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

Study Overview
=================
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.

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

Conditions
-----------------
Effect of Drugs, Breast Pain, Anesthesia, Local

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Placebo
* Drug: Ropivacaine Injection [Naropin]


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ropivacaine + dexamethasone<br>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). | Drug: Dexamethasone<br>* modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.<br>* Other names: Dexabene;Drug: Ropivacaine Injection [Naropin]<br>* 30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)<br>* Other names: Naropin;|
| Placebo Comparator: ropivacaine + placebo<br>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%). | Drug: Placebo<br>* modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).<br>* Other names: sodium chloride (NaCl) 0,9%;Drug: Ropivacaine Injection [Naropin]<br>* 30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)<br>* Other names: Naropin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption in the first 72 hours | every participants receives a morphine pump (PCA) to exactly measure opioid-consumption | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |