Cardiac DiseaseParasternalNCT04319588
Parasternal Block for Cardiac Surgery
A study testing Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage and Infiltration with local anesthetic of access to thoracic drainage in people with Cardiac Disease and Analgesia, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Analgesia, Acute Pain
- What is being tested?
- Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage and Infiltration with local anesthetic of access to thoracic drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2020to 19 May 2020
- 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 undergoing elective cardiac surgery
- Age over 18 years
- ASA I-IV
- Approval by the patient of informed consent
Who cannot join
- Allergy to local anesthetics
- Puncture site infection
- Lack of signing of informed consent
- Weight <30 Kg
- Age <18 years
- Emergency interventions
Show all 9Show fewer
- ASA > IV
- Sternal dehiscences
- Dementia (for difficulties in managing weaning from mechanical ventilation and pain)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.
Read the detailed description
60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:
- Interventional (parasternal group)
- Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
- Conditions
- Cardiac Disease, Analgesia, Acute Pain, Postoperative Pain
- Being tested
- Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage, Infiltration with local anesthetic of access to thoracic drainage
- Medical subject headings
- Heart Diseases, Agnosia, Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainageProcedure or surgery
After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Infiltration with local anesthetic of access to thoracic drainageProcedure or surgery
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Parasternal Group | Experimental | The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia. Receives: Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage |
| Case control group | Active comparator | The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids. Receives: Procedure: Infiltration with local anesthetic of access to thoracic drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Pain Score
Postoperative pain assessment using the NRS scale (score from 0 to 10)
Measured: 24 hours
Secondary outcomes (4)
Respiratory performance at the TRI-FLOW
Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW
Measured: 24 hours
Intraoperative opioid administration
Quantitative evaluation of opioids needed in the intraoperative period
Measured: 4 hours
Total opioids consumption
Number of opioid deliveries (bolus morphine) in the postoperative period
Measured: 24 hours
Time to first opioid
The time in minutes between awakening and the first opioid administration
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start6 Mar 2020
- Primary completion9 May 2020
- Study completion19 May 2020
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 Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulia Nonnis, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319588
- Sponsor's protocol ID
- 20/20 PAR ComEt CBM
- Acronym
- Parasternal
- Status last verified
- Feb 2023
- First submitted
- 9 Mar 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
- ClinicalTrials.gov ID
- NCT04319588
- Acronym / sponsor ID
- Parasternal / 20/20 PAR ComEt CBM
- Conditions
- Cardiac Disease, Analgesia, Acute Pain, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 9 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 24 Mar 2020 (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.
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.
Detailed description
60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:
- Interventional (parasternal group)
- Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasternal Group | Experimental | Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainageThe "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia. |
| Case control group | Active comparator | Procedure: Infiltration with local anesthetic of access to thoracic drainageThe "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective cardiac surgery
- Age over 18 years
- ASA I-IV
- Approval by the patient of informed consent
Key exclusion criteria (9 listed)
- Allergy to local anesthetics
- Puncture site infection
- Lack of signing of informed consent
- Weight <30 Kg
- Age <18 years
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 |
|---|---|---|
| Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainageAfter induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention. | Procedure or surgery | Parasternal Group |
| Infiltration with local anesthetic of access to thoracic drainageInfiltration with local anesthetic of access to thoracic drainage at the end of the intervention. | Procedure or surgery | Case control group |
Primary outcome
Maximum Pain Score
Time frame: 24 hours
Postoperative pain assessment using the NRS scale (score from 0 to 10)
4 secondary outcomes
Respiratory performance at the TRI-FLOW
Time frame: 24 hours
Intraoperative opioid administration
Time frame: 4 hours
Total opioids consumption
Time frame: 24 hours
Time to first opioid
Time frame: 48 hours
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 8 Feb 2023.
- Results publication: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage and Infiltration with local anesthetic of access to thoracic drainage in people with Cardiac Disease and Analgesia, run by Campus Bio-Medico University at 1 site in Italy.
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 4 inclusion and 9 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 8 Feb 2023. 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 Italy. 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. 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?
Maximum Pain Score (time frame: 24 hours). 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 NCT04319588, 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 8 Feb 2023.