Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block

Anesthesia, Local Clinical Trial

Official title:

Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block - a Randomized, Double-blind, Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700177
• Other study ID #: 12345
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Medical University Innsbruck
• Contact: Elisabeth Hoerner, DDr
• Phone: +43 512 504 83150
• Email: elisabeth.hoerner[@]tirol-kliniken.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To find out if dexamethasone used as adjuvant to ropivacaine, a long-lasting local anesthetic, prolongs the duration of modified pectoral nerve block in women undergoing breast surgery.

Description:

Breast surgeries are one of the most common forms of surgery conducted in hospitals, and even relatively minor interventions can be associated with significant postoperative pain. The most common surgical procedure for breast cancer is modified radical mastectomy, which means removing a generous amount of skin and the entire breast with axillary evacuation. According to the literature, up to 50% of breast surgery patients experience severe acute postoperative pain, with 10-40% breast cancer patients experiencing pain a year or more after surgery.

Poorly controlled postoperative pain has negative physiological and psychological consequences. Furthermore, effective acute pain control preserves immune function both by suppressing surgical stress response and decreasing the need for general anesthetics and opioids in the perioperative period.

The ultrasound-guided modified, pectoral nerve block is a frequently used, easy, and reliable technique to provide complete analgesia during and after breast surgery. A major limitation to its use for postoperative analgesia is that the analgesic effect lasts only a few hours, after which moderate to severe pain at the surgical site may result in the need for alternative analgesic therapy. Several adjuvants have been used to prolong the analgesic duration of peripheral nerve block, including perineural/interfascial or intravenous dexamethasone.

Our aim is to explore the efficacy of 8 mg dexamethasone added to US-guided modified pectoral nerve block on postoperative pain in patients undergoing major breast surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• female gender

• a American Society of Anesthesiologists (ASA) score of 1 or 2

• weight: body mass index (BMI) 18 - 35 kg/m2

• informed consent

• elective, unilaterale breast surgery

Exclusion Criteria:

• bleeding disorders

• any known allergy to the medication

• diabetes mellitus

• any disease that leads to alterations in the corticosteroid physiology

• drug-dependency

• BMI <18 or > 35

• systemic infections

• psychiatric diseases, that are associated with an alteration in the perception of pain

• tumor spread at the site of injection

• inflammation at the site of injection

• pregnancy

Related Conditions & MeSH terms

• Anesthesia, Local
• Breast Pain
• Effect of Drugs
• Mastodynia

Intervention

Drug:
• Dexamethasone
modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.
• Placebo
modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
• Ropivacaine Injection [Naropin]
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck	Tirol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morphine consumption in the first 72 hours	every participants receives a morphine pump (PCA) to exactly measure opioid-consumption	72 hours
Secondary	VAS-scores in the first 72 hours	Every participant is being repeatedly asked to score pain intensity on the visual-analog scale (VAS). This is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points (0-10). VAS is the most common scale for pain quantification worldwide. A VAS-scale of 0 indicates "no pain" and 10 indicates "worst pain imaginable".	72 hours