Aortic Valve SurgeryPPMAMIAVSNCT03079830
Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
A study testing Piritramid and Saline in people with Aortic Valve Surgery and Postoperative; Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Surgery, Postoperative; Pain
- What is being tested?
- Piritramid and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSlovenia
- Study dates
- Oct 2016to 11 Jan 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients after minimally invasive aortic valve surgery
- Patients agreement with the study
Who cannot join
- Age under 18 years
- Allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
Read the detailed description
Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent.
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery.
Patients will then be randomised in two groups according to the protocol:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand
All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand.
Analgesia effectivness will be checked hourly according to the visual analogue scale (VAS). According to protocol, bolus will be given every time the score of VAS scale is >3.
The catheter will be removed 48 hours after the protocols' start.
- Conditions
- Aortic Valve Surgery, Postoperative; Pain
- Being tested
- Piritramid, Saline
- Keywords
- aortic valve surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiritramidDrug
Also called Dipidolor
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
SalineDrug
Also called Saline Solution
Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine continous infusion | Active comparator | Piritramid Receives: Drug: Piritramid |
| Saline continous | Sham comparator | Piritramid Receives: Drug: Piritramid; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
Comparison of cumulative postoperative dose of Piritramid between the two protocols
Measured: 48 hours after admission to the intensive care unit (ICU)
Secondary outcomes (5)
Complications related to the catheter in the surgical wound
Complications related to the catheter in the surgical wound
Measured: Up to 30 days
Visual analogue scale (VAS), frequency of scores higher than 3
Visual analogue scale (VAS), frequency of scores higher than 3
Measured: 48 hours after admission to the ICU
Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale
Patients satisfaction regarding pain relief, in the following order 1.very satisfied 2.satisfied 3.neither satisfied nor dissatisfied 4.dissatisfied 5.completely dissatisfied
Measured: 72 hours after surgery
Rate of complications related to the local anesthetic
Neurotoxicity and cardiotoxicity related to the local anesthetic
Measured: 72 hours after surgery
Hospital lenght of stay
Hospital lenght of stay
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study startOct 2016
- Primary completion31 Dec 2017
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve SurgeryStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Sostaric, University Medical Centre Ljubljana
- Investigators
- Maja Sostaric, PhD, Study chair, Clinical department of anesthesiology and intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079830
- Sponsor's protocol ID
- KVIT2016
- Acronym
- PPMAMIAVS
- Status last verified
- Mar 2019
- First submitted
- 11 Oct 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Mijovski G, Podbregar M, Ksela J, Jenko M, Sostaric M. Effectiveness of wound infusion of 0.2% ropivacaine by patient control analgesia pump after minithoracotomy aortic valve replacement: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):172. doi: 10.1186/s12871-020-01093-9.
PubMed 32682395
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ropivacaine Wound Infiltration for Postoperative Pain Management After Minimally Invasive Aortic Valve Surgery
- ClinicalTrials.gov ID
- NCT03079830
- Acronym / sponsor ID
- PPMAMIAVS / KVIT2016
- Conditions
- Aortic Valve Surgery, Postoperative; Pain
- Keywords
- aortic valve surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 15 Mar 2017 (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.
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery. The patients will be enrolled in two different groups according to the protocol of the local anesthetic and saline administration:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand For all patients metamizol every 12 hours plus bolous of piritramid on demand.
Detailed description
Patients undergoing minimally invasive aortic valve replacment surgery will be enroled in the study, after giving a signed informed consent.
The study evaluates the efficacy of local anesthestic application through the catheter in the surgical wound for the postoperative pain relief after minimally invasive aortic valve surgery.
Patients will then be randomised in two groups according to the protocol:
- group: continous infusion of the local anesthetic plus bolus on demand
- group: continous infusion of saline plus bolus on demand
All patients will receive Metamizol every 12 hours plus bolus of piritramid on demand.
Analgesia effectivness will be checked hourly according to the visual analogue scale (VAS). According to protocol, bolus will be given every time the score of VAS scale is >3.
The catheter will be removed 48 hours after the protocols' start.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine continous infusion | Active comparator | Drug: PiritramidPiritramid |
| Saline continous | Sham comparator | Drug: Piritramid, Drug: SalinePiritramid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients after minimally invasive aortic valve surgery
- Patients agreement with the study
Key exclusion criteria (2 listed)
- Age under 18 years
- Allergy to local anesthetic
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 |
|---|---|---|
| PiritramidAlso: DipidolorPiritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter. | Drug | Ropivacaine continous infusion, Saline continous |
| SalineAlso: Saline SolutionPiritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter. | Drug | Saline continous |
Primary outcome
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia.
Time frame: 48 hours after admission to the intensive care unit (ICU)
Comparison of cumulative postoperative dose of Piritramid between the two protocols
5 secondary outcomes
Complications related to the catheter in the surgical wound
Time frame: Up to 30 days
Visual analogue scale (VAS), frequency of scores higher than 3
Time frame: 48 hours after admission to the ICU
Patients satisfaction with pain relief measured by Likert-type Patient satisfaction scale
Time frame: 72 hours after surgery
Rate of complications related to the local anesthetic
Time frame: 72 hours after surgery
Hospital lenght of stay
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 32682395Mijovski G, Podbregar M, Ksela J, Jenko M, Sostaric M. Effectiveness of wound infusion of 0.2% ropivacaine by patient control analgesia pump after minithoracotomy aortic valve replacement: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2020 Jul 18;20(1):172. doi: 10.1186/s12871-020-01093-9.
- 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.
Maja Sostaric, PhD study chair
Clinical department of anesthesiology 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 study testing Piritramid and Saline in people with Aortic Valve Surgery and Postoperative; Pain, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Mar 2019. 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 Slovenia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of cumulative postoperative dose of Piritramid between the two different protocols, using VAS scale to determine level of analgesia. (time frame: 48 hours after admission to the intensive care unit (ICU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079830, which also lists 1 linked publication.
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 21 Mar 2019.