Erector Spinea Block in Open Heart SurgeryNCT03866733
Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery
A study testing continous erector spinea block and intravenous narcotics in people with Erector Spinea Block in Open Heart Surgery, run by Ain Shams University at 2 sites in Egypt.
Trial summary
Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Erector Spinea Block in Open Heart Surgery
- What is being tested?
- continous erector spinea block and intravenous narcotics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 18 Mar 2019to 10 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiac surgery.
- age 18-65 years.
- patients with median sternotomy.
- body mass index <30kg.m2.
- left ventricular ejection fraction >50%.
Who cannot join
- significant aortic stenosis.
- left main coronary artery disease.
- patient on anti-coagulants0
- pre-existing respiratory, neurological, or renal disease.
- CSF or blood tap during the procedure.
- failure to thread the catheter.
- anomalies of vertebral column.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Sanaa Farag Mahmoud
Cairo, New Cairo, 11835
Ainshams hospitals
Cairo, 11591
About this study
Official title: Lecturer of Anesthesia, Intensive Care and Pain Management in Ain Shams University
Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control but it has serious complications. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural. Hence, this study will compare continuous bilateral erector spinae block guided by ultrasound with intravenous analgesia which is the standard method for pain management in cardiac surgery.
Read the detailed description
Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control. in spite of its serious complications such as epidural hematoma with or without paraplegia that enhanced by heparin administered during cardiac bypass surgery..
Paravertebral blockade is comparable to Thoracic epidural analgesia in cardiac surgery but it may cause complications such as vascular injuries and pneumothorax.
Erector spinae block is recently implemented technique for treatment and analgesia of thoracic neuropathic pain and post mastectomy syndrome. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural.
This study will compare continuous bilateral erector spinae block guided by ultrasound versus intravenous analgesia for pain management in cardiac surgery Patients will be enrolled in the study will be divided into two groups In Group A: 20 patients will receive fentanyl after induction and intubation in the dose of ( 3-52mcg/kg ) according to the patients haemodynamic parameters and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU. After ICU transfer acetaminophen 1 gm/6hrs will be given regularly and NSAID if there is no contraindication after extubation. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation.
In Group B: 20 patients will have bilateral ESP block will be done under general anaesthesia bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h starting in ICU for 48 h after extubation. patients will receive intraoperative boluses of fentanyl according to the patients' haemodynamic and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation. Infusion rate will be titrated according to haemodynamics, pain assessment, and complications. After extubation acetaminophen 1gm/6hrs will be given regularly.
- Being tested
- continous erector spinea block, intravenous narcotics
- Keywords
- erector spinea block, open heart surgeries,analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continous erector spinea blockOther
Ultrasound guided erector spinea block will be performed while the patient is in left lateral position ) the US probe will be placed in longitudinal parasagittal plane lateral to the T5 spinous process. An 18-gauge epidural needle will be inserted in-plane in a cranial-to-caudal direction until the tip is deep to erector spinae muscle. A 5 cm of epidural catheter will be threaded in cephalad direction. The same steps will be performed on the other side, after the negative aspiration for blood, bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 0.1 ml/kg/h.
intravenous narcoticsDrug
Also called iv narcotics and NSAID
intervention: injection of boluses of intra venous Narcotic drugs (fentanyl) in the dose of (1-2mcg/kg) during the surgery after induction of anesthesia then fentanyl infusion through the postoperative first 24 hours postoperative till extubation then intravenous pethidine till 48 hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Narcotics group (group N) | Active comparator | intervention: injection of boluses of intra venous Narcotics (fentanyl) in the dose of (3-5 mcg/kg) during the surgery after induction of anesthesia. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till 48 hours after surgery. NSAID every 12 hrs if there is no contraindication and iv acetaminophine igm/6hrs. Receives: Drug: intravenous narcotics |
| Erector spinea block group (group B) | Experimental | intervention: after induction our intervention will be the performance of ultrasound guided bilateral continous Erector spinea block with insertion of catheters then 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation and iv acetaminophine igm/6hrs. Receives: Other: continous erector spinea block |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of perioperative analgesia
total dose of perioperative narcotics
Measured: 48 hours after surgery
Secondary outcomes (1)
extubation time
time passed between end of surgery and removal of endotracheal tube
Measured: 12 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start18 Mar 2019
- Primary completion30 Sep 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Erector Spinea Block in Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanaa Farag Mahmoud Wasfy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866733
- Sponsor's protocol ID
- R07l2019
- Status last verified
- Jan 2021
- First submitted
- 3 Mar 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fibla JJ, Molins L, Mier JM, Sierra A, Vidal G. Comparative analysis of analgesic quality in the postoperative of thoracotomy: paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2%. Eur J Cardiothorac Surg. 2008 Mar;33(3):430-4. doi: 10.1016/j.ejcts.2007.12.003. Epub 2008 Jan 16.
PubMed 18201893Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.
PubMed 24319854Hansdottir V, Philip J, Olsen MF, Eduard C, Houltz E, Ricksten SE. Thoracic epidural versus intravenous patient-controlled analgesia after cardiac surgery: a randomized controlled trial on length of hospital stay and patient-perceived quality of recovery. Anesthesiology. 2006 Jan;104(1):142-51. doi: 10.1097/00000542-200601000-00020.
PubMed 16394700Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271.
PubMed 11426357Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x.
PubMed 12688271
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Anesthesia, Intensive Care and Pain Management in Ain Shams University
- ClinicalTrials.gov ID
- NCT03866733
- Acronym / sponsor ID
- R07l2019
- Keywords
- erector spinea block, open heart surgeries,analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 7 Mar 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.
Adequate postoperative pain relief in patients in cardiac surgery is very essential. multimodal techniques for perioperative pain management post cardiac surgery include intravenous patient controlled analgesia, thoracic epidural and paravertebral blockade. Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control but it has serious complications. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural. Hence, this study will compare continuous bilateral erector spinae block guided by ultrasound with intravenous analgesia which is the standard method for pain management in cardiac surgery.
Detailed description
Analgesia through thoracic epidural is the gold standard technique for post-sternotomy pain control. in spite of its serious complications such as epidural hematoma with or without paraplegia that enhanced by heparin administered during cardiac bypass surgery..
Paravertebral blockade is comparable to Thoracic epidural analgesia in cardiac surgery but it may cause complications such as vascular injuries and pneumothorax.
Erector spinae block is recently implemented technique for treatment and analgesia of thoracic neuropathic pain and post mastectomy syndrome. ESP block is an easy technique compared to paravertebral block and less hazardous than thoracic epidural.
This study will compare continuous bilateral erector spinae block guided by ultrasound versus intravenous analgesia for pain management in cardiac surgery Patients will be enrolled in the study will be divided into two groups In Group A: 20 patients will receive fentanyl after induction and intubation in the dose of ( 3-52mcg/kg ) according to the patients haemodynamic parameters and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU. After ICU transfer acetaminophen 1 gm/6hrs will be given regularly and NSAID if there is no contraindication after extubation. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation.
In Group B: 20 patients will have bilateral ESP block will be done under general anaesthesia bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h starting in ICU for 48 h after extubation. patients will receive intraoperative boluses of fentanyl according to the patients' haemodynamic and the decision of the anaesthesia team at skin incision, before starting Cardiopulmonary bypass and again after bypass and before sternal closure. Once the surgical procedure is finished, patients will be transferred to ICU morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation. Infusion rate will be titrated according to haemodynamics, pain assessment, and complications. After extubation acetaminophen 1gm/6hrs will be given regularly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Narcotics group (group N) | Active comparator | Drug: intravenous narcoticsintervention: injection of boluses of intra venous Narcotics (fentanyl) in the dose of (3-5 mcg/kg) during the surgery after induction of anesthesia. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till 48 hours after surgery. NSAID every 12 hrs if there is no contraindication and iv acetaminophine igm/6hrs. |
| Erector spinea block group (group B) | Experimental | Other: continous erector spinea blockintervention: after induction our intervention will be the performance of ultrasound guided bilateral continous Erector spinea block with insertion of catheters then 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 8 ml/h. morphine 0.5mg/kg as rescue analgesia will be started upon arrival till extubation and iv acetaminophine igm/6hrs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- elective cardiac surgery.
- age 18-65 years.
- patients with median sternotomy.
- body mass index <30kg.m2.
- left ventricular ejection fraction >50%.
Key exclusion criteria (7 listed)
- significant aortic stenosis.
- left main coronary artery disease.
- patient on anti-coagulants0
- pre-existing respiratory, neurological, or renal disease.
- CSF or blood tap during the procedure.
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 |
|---|---|---|
| continous erector spinea blockUltrasound guided erector spinea block will be performed while the patient is in left lateral position ) the US probe will be placed in longitudinal parasagittal plane lateral to the T5 spinous process. An 18-gauge epidural needle will be inserted in-plane in a cranial-to-caudal direction until the tip is deep to erector spinae muscle. A 5 cm of epidural catheter will be threaded in cephalad direction. The same steps will be performed on the other side, after the negative aspiration for blood, bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 0.1 ml/kg/h. | Other | Erector spinea block group (group B) |
| intravenous narcoticsAlso: iv narcotics and NSAIDintervention: injection of boluses of intra venous Narcotic drugs (fentanyl) in the dose of (1-2mcg/kg) during the surgery after induction of anesthesia then fentanyl infusion through the postoperative first 24 hours postoperative till extubation then intravenous pethidine till 48 hours after surgery. | Drug | Narcotics group (group N) |
Primary outcome
effectiveness of perioperative analgesia
Time frame: 48 hours after surgery
total dose of perioperative narcotics
1 secondary outcome
extubation time
Time frame: 12 hours after end of surgery
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 15 Jan 2021.
- Background: PubMed 18201893Fibla JJ, Molins L, Mier JM, Sierra A, Vidal G. Comparative analysis of analgesic quality in the postoperative of thoracotomy: paravertebral block with bupivacaine 0.5% vs ropivacaine 0.2%. Eur J Cardiothorac Surg. 2008 Mar;33(3):430-4. doi: 10.1016/j.ejcts.2007.12.003. Epub 2008 Jan 16.
- Background: PubMed 24319854Raksamani K, Wongkornrat W, Siriboon P, Pantisawat N. Pain management after cardiac surgery: are we underestimating post sternotomy pain? J Med Assoc Thai. 2013 Jul;96(7):824-8.
- Background: PubMed 16394700Hansdottir V, Philip J, Olsen MF, Eduard C, Houltz E, Ricksten SE. Thoracic epidural versus intravenous patient-controlled analgesia after cardiac surgery: a randomized controlled trial on length of hospital stay and patient-perceived quality of recovery. Anesthesiology. 2006 Jan;104(1):142-51. doi: 10.1097/00000542-200601000-00020.
- Background: PubMed 11426357Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271.
- Background: PubMed 12688271Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continous erector spinea block and intravenous narcotics in people with Erector Spinea Block in Open Heart Surgery, run by Ain Shams University 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 5 inclusion and 7 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 15 Jan 2021. 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?
effectiveness of perioperative analgesia (time frame: 48 hours after surgery). 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 NCT03866733, which also lists 5 linked publications.
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 15 Jan 2021.