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

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ClinicalTrials.gov Identifier: NCT03700177
Recruitment Status : Unknown
Verified March 2020 by Medical University Innsbruck.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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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.

Condition or disease Intervention/treatment Phase
Effect of Drugs Breast Pain Anesthesia, Local Drug: Dexamethasone Drug: Placebo Drug: Ropivacaine Injection [Naropin] Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block - a Randomized, Double-blind, Prospective Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Dexabene

Drug: Ropivacaine Injection [Naropin]
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
Other Name: 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: Placebo
modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
Other Name: sodium chloride (NaCl) 0,9%

Drug: Ropivacaine Injection [Naropin]
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
Other Name: Naropin


Outcome Measures
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Primary Outcome Measures :
  1. morphine consumption in the first 72 hours [ Time Frame: 72 hours ]
    every participants receives a morphine pump (PCA) to exactly measure opioid-consumption


Secondary Outcome Measures :
  1. VAS-scores in the first 72 hours [ Time Frame: 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".


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700177


Contacts
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Contact: Elisabeth Hoerner, DDr +43 512 504 83150 elisabeth.hoerner@tirol-kliniken.at
Contact: Guenther Putz, Prof.Dr. +43 512 504 22400 guenther.putz@tirol-kliniken.at

Locations
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Austria
Medical University of Innsbruck Recruiting
Innsbruck, Tirol, Austria, 6020
Contact: Elisabeth Hoerner, DDr.    +4351250483150    elisabeth.hoerner@tirol-klniken.at   
Contact: Guenther Putz, AoUniv.Prof.    +4351250480275    guenther.putz@i-med.ac.at   
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Study Director: Karl Lindner, Prof.Dr. Department of Anesthesia and Intensive Care
More Information
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03700177    
Other Study ID Numbers: 12345
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Mastodynia
Pain
Neurologic Manifestations
Dexamethasone
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents