Comparison Of Pre-Operative Administration Of Oral Duloxetine Versus Placebo For Post-Operative Pain Managament And Quality Of Recovery In Modified Radical Mastectomy

our study aims to compare the patients pre-treated with oral duloxetine planned for elective modified radical mastectomy to placebo for quality of recovery, pain scores and reduced rescue analgesia requirements post-operatively.

Quasi-experimental comparative study

Department of Anesthesia, Combined Military Hospital, Rawalpindi for at least 3 months or till completion of minimum sample size

INCLUSION CRITERIA: • Will include all ASA II and III female patients aged 18-60 years of age, diagnosed with non-metastatic breast cancer planned for an elective modified radical mastectomy and referred to the anesthesia clinic for pre-anesthesia assessment EXCLUSION CRITERIA: • Will include patients with metastatic disease, already on anti-depressants or anti-psychotic treatment, patients with severe depression, patients with debilitating hypertension and/or uncontrolled diabetes.

They will be divided into Group A (n=40) to receive oral duloxetine and Group B (n=40) to receive placebo tablet not containing any active drug but used to ensure blinding and prevent bias.

After the surgical procedure, patients will be kept in the high dependency unit (HDU) for observation. Primary variable would be patient recovery assessed at 3,6,12 and 24 hours after the procedure using the QoR-40 scoring system which will include assessment of patient support, comfort, emotions, physical independence, and pain with a total score ranging from 40-200 with higher scores associated with better patient recovery. Secondary variables will be pain scores assessed using 10-point Visual Analog Scale (VAS) assessed at 3,6,12 and 24 hours post-surgery and total dose of IV Morphine used in 24 hours as rescue analgesia once pain scores will be above 6 on the VAS.

A written informed high risk consent will be taken from all patients due to nature of the surgical procedure as per standard operative guidelines. They will be divided into Group A (n=40) to receive oral duloxetine and Group B (n=40) to receive placebo tablet not containing any active drug but used to ensure blinding and prevent bias. Patients in Group A will be given Tab Duloxetine 30 mg 12 hourly for 7 days before surgery whereas patients in Group B will be given tablets as placebo in the same time intervals.

“COMPARISON OF PRE-OPERATIVE ADMINISTRATION OF ORAL DULOXETINE VERSUS PLACEBO FOR POST-OPERATIVE PAIN MANAGAMENT AND QUALITY OF RECOVERY IN MODIFIED RADICAL MASTECTOMY”

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