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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local; Effect of Drugs; Breast Pain
• Intervention / Treatment: Drug: Dexamethasone; Drug: Ropivacaine Injection [Naropin]; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Elisabeth Hoerner, DDr; Phone Number: +43 512 504 83150; Email: elisabeth.hoerner@tirol-kliniken.at
• Study Contact Backup: Name: Guenther Putz, Prof.Dr.; Phone Number: +43 512 504 22400; Email: guenther.putz@tirol-kliniken.at

Study Locations

• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Medical University of Innsbruck
      • Contact: Elisabeth Hoerner, DDr.; Phone Number: +4351250483150; Email: elisabeth.hoerner@tirol-klniken.at
      • Contact: Guenther Putz, AoUniv.Prof.; Phone Number: +4351250480275; Email: guenther.putz@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Investigators: Study Director: Karl Lindner, Prof.Dr., Department of Anesthesia and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 8, 2018
• First Posted (Actual): October 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Mastodynia; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Ropivacaine
• Other Study ID Numbers: 12345 (Danish Center for Healthcare Improvements)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No