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Trial record 30 of 3407 for:    Recruiting, Not yet recruiting, Available Studies | Pain

Duloxetine for Acute Post-mastectomy Pain

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ClinicalTrials.gov Identifier: NCT03468348
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Diab Fuad Hetta, Assiut University

Brief Summary:
The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

Condition or disease Intervention/treatment Phase
Acute Pain Drug: Duloxetine Not Applicable

Detailed Description:
patients undergoing mastectomy with axillary evacuation will be divided to four groups, Placebo group: received placebo capsule Duloxetine 30: received duloxetine 30 mg capsule Duloxetine 60: received duloxetine 60 mg capsule Duloxetine 90: received duloxetine 90 mg capsule the study medication is administered orall 2 h before surgery. Primary outcome variable: the first postoperative 24 h morphine consumption Secondary outcome: the VAS pain score measured every 4 h in the first 24 h postoperatively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : July 29, 2019
Estimated Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Placebo Comparator: placebo group Drug: Duloxetine
patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

Active Comparator: duloxetine 30 Drug: Duloxetine
patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

Active Comparator: duloxetine 60 Drug: Duloxetine
patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

Active Comparator: duloxetine 90 Drug: Duloxetine
patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.




Primary Outcome Measures :
  1. the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption [ Time Frame: the first postoperative 24 hour ]
    the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h


Secondary Outcome Measures :
  1. the intensity of pain measured by visual analogue pain scale (VAS) [ Time Frame: we will assess every 4 hour in the first postoperative 24 hour ]
    the intensity of pain measured by visual analogue pain scale (VAS) in which 0 = no pain and 10 = the maximum imaginable pain



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing mastectomy with axillary evacuation for cancer breast

Exclusion Criteria:

  • patient refusal
  • uncontrolled hypertension and ischemic heart disease
  • patients treated with chronic pain medications such as, non steroidal anti-inflammatory, pregabalin and opioids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468348


Contacts
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Contact: Diab Hetta, MD +201091090009 diabhetta25@gmail.com

Locations
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Egypt
Diab Recruiting
Assiut, Assuit, Egypt, 71515
Contact: Diab Hetta, MD    +201091090009      
Sponsors and Collaborators
Assiut University

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Responsible Party: Diab Fuad Hetta, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03468348     History of Changes
Other Study ID Numbers: SECI-IRB-IORG0006563-437
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diab Fuad Hetta, Assiut University:
duloxetine
mastectomy
postoperative pain

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents