Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

NCT02551133 | Unknown Phase 4

• 1 other identifier: 208
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mastectomy, Modified Radical

Keywords

Dexamethasone; mastectomy; persistent surgical pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Acute Postsurgical Pain on visual analogue scale (VAS).

  Postoperative 24 hours

Other Outcomes (1)

• Treatment-Related Adverse Events

  Postoperative 24 hours

Study Arms (2)

0.1 mg/kg dexamethasone

ACTIVE COMPARATOR

0.1 mg/kg dexamethasone intravenous will be given 1 h before surgery.

Drug: dexamethasone

0.2 mg/kg dexamethasone

ACTIVE COMPARATOR

0.2 mg/kg dexamethasone intravenous will be given 1 h before surgery.

Drug: dexamethasone

Interventions

dexamethasone DRUG

1 hour before surgery

0.1 mg/kg dexamethasone; 0.2 mg/kg dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, female patients
• Written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Related Publications (2)

• 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.

  PMID: 19092351 BACKGROUND

• 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.

  PMID: 18682712 BACKGROUND

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Onur Koyuncu, Assist.Prof

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 16, 2015
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09