SternotomyNCT05356715
Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy.
A study testing Ultrasound guided bilateral ESBP in people with Sternotomy and Postoperative Pain, run by Kasr El Aini Hospital at 2 sites in Egypt.
Trial summary
This study aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sternotomy, Postoperative Pain
- What is being tested?
- Ultrasound guided bilateral ESBP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 30 Oct 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged from 18 to 70 years old
- Adult congenital heart disease.
- patients undergoing valve replacement due to valvular heart disease
- Coronary artery bypass grafting( CABG) without great saphenous vein (GSV) harvesting.
Who cannot join
- Emergency surgeries.
- Allergy to opioids and local anesthetic
- Patients on high inotropic support ( 100 ng/ kg/ min adrenaline or noradrenaline)
- Patients with preoperative known chest disease ( pulmonary function tests showing moderate to severe restrictive or obstructive pulmonary disease
- Long cardiopulmonary bypass (CPB) time ( more than 2 hours )
- Difficult intubation (needs more than 3 attempts bu trained anesthesiologist for a successful endotracheal intubation.)
- Skin lesions or infection at site of proposed needle insertion.
- Bleeding disorders (INR >1.4 ),( platelet count <100,000/mm3 )
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo university hospitals, kasralainy
Cairo, 11559
Kasralainy
Cairo
About this study
Official title: Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. Randomized Controlled Trial
This study aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery .
Read the detailed description
On arrival to the operating room, an I.V 20 G cannula will be inserted. . and 500 ml of ringer acetate solution will be infused within 30 minutes. .A five-lead electrocardiogram, a pulse oximeter and an noninvasive blood pressure monitor will be applied. Basal readings ( HR,blood pressur) will be recorded . Then arterial cannula will be inserted in the radial artery of the non dominant hand. Sedation with Midazolam 0.02 mg/kg will be administered at the pre- anethesia room. . Induction will be done using titrated doses of propofol (1-2 mg /kg). ,atracurium 0.5 mg /kg and 200 mcg of fentanyl
- patients will be randomly assigned into two groups :
- Group A (n=110): will receive Ultrasound guided bilateral ESBP.
- Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr. Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection.
Patients in group B will be on fentanyl infusion 2 mcg /kg/hr. Blood pressure and heart rate will be recorded every 15 min until we go on CPB. An incremental dose of fentanyl bolus 50 mcg will be given when there is increase in the heart rate or the blood pressure by 20% from the baseline. If more than tow boluses needed, then the block will be considered as failed block .Then patients will go on CPB after heparinization and cannulation of the aorta and the venous system ( single venous or double venous ), after valve replacement or CABG done , weaning from the CPB , and inotropic support will start if needed . Then patient will be transferred to ICU mechanically ventilated on assisted control mode, FiO2 :0.6 , TV: 6ml /kg , RR: 12-16/min , PEEP:5. After fulfilling the criteria for extubation ( such as P/F ratio more than 200 , spontaneous tidal volume greater than 5 mL/kg, vital capacity greater than 15 mL/kg, maximum inspiratory pressure (MIP) greater than 25 cm H2O,, fully conscious patient , stable hemodynamics and accepted valves for the arterial blood gases and chest tube drains, patient will be extubated.
All patients will be observed in the postoperative period at 4, 6, 8, 12,24 hours interval and all hemodynamics will be recorded including heart rate ,blood pressure ,the need for incremental doses of narcotics, pain assessment using the Numerical rating scales (NRS), (use numbers to rate pain), and time of extubation ( the time from the arrival to the ICU until successful extubation).
- Conditions
- Sternotomy, Postoperative Pain
- Being tested
- Ultrasound guided bilateral ESBP
- Keywords
- Erector Spinae, Ultrasound, Sternotomy, Cardiac surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided bilateral ESBPProcedure or surgery
Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | ● Group A (n=110): will receive Ultrasound guided bilateral ESBP. Receives: Procedure: Ultrasound guided bilateral ESBP |
| Group B | Active comparator | ● Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr Receives: Procedure: Ultrasound guided bilateral ESBP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to extubation after cardiac surgery
Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)
Measured: 24 hours
Secondary outcomes (2)
Perioperative fentanyl consumption.
Perioperative fentanyl consumption.
Measured: 24 hours
pain scoring using the Numerical rating scales (NRS)
pain scoring using the Numerical rating scales (NRS) The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Jan 2022
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients aged from 18-70 years old, who will undergo open heart surgery procedure through sternotomy will be included in the study. Patients will be randomly allocated into one of two groups: * Group A (n=110): will receive Ultrasound guided bilateral ESBP after induction of general anesthesia. * Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr after induction of General anesthesia
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, MD, Principal investigator, Lecturer of anesthesia, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356715
- Sponsor's protocol ID
- MD-394-2021
- Status last verified
- Nov 2023
- First submitted
- 27 Apr 2022
- Last updated
- 7 Nov 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Post-operative Recovery in Cardiac Surgery With Median Sternotomy. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05356715
- Acronym / sponsor ID
- MD-394-2021
- Conditions
- Sternotomy, Postoperative Pain
- Keywords
- Erector Spinae, Ultrasound, Sternotomy, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 2 May 2022 (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 aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery .
Detailed description
On arrival to the operating room, an I.V 20 G cannula will be inserted. . and 500 ml of ringer acetate solution will be infused within 30 minutes. .A five-lead electrocardiogram, a pulse oximeter and an noninvasive blood pressure monitor will be applied. Basal readings ( HR,blood pressur) will be recorded . Then arterial cannula will be inserted in the radial artery of the non dominant hand. Sedation with Midazolam 0.02 mg/kg will be administered at the pre- anethesia room. . Induction will be done using titrated doses of propofol (1-2 mg /kg). ,atracurium 0.5 mg /kg and 200 mcg of fentanyl
- patients will be randomly assigned into two groups :
- Group A (n=110): will receive Ultrasound guided bilateral ESBP.
- Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr. Patients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection.
Patients in group B will be on fentanyl infusion 2 mcg /kg/hr. Blood pressure and heart rate will be recorded every 15 min until we go on CPB. An incremental dose of fentanyl bolus 50 mcg will be given when there is increase in the heart rate or the blood pressure by 20% from the baseline. If more than tow boluses needed, then the block will be considered as failed block .Then patients will go on CPB after heparinization and cannulation of the aorta and the venous system ( single venous or double venous ), after valve replacement or CABG done , weaning from the CPB , and inotropic support will start if needed . Then patient will be transferred to ICU mechanically ventilated on assisted control mode, FiO2 :0.6 , TV: 6ml /kg , RR: 12-16/min , PEEP:5. After fulfilling the criteria for extubation ( such as P/F ratio more than 200 , spontaneous tidal volume greater than 5 mL/kg, vital capacity greater than 15 mL/kg, maximum inspiratory pressure (MIP) greater than 25 cm H2O,, fully conscious patient , stable hemodynamics and accepted valves for the arterial blood gases and chest tube drains, patient will be extubated.
All patients will be observed in the postoperative period at 4, 6, 8, 12,24 hours interval and all hemodynamics will be recorded including heart rate ,blood pressure ,the need for incremental doses of narcotics, pain assessment using the Numerical rating scales (NRS), (use numbers to rate pain), and time of extubation ( the time from the arrival to the ICU until successful extubation).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients aged from 18-70 years old, who will undergo open heart surgery procedure through sternotomy will be included in the study. Patients will be randomly allocated into one of two groups: * Group A (n=110): will receive Ultrasound guided bilateral ESBP after induction of general anesthesia. * Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr after induction of General anesthesia
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Ultrasound guided bilateral ESBP● Group A (n=110): will receive Ultrasound guided bilateral ESBP. |
| Group B | Active comparator | Procedure: Ultrasound guided bilateral ESBP● Group B (n=110): will receive fentanyl IV infusion 2mic/kg/hr |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged from 18 to 70 years old
- Adult congenital heart disease.
- patients undergoing valve replacement due to valvular heart disease
- Coronary artery bypass grafting( CABG) without great saphenous vein (GSV) harvesting.
Key exclusion criteria (8 listed)
- Emergency surgeries.
- Allergy to opioids and local anesthetic
- Patients on high inotropic support ( 100 ng/ kg/ min adrenaline or noradrenaline)
- Patients with preoperative known chest disease ( pulmonary function tests showing moderate to severe restrictive or obstructive pulmonary disease
- Long cardiopulmonary bypass (CPB) time ( more than 2 hours )
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 |
|---|---|---|
| Ultrasound guided bilateral ESBPPatients in group A will be positioned in the lateral position , ESPB will be done under complete aseptic conditions , using , linear ultrasound probe(Philips HD11XE Ultrasound System) , to locate the ESP at the level of the fifth dorsal vertebrae , 22 G spinal needle will be used to inject 20 ml of 0.25% of bupivacaine in the ESP bilaterally, block will done by an expert anesthesiologist , who will not be included in the data collection | Procedure or surgery | Group A, Group B |
Primary outcome
Time to extubation after cardiac surgery
Time frame: 24 hours
Time to extubation after cardiac surgery (from the arrival to ICU till successful extubation)
2 secondary outcomes
Perioperative fentanyl consumption.
Time frame: 24 hours
pain scoring using the Numerical rating scales (NRS)
Time frame: 24 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 7 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Sternotomy
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Gabapentin to Reduce Opioid Use Postoperatively (GROUP) in Children
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Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
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Not yet recruitingPhase 4
Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
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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.
Khaled Sarhan, MD principal investigator
Lecturer of anesthesia, Cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided bilateral ESBP in people with Sternotomy and Postoperative Pain, run by Kasr El Aini Hospital at 2 sites in Egypt.
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 8 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Time to extubation after cardiac surgery (time frame: 24 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 7 Nov 2023.