AnalgesiaPhase 4NCT05676814
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
A Phase 4 study testing Pecto-intercostal Fascial Block (PIFB) and PIFB with adjuvants in people with Analgesia and Sternotomy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Analgesia, Sternotomy
- What is being tested?
- Pecto-intercostal Fascial Block (PIFB) and PIFB with adjuvants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2023to 24 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between undergoing cardiac surgery involving sternotomy
Who cannot join
- Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
- existing neurologic deficit in the chest wall;
- remaining intubated at the six hour point after block placement
- weight under 50kg
- undergoing emergency surgical procedures or urgent return to the operating room
- active endocarditis or mediastinitis
Show all 12Show fewer
- moderate to severe right ventricular function before or after cardiopulmonary bypass
- reliance on mechanical circulatory support devices, such as intra-aortic balloon pump or Impella
- reliance on extracorporeal membrane oxygenation
- localized or systemic infection
- chronic use of high dose opioid analgesics (defined as daily use greater than 30 oral morphine milligram equivalents (OMME) for over one month prior to surgery)
- those who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
Read the detailed description
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.
- Conditions
- Analgesia, Sternotomy
- Being tested
- Pecto-intercostal Fascial Block (PIFB), PIFB with adjuvants
- Keywords
- Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecto-intercostal Fascial Block (PIFB)Drug
PIFB done with bupivacaine and epinephrine
PIFB with adjuvantsDrug
PIFB with bupivacaine, epinephrine, clonidine, and dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Active comparator | Subjects in this arm receive standard of care PIFB after surgery Receives: Drug: Pecto-intercostal Fascial Block (PIFB) |
| PIFB with adjuvants | Experimental | Subjects in this arm receive standard of care PIFB with additional medications after surgery Receives: Drug: PIFB with adjuvants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
Measured: 0 to 6 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 12 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 18 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 24 hours after block placement
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 36 hours after block placement
Secondary outcomes (11)
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 6 hours after block placement
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Pain scores range from 0 to 10 with higher scores denoting more pain.
Measured: 6, 12, 18, 24 hours after block placement
Average Cumulative Opioid Consumption
Average Cumulative Opioid Consumption in milligrams
Measured: 36 hours after block placement
Average Time to First Opioid Administration
Average Time to First Opioid Administration - Postoperative after extubation measured in minutes
Measured: Up to 36 hours after block placement
Average Time to Extubation
Average Time to Extubation - measured in minutes
Measured: Up to 36 hours after block placement
Duration of Intensive Care Unit (ICU) Admission
Duration of Intensive Care Unit (ICU) Admission - measured in Average number of hours.
Measured: Up to 52 hours after block placement
Incentive Spirometry Volumes
An incentive spirometer is a handheld medical device that measures the volume of subject's breath. The volume of air displaced is indicated in milliliters on a scale located on the device enclosure. This device measures what is called vital capacity, the amount of air that is breathed in and out of the lungs.
Measured: 6, 12, 18, 24 hours after block placement
Safety Outcome: Nausea Incidence
Average number of incidences of Nausea
Measured: Up to 36 hours after block placement
Safety Outcome: Vomiting Incidence
Average number of Vomiting incidences
Measured: Up to 36 hours after block placement
Safety Outcome: Postoperative Delirium Incidence
Average number of Delirium incidences
Measured: Up to 36 hours after block placement
Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen
Patient-reported scores range from 0-10 where 0 represents completely unsatisfied and 10 represents completely satisfied.
Measured: 36 hours after block placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start24 Mar 2023
- Primary completion23 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Coleman, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676814
- Sponsor's protocol ID
- IRB00090669
- Status last verified
- Apr 2024
- First submitted
- 22 Dec 2022
- Last updated
- 11 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pecto-intercostal Fascial Block With Perineural Adjuvants for Postoperative Analgesia Following Sternotomy in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05676814
- Acronym / sponsor ID
- IRB00090669
- Conditions
- Analgesia, Sternotomy
- Keywords
- Pecto-intercostal Fascial Block, Postoperative, Pain, Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 24 Mar 2023 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Posted 11 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.
Detailed description
This will be a randomized, triple-blinded, prospective, feasibility trial. Written informed consent will be obtained from all study participants prior to randomization. Patients scheduled to undergo cardiac surgery involving sternotomy at Atrium Health Wake Forest Baptist will be screened for eligibility. These patients will be approached for enrollment by research staff either during their preoperative assessment clinic visit prior to their surgery date, or when admitted as inpatients and scheduled for surgery. Subjects chosen to participate will be randomized into one or other arm and PIFB will be performed after skin closure and before transport from the operating room to the ICU. For patients who are randomized at enrollment but later excluded due to exclusion criteria prior to block placement, their randomization assignment will be replaced at the end of the initial recruitment.
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 |
|---|---|---|
| Pecto-intercostal Fascial Block (PIFB) | Active comparator | Drug: Pecto-intercostal Fascial Block (PIFB)Subjects in this arm receive standard of care PIFB after surgery |
| PIFB with adjuvants | Experimental | Drug: PIFB with adjuvantsSubjects in this arm receive standard of care PIFB with additional medications after surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults between undergoing cardiac surgery involving sternotomy
Key exclusion criteria (12 listed)
- Patients with any contraindications to regional anesthesia, such as history of allergy to amide local anesthetics or any of the perineural adjuvants
- existing neurologic deficit in the chest wall;
- remaining intubated at the six hour point after block placement
- weight under 50kg
- undergoing emergency surgical procedures or urgent return to the operating room
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 |
|---|---|---|
| Pecto-intercostal Fascial Block (PIFB)PIFB done with bupivacaine and epinephrine | Drug | Pecto-intercostal Fascial Block (PIFB) |
| PIFB with adjuvantsPIFB with bupivacaine, epinephrine, clonidine, and dexamethasone | Drug | PIFB with adjuvants |
Primary outcome
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time frame: 0 to 6 hours after block placement
Based on patient-reported dynamic Numerical Rating Scale (NRS) pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain. 0 to 6 hrs after placement.
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time frame: 12 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time frame: 18 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time frame: 24 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores
Time frame: 36 hours after block placement
Based on patient-reported dynamic NRS pain scores with incentive spirometer (IS) use in subjects that are extubated. Pain scores range from 0 to 10 with higher scores denoting more pain.
11 secondary outcomes
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Time frame: 6 hours after block placement
Patient-reported Numerical Rating Scale (NRS) Pain Scores at Rest
Time frame: 6, 12, 18, 24 hours after block placement
Average Cumulative Opioid Consumption
Time frame: 36 hours after block placement
Average Time to First Opioid Administration
Time frame: Up to 36 hours after block placement
Average Time to Extubation
Time frame: Up to 36 hours after block placement
Duration of Intensive Care Unit (ICU) Admission
Time frame: Up to 52 hours after block placement
Incentive Spirometry Volumes
Time frame: 6, 12, 18, 24 hours after block placement
Safety Outcome: Nausea Incidence
Time frame: Up to 36 hours after block placement
Safety Outcome: Vomiting Incidence
Time frame: Up to 36 hours after block placement
Safety Outcome: Postoperative Delirium Incidence
Time frame: Up to 36 hours after block placement
Numeric Rating Scale (NRS) Satisfaction With the Analgesic Regimen
Time frame: 36 hours after block placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Scott Coleman, DO principal investigator
Wake Forest University Health Sciences
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 Pecto-intercostal Fascial Block (PIFB) and PIFB with adjuvants in people with Analgesia and Sternotomy, run by Wake Forest University Health Sciences at 1 site in United States.
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 1 inclusion and 12 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 11 Jun 2024. 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 United States. 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.
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?
Yes. Results are posted in the registry (first posted 11 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Curve (AUC) Pain Score - Based on Patient-reported Dynamic Numerical Rating Scale (NRS) Pain Scores (time frame: 0 to 6 hours after block placement). The study lists 5 primary outcomes in all. 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 11 Jun 2024.