Acute Pain
Conditions
Keywords
duloxetine, mastectomy, postoperative pain
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.
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.
Interventions
DRUGDuloxetine
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.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| The intensity of pain measured by visual analogue pain scale (VAS) | 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 quality of postoperative recovery, assessed by The QoR-40 questionnaire (the quality of recovery-40 questionnaire) | 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 level of consciousness assessed by the Modified Ramsay Sedation score | 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 occurrence of vomiting | The outcome will be obtained once 24 hour postoperatively | vomiting is forceful discharge of stomach contents |
Countries
Egypt
Outcome results
None listed