Clinical trial NCT02551133: Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain
Official title: Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mastectomy, Modified Radical
Keywords: Dexamethasone
mastectomy
persistent surgical pain
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Persistent Surgical Pain on visual analogue scale (VAS).
timeFrame: Postoperative 3 months
Secondary outcomes:
measure: Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).
timeFrame: Postoperative 24 hours
Other outcomes:
measure: Treatment-Related Adverse Events
timeFrame: Postoperative 24 hours
Locations:
Study officials:
affiliation: Mustafa Kemal University
name: Onur Koyuncu, Assist.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
citation: Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534.