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

Primary Purpose

Effect of Drugs, Breast Pain, Anesthesia, Local

Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Ropivacaine Injection [Naropin]
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Drugs

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of InnsbruckRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ropivacaine + dexamethasone

ropivacaine + placebo

Arm Description

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).

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%).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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".

Full Information

First Posted
October 1, 2018
Last Updated
March 10, 2020
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT03700177
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drugs, Breast Pain, Anesthesia, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ropivacaine + dexamethasone
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ropivacaine + placebo
Arm Type
Placebo Comparator
Arm Description
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%).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexabene
Intervention Description
modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sodium chloride (NaCl) 0,9%
Intervention Description
modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Injection [Naropin]
Other Intervention Name(s)
Naropin
Intervention Description
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
Primary Outcome Measure Information:
Title
morphine consumption in the first 72 hours
Description
every participants receives a morphine pump (PCA) to exactly measure opioid-consumption
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
VAS-scores in the first 72 hours
Description
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".
Time Frame
72 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hoerner, DDr
Phone
+43 512 504 83150
Email
elisabeth.hoerner@tirol-kliniken.at
First Name & Middle Initial & Last Name or Official Title & Degree
Guenther Putz, Prof.Dr.
Phone
+43 512 504 22400
Email
guenther.putz@tirol-kliniken.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Lindner, Prof.Dr.
Organizational Affiliation
Department of Anesthesia and Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Hoerner, DDr.
Phone
+4351250483150
Email
elisabeth.hoerner@tirol-klniken.at
First Name & Middle Initial & Last Name & Degree
Guenther Putz, AoUniv.Prof.
Phone
+4351250480275
Email
guenther.putz@i-med.ac.at

12. IPD Sharing Statement

Plan to Share IPD
No

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

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