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This study aims to evaluate the effect of combined duloxetine and IV Magnesium sulphate to decrease acute and chronic post mastectomy pain.
The study will be conducted in National Cancer Institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in National Cancer Institute, Cairo University.
It has been reported recently that Duloxetine improved the quality of recovery in patients subjected to hysterectomy. In this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. Magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DM group | Active Comparator | Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. |
|
| D group | Active Comparator | Patients received Duloxetine 30mg orally and 200 ml of normal saline. |
|
| Control group | Placebo Comparator | Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium sulphate and Duloxetine | Drug | Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first analgesic request | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared). | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Postoperative analgesia is composed of PCA-morphine, set to deliver 2 mg boluses on-demand without background infusion with a lockout period of 10 min and regular intravenous paracetamol, one gram every 8 h. | 48 hours postoperatively |
| Degree of pain |
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Inclusion Criteria:
Exclusion Criteria:
Female scheduled for modified radical mastectomy
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed s abdelgalil, MD | assistant professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National cancer institute | Cairo | 11769 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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|
| Duloxetine | Drug | Patients received Duloxetine 30mg orally and 200 ml of normal saline. |
|
|
| Placebo and normal saline | Drug | Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline. |
|
|
Each patient was instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 6, 8, 12, 24, 36 and 48 h postoperatively. |
| 48 hours postoperatively |
| Incidence of post-mastectomy pain syndrome | Incidence of post-mastectomy pain syndrome was determined at 8- and 12-weeks post-mastectomy. | 12 weeks postoperatively |
| Degree of patient satisfaction | The degree of patient satisfaction was assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied). | 48 hours postoperatively |
| Incidence of adverse events | Incidence of adverse events such as bradycardia, hypotension, postoperative nausea and vomiting (PONV) were recorded. | at 8 weeks postoperative and 12 weeks postoperative |
| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| D000068736 | Duloxetine Hydrochloride |
| D008274 | Magnesium |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D013876 | Thiophenes |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D019565 | Metals, Light |
| D008670 | Metals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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