A Phase 4 interventional study of dexamethasone in Mastectomy, Modified Radical, sponsored by Mustafa Kemal University. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-09-16.
Sponsored by Mustafa Kemal University · Phase 4, Interventional, and Treatment
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.
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.
Mustafa Kemal University is the lead sponsor of 75 studies on the registry; 19 are open to participants now.
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0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.
Drug: dexamethasone
0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.
Drug: dexamethasone
1 hour before surgery
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.
Time frame: Postoperative 3 months
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
Time frame: Postoperative 24 hours
Treatment-Related Adverse Events
For postoperative 24 hours (0.h, 1.h, 2.h, 4.h, 8.h, 12.h, 24.h) adverse events (Bradycardia, hypertension, headache, respirator depression, cough, bronchospasm) will be evaluated. At the end of this, all of the adverse events will be assessed statistically.
Time frame: Postoperative 24 hours
No study locations are listed for this record.
The record gives a start of Nov 2014 and a primary completion of Nov 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Mustafa Kemal University