Clinical trial NCT03700177: Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block
Official title: Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block - a Randomized, Double-blind, Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Effect of Drugs
Breast Pain
Anesthesia, Local
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: morphine consumption in the first 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: VAS-scores in the first 72 hours
timeFrame: 72 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
state: Tirol
Study officials:
affiliation: Department of Anesthesia and Intensive Care
name: Karl Lindner, Prof.Dr.
role: STUDY_DIRECTOR
References: