Opioid UseSAPBNCT04258436
Serratus Anterior Plane Block for Management of Post Thoracotomy Pain
A study testing Serratus anterior block in people with Opioid Use and Post-thoracotomy Pain Syndrome, run by Indiana University at 1 site in United States.
Trial summary
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. Read more about this study
- Who is it for?
- Ages 38 weeks to 12 months
- Conditions the study is for
- Opioid Use, Post-thoracotomy Pain Syndrome, Local Anaesthetic Agent Overdose
- What is being tested?
- Serratus anterior block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 1 Jan 2021
- 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 38 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 months of age or less
- Infants undergoing cardiac surgery through a thoracotomy incision
- Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital
Who cannot join
- Infants requiring sternotomy or emergency surgery
- Allergy to local anesthetics
- Neonates less that 37 weeks gestation
- Infants intubated prior to surgery
- Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.
Read the detailed description
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management.
Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution.
Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block.
Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.
- Conditions
- Opioid Use, Post-thoracotomy Pain Syndrome, Local Anaesthetic Agent Overdose, Local Anesthetic Complication, Pain, Postoperative
- Being tested
- Serratus anterior block
- Keywords
- Post thoractomy pain, Fascial plane blocks, Early recovery after thoractomy, Serratus anterior fascial block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus anterior blockProcedure or surgery
Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Block Arm | Active comparator | Group1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia Receives: Procedure: Serratus anterior block |
| Group 2-No Block Arm | No intervention | Group 2 will not receive a serratus block after induction of general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Postoperative Narcotic Exposure
Total morphine equivalents in first 24 hours
Measured: From start of anesthesia to 24 hours postoperatively
Secondary outcomes (5)
Duration of Mechanical Ventilation
Total Time in hours and minutes of endotracheal intubation from date and time of intubation to the date and time of extubation up to 100 days
Measured: From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days
Length of Cardiovascular ICU stay
Duration of hospital stay in the Cardiovascular ICU in hours up to 100 days
Measured: From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days
Postoperative Pain Scores
Pain scores reported at arrival to ICU, and at 1, 2, 4, 6,8,10,12,and 24 hours
Measured: From arrival to ICU to 24 hours postoperatively
Duration of Supplemental oxygen exposure
Total time of supplemental oxygen usage from date and time of endotracheal extubation and application of supplemental oxygen to date and time of supplemental oxygen discontinuation up to 100 days
Measured: From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days
Adverse events
Complications from the block, anesthesia or the surgery up to 72 hours post operatively
Measured: From block placement until 72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start9 Dec 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Why it stopped: I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania K. Abbasi, Indiana University
- Investigators
- Anne E Cossu, MD, Principal investigator, Indiana University Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258436
- Sponsor's protocol ID
- 1905162549
- Acronym
- SAPB
- Status last verified
- Jun 2023
- First submitted
- 30 Aug 2019
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serratus Anterior Plane Block for Management of Post Thoracotomy Pain and Facilitation of Early Recovery After Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04258436
- Acronym / sponsor ID
- SAPB / 1905162549
- Conditions
- Opioid Use, Post-thoracotomy Pain Syndrome, Local Anaesthetic Agent Overdose, Local Anesthetic Complication, Pain, Postoperative
- Keywords
- Post thoractomy pain, Fascial plane blocks, Early recovery after thoractomy, Serratus anterior fascial block
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 6 Feb 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 is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. The hypothesis of the study is that serratus anterior plane blocks are relatively simple to perform, provide good postoperative analgesia, facilitate early tracheal extubation, and reduce the length of hospital stay after pediatric cardiac surgery through a thoracotomy.
Detailed description
This is a single-center, randomized, prospective study evaluating the effect of serratus anterior plane block performed after induction of anesthesia, but before the start of surgery on postoperative opioid requirements. There is already a postoperative protocol for the management of pain in the pediatric cardiac intensive care unit. This protocol will be maintained so all patients will be receiving clinically accepted and standard postoperative pain management.
Routine preoperative evaluation will be performed to establish eligibility for study inclusion. All patients will receive anesthesia by a pediatric cardiac anesthesiologist according to the clinical protocol established for these patients. The serratus anterior plane block will be performed by a pediatric anesthesiologist on the acute pain service team who routinely perform pain blocks at this institution.
Group 1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia. Group 2 will not receive a serratus anterior block.
Postoperative pain will be managed by a pediatric cardiac intensivist according to a standard pain protocol.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-Block Arm | Active comparator | Procedure: Serratus anterior blockGroup1 will receive an ultra-sound guided serratus anterior block after induction of general anesthesia |
| Group 2-No Block Arm | No intervention | –Group 2 will not receive a serratus block after induction of general anesthesia |
Who may qualify
- Ages
- 38 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 12 months of age or less
- Infants undergoing cardiac surgery through a thoracotomy incision
- Infants having surgery performed by a Pediatric Cardiac Surgeon at Riley Hospital
Key exclusion criteria (5 listed)
- Infants requiring sternotomy or emergency surgery
- Allergy to local anesthetics
- Neonates less that 37 weeks gestation
- Infants intubated prior to surgery
- Infection at the site of the Serratus Anterior Plane Block 6. Bleeding diathesis with increased risk of hematoma at the block site 7. Allergy to morphine 8. Active pulmonary infection
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 |
|---|---|---|
| Serratus anterior blockSerratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine | Procedure or surgery | Group 1-Block Arm |
Primary outcome
Measurement of Postoperative Narcotic Exposure
Time frame: From start of anesthesia to 24 hours postoperatively
Total morphine equivalents in first 24 hours
5 secondary outcomes
Duration of Mechanical Ventilation
Time frame: From date and time of endotracheal intubation to the date and time of endotracheal extubation up to 100 days
Length of Cardiovascular ICU stay
Time frame: From admission to the Cardiovascular ICU until discharge ready time from the Cardiovascular ICU up to 100 days
Postoperative Pain Scores
Time frame: From arrival to ICU to 24 hours postoperatively
Duration of Supplemental oxygen exposure
Time frame: From date and time arriving in the ICU to date and time of discharge from hospital up to 100 days
Adverse events
Time frame: From block placement until 72 hours post operatively
Results and safety
The study was stopped early (reason given: I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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.
Anne E Cossu, MD principal investigator
Indiana University Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serratus anterior block in people with Opioid Use and Post-thoracotomy Pain Syndrome, run by Indiana University 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Jun 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 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.
Are results available for this study?
The study was stopped early (reason given: I believe 1 patient was enrolled. The original PI left the institution and the study was not continued after her departure.). Results are not available in the source record.
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?
Measurement of Postoperative Narcotic Exposure (time frame: From start of anesthesia to 24 hours postoperatively). 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 18 Jun 2023.