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

Medical University Innsbruck

Status and phase: Unknown; Phase 4

Conditions: Anesthesia, Local; Effect of Drugs; Breast Pain

Treatments: Drug: Ropivacaine Injection [Naropin]; Drug: Dexamethasone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03700177

12345

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

ropivacaine + dexamethasone

Active Comparator group

Description:

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml dexamethasone (8mg).

Treatment:

Drug: Dexamethasone

Drug: Ropivacaine Injection [Naropin]

ropivacaine + placebo

Placebo Comparator group

Description:

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml placebo (NaCl 0,9%).

Treatment:

Drug: Placebo

Drug: Ropivacaine Injection [Naropin]