Pain Relieving Potentials of Combination of Oral Duloxetine and Intravenous Magnesium Sulphate in Post Mastectomy Pain

National Cancer Institute, Egypt90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Duloxetine Magnesium Sulphate Post-mastectomy Pain Syndrome

Interventions

Magnesium sulphate and DuloxetineDRUG

Patients received Duloxetine 30mg orally and an intravenous infusion of magnesium sulphate 50mg/kg mixed with 200 ml of normal saline.

DuloxetineDRUG

Patients received Duloxetine 30mg orally and 200 ml of normal saline.

Placebo and normal salineDRUG

Patients received a placebo capsule and an intravenous infusion of 200 mL of normal saline.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

National cancer institute

Cairo, Egypt

Outcomes

Primary Outcomes

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).

Time frame: 48 hours postoperatively

Secondary Outcomes

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.

Time frame: 48 hours postoperatively

Degree of pain

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.

Time frame: 48 hours postoperatively

Incidence of post-mastectomy pain syndrome

Incidence of post-mastectomy pain syndrome was determined at 8- and 12-weeks post-mastectomy.

Time frame: 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).

Time frame: 48 hours postoperatively

Incidence of adverse events

Incidence of adverse events such as bradycardia, hypotension, postoperative nausea and vomiting (PONV) were recorded.

Time frame: at 8 weeks postoperative and 12 weeks postoperative

Data from ClinicalTrials.gov

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