Overview

This trial is active, not recruiting.

Condition mastectomy, modified radical
Treatment dexamethasone
Phase phase 4
Sponsor Mustafa Kemal University
Start date November 2014
End date November 2015
Trial size 144 participants
Trial identifier NCT02551133, 208

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.
dexamethasone
1 hour before surgery
(Active Comparator)
0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.
dexamethasone
1 hour before surgery

Primary Outcomes

Measure
Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
time frame: Postoperative 3 months

Secondary Outcomes

Measure
Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).
time frame: Postoperative 24 hours

Eligibility Criteria

Female participants from 18 years up to 70 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Mustafa Kemal University.