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in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. |
|
| Placebo | Placebo Comparator | The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 40ml of 0.25% bupivacaine | Drug |
| ||
| 40ml of 0.9% normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue pain score | The intensity of pain will be assessed by the VAS score | first 24 hours |
| Number of demands for analgesic | How many times the patient will require analgesics | First 24 hours |
| Timing of first demand for analgesic | Time lapse between recovery from surgery and first demand for analgesic | First 24 hours |
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Inclusion Criteria:
female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
Exclusion Criteria:
only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud A Alhussini, md | faculty of medicine , univeristy of alexandria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Main Univeristy Hospital | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |