Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Mastectomy, Modified Radical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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0.1 mg/kg dexamethasone

0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

1 hour before surgery

0.2 mg/kg dexamethasone

0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

1 hour before surgery

Interventions

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dexamethasone

1 hour before surgery

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No