Effect of DrugsPhase 4NCT03700177
Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block
A Phase 4 study testing Dexamethasone and Ropivacaine Injection [Naropin] in people with Effect of Drugs and Breast Pain, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Effect of Drugs, Breast Pain, Anesthesia, Local
- What is being tested?
- Dexamethasone and Ropivacaine Injection [Naropin]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Feb 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Elisabeth Hoerner, DDr., +4351250483150, elisabeth.hoerner@tirol-klniken.at
Guenther Putz, AoUniv.Prof., +4351250480275, guenther.putz@i-med.ac.at
About this study
Official title: 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.
Read the 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.
- Conditions
- Effect of Drugs, Breast Pain, Anesthesia, Local
- Being tested
- Dexamethasone, Placebo, Ropivacaine Injection [Naropin]
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexabene
modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.
PlaceboDrug
Also called sodium chloride (NaCl) 0,9%
modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
Ropivacaine Injection [Naropin]Drug
Also called Naropin
30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine + dexamethasone | Active comparator | 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). Receives: Drug: Dexamethasone; Drug: Ropivacaine Injection [Naropin] |
| ropivacaine + placebo | Placebo comparator | 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%). Receives: Drug: Placebo; Drug: Ropivacaine Injection [Naropin] |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption in the first 72 hours
every participants receives a morphine pump (PCA) to exactly measure opioid-consumption
Measured: 72 hours
Secondary outcomes (1)
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".
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Feb 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl Lindner, Prof.Dr., Study director, Department of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700177
- Sponsor's protocol ID
- 12345
- Status last verified
- Mar 2020
- First submitted
- 1 Oct 2018
- Last updated
- 12 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block - a Randomized, Double-blind, Prospective Trial
- ClinicalTrials.gov ID
- NCT03700177
- Acronym / sponsor ID
- 12345
- Conditions
- Effect of Drugs, Breast Pain, Anesthesia, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine + dexamethasone | Active comparator | Drug: Dexamethasone, Drug: 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 + placebo | Placebo comparator | Drug: Placebo, Drug: 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%). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- bleeding disorders
- any known allergy to the medication
- diabetes mellitus
- any disease that leads to alterations in the corticosteroid physiology
- drug-dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Dexabenemodified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg. | Drug | ropivacaine + dexamethasone |
| PlaceboAlso: sodium chloride (NaCl) 0,9%modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%). | Drug | ropivacaine + placebo |
| Ropivacaine Injection [Naropin]Also: Naropin30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block) | Drug | ropivacaine + dexamethasone, ropivacaine + placebo |
Primary outcome
morphine consumption in the first 72 hours
Time frame: 72 hours
every participants receives a morphine pump (PCA) to exactly measure opioid-consumption
1 secondary outcome
VAS-scores in the first 72 hours
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Lindner, Prof.Dr. study director
Department of Anesthesia and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Ropivacaine Injection [Naropin] in people with Effect of Drugs and Breast Pain, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Hoerner, DDr (+43 512 504 83150, elisabeth.hoerner@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption in the first 72 hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.