Pain, PostoperativeSERRINTNCT03813225
Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)
A study testing Bilateral serratus Intercostal plane Block in people with Pain, Postoperative and Pain Management, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
Trial summary
Two-parallel arm, double-blind, individually randomized controlled trial. Primary endpoint: Fentanyl consumption in the first 48 postoperative hours. Secondary endpoints: Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Pain Management, Analgesia, Patient-Controlled
- What is being tested?
- Bilateral serratus Intercostal plane Block
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteColombia
- Study dates
- 15 Jan 2019to 30 Sep 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 years to 80 years
- Patient to myocardial revascularization by sternotomy
Who cannot join
- Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- Emergency surgery
- Ejection Fraction less than 35%
- Allergy to the local anesthesics.
- Allergy to opioids
- Patient in who will be technically impossible the application of the blockade
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Luz Jenny Pacheco
Floridablanca, Santander Department, 681004
luz Pacheco, Esp, 57 7 6396767 ext. 411, luzjepal@gmail.com
About this study
Official title: Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.
Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Read the detailed description
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Inclusion criteria:
- Patient between 18 years to 80 years.
- Patient to myocardial revascularization by sternotomy
Exclusion criteria:
- Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- Emergency surgery
- Ejecction Fraction less than 35%
- Allergy to the local anesthesic.
- Allergy to opioids
- Patient in who will be technically impossible the application of the blockade
Trial treatment:
Intervention: These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Control:
These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Expected sample size, enrollment and expected number of centers:
Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of 2019
Follow-up end date:
Number of centers: 1
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
- Being tested
- Bilateral serratus Intercostal plane Block
- Keywords
- Analgesia, patient- controlled, Block , Pain Postoperative
- Medical subject headings
- Pain, Postoperative, Agnosia, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral serratus Intercostal plane BlockOther
Will be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Analgesia | No intervention | These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation for handling an analgesic in cardiovascular surgery, this start in surgery with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus. |
| Serrato intercostal plane Block | Experimental | These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus Receives: Other: Bilateral serratus Intercostal plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl Consume
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
Measured: 48 hours
Secondary outcomes (6)
Pain In Rest and in motion
It will be valued the pain at rest and in motion, by means of the verbal analog scale for pain, where zero is the absence of pain and 10 is the worst pain that has had on the lives, the pain is measured from the time of extubation what we will call zero hour, and every four hours per 48 hours.
Measured: 48 hours
Nausea and vomiting
Presence of nausea and vomiting during the first 48 hours postoperative.
Measured: 48 hours.
Sedation
Assessment of sedation in the first 48 hours postoperative with the Ramsay scale .The Ramsay scale , Is a subjective scale to assess the degree of sedation of patients, values 6 levels, from 1 where the patient is anxious and agitated ,2 Awake, coperador, focused and quiet. 3. Slept with response to orders. 4. Sleepy with brief answers to the Light. 5 is patient Slept with an answer only to the pain and 6 where the patient is deep asleep without response to stimuli.
Measured: 48 hours.
hemothorax
presence of hemothorax secundary to blockage
Measured: 24 hours
seizures
presence of seizure after to blockage
Measured: 1 hour after block
Arrhythmias
presence of Arrhythmias after of blockage
Measured: 1 hour after block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start15 Jan 2019
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Cardiovascular de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- luz Pacheco, Esp, Principal investigator, Fundacion Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813225
- Sponsor's protocol ID
- fcv465
- Acronym
- SERRINT
- Status last verified
- Aug 2019
- First submitted
- 9 Jan 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.
- ClinicalTrials.gov ID
- NCT03813225
- Acronym / sponsor ID
- SERRINT / fcv465
- Keywords
- Analgesia, patient- controlled, Block , Pain Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Fundación Cardiovascular de ColombiaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 23 Jan 2019 (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.
Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Detailed description
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
Inclusion criteria:
- Patient between 18 years to 80 years.
- Patient to myocardial revascularization by sternotomy
Exclusion criteria:
- Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- Emergency surgery
- Ejecction Fraction less than 35%
- Allergy to the local anesthesic.
- Allergy to opioids
- Patient in who will be technically impossible the application of the blockade
Trial treatment:
Intervention: These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Control:
These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Expected sample size, enrollment and expected number of centers:
Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of 2019
Follow-up end date:
Number of centers: 1
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia
| Arm | Type | Receives |
|---|---|---|
| Conventional Analgesia | No intervention | –These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation for handling an analgesic in cardiovascular surgery, this start in surgery with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus. |
| Serrato intercostal plane Block | Experimental | Other: Bilateral serratus Intercostal plane BlockThese patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient between 18 years to 80 years
- Patient to myocardial revascularization by sternotomy
Key exclusion criteria (6 listed)
- Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- Emergency surgery
- Ejection Fraction less than 35%
- Allergy to the local anesthesics.
- Allergy to opioids
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 |
|---|---|---|
| Bilateral serratus Intercostal plane BlockWill be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.) | Other | Serrato intercostal plane Block |
Primary outcome
Fentanyl Consume
Time frame: 48 hours
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
6 secondary outcomes
Pain In Rest and in motion
Time frame: 48 hours
Nausea and vomiting
Time frame: 48 hours.
Sedation
Time frame: 48 hours.
hemothorax
Time frame: 24 hours
seizures
Time frame: 1 hour after block
Arrhythmias
Time frame: 1 hour after block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- 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.
luz Pacheco, Esp principal investigator
Fundacion Cardiovascular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral serratus Intercostal plane Block in people with Pain, Postoperative and Pain Management, run by Fundación Cardiovascular de Colombia at 1 site in Colombia.
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 6 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 22 Aug 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luz Pacheco, Esp (57 7 6396767 ext. 411, luzjepal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fentanyl Consume (time frame: 48 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 22 Aug 2019.