NCT03700177

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Effect of Drugs
• Breast Pain
• Anesthesia, Local

Interventions

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

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-10-09
• Last updated: 2020-03-12

Locations

1 site across 1 country: Austria