Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Phase 4

• Conditions: Mastectomy, Modified Radical
• Interventions: Drug: dexamethasone

• Registration Number: NCT02551133
• Lead Sponsor: Mustafa Kemal University

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.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-09
• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Primary Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.2 mg/kg dexamethasone	dexamethasone	0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.
0.1 mg/kg dexamethasone	dexamethasone	0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).	Postoperative 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).	Postoperative 24 hours	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