Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain
This trial is active, not recruiting.
|Condition||mastectomy, modified radical|
|Sponsor||Mustafa Kemal University|
|Start date||November 2014|
|End date||November 2015|
|Trial size||144 participants|
|Trial identifier||NCT02551133, 208|
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.
|Intervention model||parallel assignment|
|Masking||double blind (caregiver, outcomes assessor)|
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
time frame: Postoperative 3 months
Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).
time frame: Postoperative 24 hours
Female participants from 18 years up to 70 years old.
- 18-70 years old, female patients
- Written informed consent.
- 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
|Official title||Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain|
|Principal investigator||Onur Koyuncu, Assist.Prof|
|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.|
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