Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Comparison of the Two Different Doses of Dexamethasone on Persistent Mastectomy Pain

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.

Study Overview

• Status: Unknown
• Conditions: Mastectomy, Modified Radical
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.1 mg/kg dexamethasone; 0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.	Drug: dexamethasone; 1 hour before surgery
Active Comparator: 0.2 mg/kg dexamethasone; 0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.	Drug: dexamethasone; 1 hour before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Postoperative 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Mustafa Kemal University
• Investigators: Principal Investigator: Onur Koyuncu, Assist.Prof, Mustafa Kemal University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: September 7, 2015
• First Submitted That Met QC Criteria: September 15, 2015
• First Posted (Estimate): September 16, 2015

Study Record Updates

• Last Update Posted (Estimate): September 16, 2015
• Last Update Submitted That Met QC Criteria: September 15, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Dexamethasone; mastectomy; persistent surgical pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 208