Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.

Detailed Description
-----------------
Breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. Acute pain can contribute to the development of persistent surgical pain. Persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. The pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. Multimodal analgesic strategies are important.Glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. A recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. It is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. And also there are a lot of mechanisms more.

Official Title
-----------------
Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain

Conditions
-----------------
Mastectomy, Modified Radical

Intervention / Treatment
-----------------
* Drug: dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-70 years old, female patients Written informed consent. Exclusion Criteria: American Society of Anesthesiologists Physical Status ˂3 Any contraindication to dexamethasone Emergency or urgent procedure Obesity body mass index ≥27 kg m2 Motion sickness and vertigo patients Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.) Significant hepatic (Alanine aminotransferase or Aspartate aminotrans > 2 times normal) Renal (serum creatinine > 2 mg/dl) impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.1 mg/kg dexamethasone<br>0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery. | Drug: dexamethasone<br>* 1 hour before surgery<br>|
| Active Comparator: 0.2 mg/kg dexamethasone<br>0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery. | Drug: dexamethasone<br>* 1 hour before surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS). | At 3.month persistent surgical pain will be evaluated using (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) . The difference between these VAS scores will be evaluated statistically. | Postoperative 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS). | 0.h, 1.h, 2.h, 4.h, 8.h, 12.h, 24.h (visual analogue scale=VAS) (score ranges from O (no pain) to 10 (worst possible pain) postoperative pain will be evaluated in the acute 24 h postoperative period | Postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexamethasone, mastectomy, persistent surgical pain