Duloxetine for Acute Post-mastectomy Pain

June 22, 2020 updated by: Diab Fuad Hetta, Assiut University

Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assuit
      • Assiut, Assuit, Egypt, 71515
        • Diab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
  • American Society of Anesthesiologists physical status (ASA) class I and II

Exclusion Criteria:

  • Patients with a known allergy to Duloxetine or morphine,
  • A history of drug or alcohol abuse,
  • Patients with impaired kidney or liver functions,
  • Patients with chronic pain or regularly receiving analgesics,
  • Any psychiatric illness that would interfere with the perception and the assessment of pain.
  • Any reason that resulted in the protocol violation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
the first postoperative 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The intensity of pain measured by visual analogue pain scale (VAS)
Time Frame: The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
The intensity of pain measured by visual analogue pain scale (VAS) in which 0 = no pain and 10 = the maximum imaginable pain
The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.
The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)
Time Frame: the questionnair will be assessed once, 24 hour postoperatively
It measures five components of patient recovery: physical comfort (12 questions), physical independence (5 questions), emotional state (9 questions), psychological support (7 questions), and pain (7 questions). The sum of each component generates an aggregate score that ranges from 40 (i.e., extremely poor quality of recovery) to 200 (i.e., excellent quality of recovery)
the questionnair will be assessed once, 24 hour postoperatively
The level of consciousness assessed by "the Modified Ramsay Sedation score"
Time Frame: the score will be measured at 8 hour, 16 hour and 24 hour postoperatively
awake levels were: I = anxious, agitated, or restless; II = cooperative, oriented, and tranquil; III = responds to command, and asleep levels were dependent on patient's response to a light glabellar tap or loud auditory stimulus; IV= brisk response; V = a sluggish response; and VI = no response)
the score will be measured at 8 hour, 16 hour and 24 hour postoperatively
The occurrence of vomiting
Time Frame: The outcome will be obtained once 24 hour postoperatively
vomiting is forceful discharge of stomach contents
The outcome will be obtained once 24 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

February 10, 2020

Study Completion (ACTUAL)

February 10, 2020

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 11, 2018

First Posted (ACTUAL)

March 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2020

Last Update Submitted That Met QC Criteria

June 22, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECI-IRB-IORG0006563-437

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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