Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Mustafa Kemal University

Status and phase: Unknown; Phase 4

Conditions: Mastectomy, Modified Radical

Treatments: Drug: dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02551133

208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

0.1 mg/kg dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: dexamethasone

0.2 mg/kg dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: dexamethasone