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IRCT20260627069964N1 IRCT 2026-07-02 Combined Military Hospital, Rawalpindi Comparison Of Pre-Operative Administration Of Oral Duloxetine Versus Placebo For Post-Operative Pain Managament And Quality Of Recovery In Modified Radical Mastectomy Comparison Of Pre-Operative Administration Of Oral Duloxetine Versus Placebo For Post-Operative Pain Managament And Quality Of Recovery In Modified Radical Mastectomy 2026-07-01 anticipated 80 Recruiting https://irct.ir/trial/91227 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: 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. 3 MODIFIED RADICAL MASTECTOMY. Intervention 1: Intervention group: The patients in Group A will be given Tab Duloxetine 30 mg 12 hourly for 7 days before surgery. Patients non-compliant on medication in pre-operatively will be excluded from the study protocol. After the surgical procedure, patients will be kept in the high dependency unit (HDU) for observation. Intervention 2: Control group: These patients will receive placebo tablet not containing any active drug but used to ensure blinding and prevent bias. They will be given tablets as placebo in the same time intervals. Patients non-compliant on medication in pre-operatively will be excluded from the study protocol. After the surgical procedure, patients will be kept in the high dependency unit (HDU) for observation. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided
public Adnan Amjad Malik
Rawalpindi cantt
Rawalpindi Pakistan 000000 +92 333 4380864 adnanmalik1994@hotmail.com Combined Military Hospital, Rawalpindi scientific Adnan Amjad Malik
Multan Cantt
Multan Pakistan 00000 +92 333 4380864 adnanmalik1994@hotmail.com Combined Military Hospital Multan, Pakistan Pakistan Will include all ASA II and III female patients aged 18-60 years of age Patients diagnosed with non-metastatic breast cancer planned for an elective modified radical mastectomy and referred to the anesthesia clinic for pre-anesthesia assessment 18 years 60 years Female Will include patients with metastatic disease Patients already on anti-depressants or anti-psychotic treatment Patients with severe depression Patients with debilitating hypertension and/or uncontrolled diabetes. C50 Malignant neoplasm of breast Treatment - Drugs Placebo Intervention group: The patients in Group A will be given Tab Duloxetine 30 mg 12 hourly for 7 days before surgery. Patients non-compliant on medication in pre-operatively will be excluded from the study protocol. After the surgical procedure, patients will be kept in the high dependency unit (HDU) for observation. Control group: These patients will receive placebo tablet not containing any active drug but used to ensure blinding and prevent bias. They will be given tablets as placebo in the same time intervals. Patients non-compliant on medication in pre-operatively will be excluded from the study protocol. 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. Timepoint: 3,6,12 and 24 hours after the procedure. Method of measurement: 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. Combined Military Hospital, Rawalpindi Approved 2024-11-11 Combined Military Hospital Rawalpindi Rawalpindi Cantt Rawalpindi Punjab Pakistan