Chronic Pain Clinical Trial
Official title:
Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain
Verified date | December 2015 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Ministry of Higher Education |
Study type | Interventional |
This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.
Status | Completed |
Enrollment | 120 |
Est. completion date | December 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 60 Years |
Eligibility |
Inclusion Criteria: - female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection Exclusion Criteria: - allergy to the study drugs - significant cardiac, respiratory, renal or hepatic disease - drug or alcohol abuse - psychiatric illness that would interfere with perception and assessment of pain |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | changes in acute pain intensity from the baseline | Visual analogue pain scale score at rest (VAS-R) and during movement or ipsilateral arm abduction (VAS-M), will be assessed at the same points score ranging from 0 to 10 (zero = no pain and 10 = the worst pain imaginable). | at 2,4,6,12,24,36 and 48 hour postoperatively | Yes |
Secondary | Postoperative adverse effects | nausea, vomiting respiratory depression, itching and sedation | 2,4,6,12,24,36 and 48 hour postoperatively. | Yes |
Secondary | The probability of developing chronic neuropathic pain | postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale | after one month and after two months postoperatively | Yes |
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