operative opioid consumption and improves pain scores after breast surgeries. Duloxetine is a serotonin and norepinephrine reuptake inhibitor. Its mechanism of action is related to the potentiation of serotonergic and noradrenergic activity in the descending inhibitory pain pathways of the central nervous system and used for treatment of neuropathic pain conditions as painful diabetic neuropathy, neuropathic pain of lung cancer and chemotherapy induced sensory neuropathy
Detailed description
Patients with of 3 months of chronic neuropathic pain after breast surgery (either modified radical mastectomy or conservative breast surgery) combined with axillary dissection is considered as post mastectomy pain syndrome which is defined as pain involving the anterior aspect of the chest, axilla, and/or upper arm with the classical features of neuropathic pain including numbness, tingling, burning, shooting, stinging, or stabbing pains, and hyperesthesia. * They are divided to 2 equal groups: ( Group A) receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks . * Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours ) * Randomization and blinding: Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope. * Concomitant therapy :opioid therapy according to WHO step ladder in cancer pain
Interventions
DRUGDuloxetine
duloxetine
DRUGPregablin
Pregablin
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Randomization is done using computer generated sequence. Concealment will be achieved by opaque envelope.
Intervention model description
2 equal groups ( Group A) :receive duloxetine for 12 weeks and (Group B) control group receive pregabalin for 12 weeks . • Dosing and administration Group A) Duloxetine 30 mg /day at bed time and (Group B) control group Pregablin 150mg /day( 75 mg /12 hours
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Female, history of breast surgery and patients with post mastectomy pain
Exclusion criteria
* pregnancy,history of allergy to Pregabalin or duloxetine, pregnancy or lactation, history of pregabalin or gabapentin intake in the preceding three months, history of radiotherapy and history of drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analogue score | baseline till 12 weeks of treatment | visual analogue score with least pain score is 0 and worst pain is 10 |
Countries
Egypt
Contacts
Primary ContactMohamed Abdel Wadod, MD
Backup ContactWala yousef, Md
Outcome results
None listed