Duloxetine, Magnesium Sulphate, Post-mastectomy Pain Syndrome
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGMagnesium sulphate and Duloxetine
Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.
DRUGDuloxetine
Patients received Duloxetine 30mg orally and 200 ml of normal saline.
DRUGPlacebo and normal saline
Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline.
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 65 years old. * American Society of Anesthesiologists (ASA) physical I-II * Scheduled for modified radical mastectomy (MRM) under general anesthesia.
Exclusion criteria
* Liver or kidney disease * Patient with previous chronic pain on opioids * Patients on antidepressants and antipsychotics. * Allergies to study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic request | 48 hours postoperatively | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administared). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 48 hours postoperatively | 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. |
| Degree of pain | 48 hours postoperatively | 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. |
| Incidence of post-mastectomy pain syndrome | 12 weeks postoperatively | Incidence of post-mastectomy pain syndrome was determined at 8- and 12-weeks post-mastectomy. |
| Degree of patient satisfaction | 48 hours postoperatively | 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). |
| Incidence of adverse events | at 8 weeks postoperative and 12 weeks postoperative | Incidence of adverse events such as bradycardia, hypotension, postoperative nausea and vomiting (PONV) were recorded. |
Countries
Egypt
Outcome results
None listed