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

Phase 4

• Conditions: Breast Pain; Effect of Drugs; Anesthesia, Local
• Interventions: Drug: Placebo; Drug: Dexamethasone; Drug: Ropivacaine Injection [Naropin]

• Registration Number: NCT03700177
• Lead Sponsor: Medical University Innsbruck

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.

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Study Start: 2019-02-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine + placebo	Ropivacaine Injection [Naropin]	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%).
ropivacaine + placebo	Placebo	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%).
ropivacaine + dexamethasone	Ropivacaine Injection [Naropin]	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).
ropivacaine + dexamethasone	Dexamethasone	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).

Primary Outcome Measures

Name	Time	Method
morphine consumption in the first 72 hours	72 hours	every participants receives a morphine pump (PCA) to exactly measure opioid-consumption

Secondary Outcome Measures

Name	Time	Method
VAS-scores in the first 72 hours	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".

Trial Locations

Locations (1)

Medical University of Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria