Duloxetine for Acute Post-mastectomy Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br> | Drug: Duloxetine<br>* 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.<br>|
| Active Comparator: duloxetine 30<br> | Drug: Duloxetine<br>* 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.<br>|
| Active Comparator: duloxetine 60<br> | Drug: Duloxetine<br>* 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.<br>|
| Active Comparator: duloxetine 90<br> | Drug: Duloxetine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption | 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) | 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) | 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 | 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 | vomiting is forceful discharge of stomach contents | The outcome will be obtained once 24 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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duloxetine, mastectomy, postoperative pain