Acute Pain Clinical Trial
Official title:
Duloxetine for Acute Post-mastectomy Pain: Placebo Controlled Dose Ranging Study
Verified date | June 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | February 10, 2020 |
Est. primary completion date | February 10, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Diab | Assiut | Assuit |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | The occurrence of vomiting | vomiting is forceful discharge of stomach contents | The outcome will be obtained once 24 hour postoperatively |
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