Mirtazapine for Acute and Chronic Post Mastectomy Pain

The Effect of Peri-operative Mirtazapine on Acute and Chronic Post Mastectomy Pain (Prospective Randomized Controlled Study)

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06499090

Enrollment

Registered

2024-07-12

Start date

2024-03-01

Completion date

2025-12-20

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

Our aim in this study will be to investigate the effect of mirtazapine on acute post-mastectomy pain manifested by total morphine consumption in first 24 hours and VAS score at rest and movement (primary outcomes). chronic neuropathic pain using LANSS Pain Scale (Leeds Assessment of Neuropathic Signs and Symptoms) and to evaluate the quality of recovery using the quality of recovery-40scoring system(QoR-40) (secondary outcomes) following modified radical mastectomy for breast cancer.

Interventions

DRUGMirtazapine 30 MG

patients will receive orally the night before surgery the study medication and daily up to two weeks after Mirtazapine 30 mg tablet

DRUGPlacebo

patients will receive orally the night before surgery the study medication and daily up to two weeks after placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

female patients aged 20-70 years scheduled for modified radical mastectomy with axillary dissection for breast carcinoma

Exclusion criteria

* known allergy to the study drugs significant organ dysfunction drug or alcohol abuse epilepsy patients with chronic pain or regularly receiving analgesics any psychiatric illness that would interfere with the perception and the assessment of pain

Design outcomes

Primary

Measure	Time frame
The cumulative postoperative 24 h morphine consumption	24 hours

Secondary

Measure	Time frame	Description
The quality of recovery-40 questionnaire	24 hours	1 means very poor recover and 40 very good recovery
Assessment of sedation level	24 hours	Assessment of sedation level by the Modiﬁed Ramsay Sedation score
The visual analogue score of pain intensity	24 hours	VAS score of pain intensity at rest and arm movement (abduction of the arm of the operated side up to 90°) measured at (0, 2,4,8,12,16 and 24h) postoperatively.
Assessment of chronic pain	6 months	Assessment of chronic pain will be done after the first, third and Sixth month post-operatively by LANSS to evaluate chronic pain in the Pain Clinic.
Depression score	6 months	Depression score by the Patient Health Questionnaire(PHQ9)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026