Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain
- Conditions
- DuloxetineMagnesium SulphatePost-mastectomy Pain Syndrome
- Interventions
- Registration Number
- NCT06087211
- Lead Sponsor
- National Cancer Institute, Egypt
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
- Age from 18 to 65 years old.
- American Society of Anesthesiologists (ASA) physical I-II
- Scheduled for modified radical mastectomy (MRM) under general anesthesia.
- Liver or kidney disease
- Patient with previous chronic pain on opioids
- Patients on antidepressants and antipsychotics.
- Allergies to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DM group Magnesium sulphate and Duloxetine Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline. D group Duloxetine Patients received Duloxetine 30mg orally and 200 ml of normal saline. Control group Placebo and normal saline Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
National cancer institute
🇪🇬Cairo, Egypt