Comparison of Duloxetine Versus Pregabalin

Comparison of Duloxetine Versus Pregabalin in Post-mastectomy Pain Syndrome: a Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Drug Effect
• Intervention / Treatment: Drug: Duloxetine; Drug: Pregablin

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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mohamed Abdel Wadod, MD; Phone Number: +201006645981; Email: m_wadod@yahoo.com
• Study Contact Backup: Name: Wala Yousef, MD; Phone Number: +201007798466; Email: wala_70s@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Nataional Cancer Instituite
    • Contact: Wala Yousef, MD; Phone Number: +201007798466; Email: wala_70s@hotmail.com
    • Contact: mohamed Abdel Wadod, MD; Phone Number: +201006645981; Email: m_wadod@yahoo.coll

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ( Group Duloxetine ); • Dosing and administration (Group A) Duloxetine 30 mg /day oral intake at bed time	Drug: Duloxetine; duloxetine
Active Comparator: (Group Pregablin ); control group Pregablin 150mg /day( 75 mg /12 hours ) oral intake.	Drug: Pregablin; Pregablin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue score	visual analogue score with least pain score is 0 and worst pain is 10	baseline till 12 weeks of treatment

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Mohamed Abdel Wadod, MD, National Cancer Institute - Cairo University - Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): April 1, 2021

Study Registration Dates

• First Submitted: December 25, 2020
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: pregabalin and Duloxetine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: AP2007-50104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No