Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

Mastectomy, Modified Radical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02551133
• Other study ID #: 208
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 7, 2015
• Last updated: September 15, 2015
• Start date: November 2014

Study information

• Verified date: September 2015
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mastectomy, Modified Radical

Intervention

Drug:
• dexamethasone
1 hour before surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes