Pain, ChestPIFBNCT04134637
Bilateral Pecto Intercostal Fascial Plane Block After Open Heart Surgeries
A study testing ultrasound and Bupivacaine Hydrochloride 5 MG/ML in people with Pain, Chest, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery. The authors hypothesize that bilateral PIFB can reduce pain resulting from sternotomy following open heart surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chest
- What is being tested?
- ultrasound and Bupivacaine Hydrochloride 5 MG/ML
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 1 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cardiovascular surgery for coronary artery bypass grafting or valve replacement involving median sternotomy
Who cannot join
- Patients with emergency surgeries.
- Allergy to drug used.
- Patients with prolonged Cardio-Pulmonary Bypass time (>120 min).
- Preoperative poor left ventricular function (ejection fraction <40%).
- Body Mass Index >40.
- Systemic infections or infections at site of injection.
- Prolonged ICU stay over 24 hours for different reasons i.e.re-do surgery, heart failure etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery. The authors hypothesize that bilateral PIFB can reduce pain resulting from sternotomy following open heart surgeries.
Read the detailed description
Pain following cardiac surgery is caused by many factors; sternotomy, chest wall retraction, opening of the pericardium, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma occurring during surgery.
The pain following cardiac surgery is mainly attributed to sternotomy, with its peak during the first two days after the operation. Poststernotomy pain is not well tolerated by patients and may be accompanied by adverse postoperative events including delirium, hypertension, tachycardia, arrhythmia, respiratory complications, and persistent postsurgical pain.
Commonly pain management after cardiac surgery has been achieved using opiate analgesics. However, opiates have some dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which may influence patient recovery and may delay discharge after surgery.
The pecto-intercostal fascial block (PIFB) was recently introduced by de la Torre et al for anesthesia during breast surgery. Local anesthetic is infiltrated into the interfascial plane separating pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.
The pecto-intercostal fascial plane block can cover anterior branches of the intercostal nerves from the 2nd to 6th dermatomes with a single injection bilaterally, same as the transversus thoracic muscle plane block .
anesthetic management: All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested in patients prepared for CABG.
Patient will be premedicated by intramuscular injection of 10mg morphine in the morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. General anesthesia will be induced by midazolam 2-5 mg, fentanyl (10 μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).
Trachea will be intubated, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis. An esophageal temperature probe and a Foley catheter will also be placed.
For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.
Anesthesia will be maintained by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h for continued muscle relaxation. During extracorporeal circulation, patients will receive propofol infusion at a rate of 100-200 mg/h in addition to atracurium infusion.
Before initiation of cardiopulmonary bypass (CPB), the patients will receive intravenously tranexamic acid (2 g) and heparin (300-500 units/kg body weight) to achieve an activated clotting time > 480 s. CPB will be instituted via an ascending aortic cannula and a two-stage right atrial cannula. Before, during, and after CPB (pump blood flow: 2.4 l/min/m2), mean arterial pressure will be adjusted to exceed 60 mmHg. Cardiac arrest will be induced with cold antegrade blood cardioplegia or warm intermittent antegrade crystalloid cardioplegia. Lactate-enriched Ringer's solution will be added to the CPB circuit to maintain reservoir volume when needed, and packed red blood cells will be added when hemoglobin concentration decrease to less than 7 g/dl.
After rewarming the patient to 37°C and separation from CPB, reversal of heparin by protamine sulfate (1:1), and sternal closure will be achieved.
All patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation. The postoperative analgesia protocol involves the use of intravenous morphine or morphine equivalent dose of 5to 10 mg/kg bolus as required. Criteria for administration will be signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline).
Tracheal extubation will be performed when the patient met the following criteria: awake/arousable, hemodynamically stable, no active bleeding, warm peripheries, and satisfactory arterial blood gas with an FiO2 < 0.5,pressure support on ventilator reduced to 10 Cm H2O,Positive End Expiratory Pressure 5-7 CmH2O, no electrolyte abnormalities, minimal inotropic support, or no escalation in inotropic support.
Statistical analysis Sample size was calculated using (G power version 3). Minimal sample size of patients was 31 in each group needed to get power level 0.90, alpha level 0.05 and 30% as a difference between the two groups in the morphine consumption after the intervention. To overcome problem of loss of follow up, calculated sample size was increased by 10% to reach 35 in each group.
- Conditions
- Pain, Chest
- Being tested
- ultrasound, Bupivacaine Hydrochloride 5 MG/ML
- Keywords
- pecto intercostal fascial plane block, sternotomy
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
in the PIFB group linear ultrasound (Philips clear vue350,Philips healthcare,Andover MAO1810,USA,Machine Identification number:1385,Nile medical center,service@nilemed.net) probe will be used.
Bupivacaine Hydrochloride 5 MG/MLDrug
Also called sunnypivacaine
twenty milliliters of a solution of 0.25% bupivacaine in the PIFB group
| Study group | Role | What they receive |
|---|---|---|
| PIFB group | Experimental | For carrying out PIFB bilaterally the skin on either side of the sternum will be prepared with povidone iodine solution. Then a linear ultrasound probe will be placed on the right and left sides at 2 cm from the sternal body.
A 22 gauge, 4 inch needle will be advanced until contacting the 4th costal cartilage following the lower edge of US probe, directing the tip from the bottom of the sternum and positioning the needle tip between the pectoralis major and the external intercostal muscles. Group A will receive twenty milliliters of a solution of 0.25% bupivacaine plus epinephrine (5 mcg/ml). Boluses of 5 ml are introduced to perform hydrodissection of the interfascial plane. Receives: Device: ultrasound; Drug: Bupivacaine Hydrochloride 5 MG/ML |
| control group | No intervention | the block will not be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption
in milligram
Measured: 24 hours postoperative
Secondary outcomes (28)
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 4 hours after extubation
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 8 hours after extubation
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 12 hours after extubation
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 16 hours after extubation
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 20 hours after extubation
postoperative sternal wound pain degree
Objective pain score (1:pain at rest , 2:Pain free at rest, 3:Pain free when deep breathing, but pain when coughing, 4:Pain free, even when coughing
1 (worst) to 4 (best) not summed
Measured: 24 hours after extubation
Heart rate
in beat per minute
Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
systolic blood pressure
in millimeter mercury
Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
diastolic blood pressure
in millimeter mercury
Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
peripheral oxygen saturation
in percentage by pulse oximetry
Measured: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
heart rate
in beat per minute
Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
systolic blood pressure
in millimeter mercury
Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
diastolic blood pressure
in millimeter mercury
Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
peripheral oxygen saturation
in percentage by pulse oximetry
Measured: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
incidence of Myocardial infarction
number
Measured: 1 minute after ICU admission
incidence of postoperative pericardial effusion
number
Measured: 1 minute after ICU admission
incidence of heart failure requiring inotropic support
number
Measured: 1 minute after ICU admission
incidence of atrial fibrillation
number
Measured: 1 minute after ICU admission
partial pressure of oxygen
by mmhg in arterial blood gases
Measured: 1 minute after insertion of arterial cannula
partial pressure of oxygen
by mmhg in arterial blood gases
Measured: 1 minute after extubation
partial pressure of oxygen
by mmhg in arterial blood gases
Measured: 6 hour after extubation
partial pressure of oxygen
by mmhg in arterial blood gases
Measured: 12 hour after extubation
incidence of cerebral stroke
number
Measured: 1 minute after ICU admission up to 2 days
incidence of cerebral bleeding
number
Measured: 1 minute after ICU admission up to 2 days
Gastrointestinal bleeding
number
Measured: 1 minute after ICU admission up to 2 days
blood component requirements
number
Measured: 1 minute after ICU admission up to 2 days
incidence of sternal complications.
number
Measured: 1 minute after ICU admission up to 2 days
hospital stay
in days
Measured: 1 minute after ICU admission up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Oct 2019
- Primary completion1 Nov 2020
- Study completion1 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 Pain, ChestStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
- Investigators
- Maged L Boules, MD, Study chair, Faculty of medicine, Fayoum universityMohamed A Hamed, MD, Study director, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134637
- Sponsor's protocol ID
- D178
- Acronym
- PIFB
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2019
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
PubMed 25796483Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
PubMed 21955825Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
PubMed 22156268Del Buono R, Costa F, Agro FE. Parasternal, Pecto-intercostal, Pecs, and Transverse Thoracic Muscle Plane Blocks: A Rose by Any Other Name Would Smell as Sweet. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):791-792. doi: 10.1097/AAP.0000000000000464. No abstract available.
PubMed 27776103Ohgoshi Y, Ino K, Matsukawa M. Ultrasound-guided parasternal intercostal nerve block. J Anesth. 2016 Oct;30(5):916. doi: 10.1007/s00540-016-2202-5. Epub 2016 Jun 20. No abstract available.
PubMed 27325411
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Effect of Ultrasound Guided Bilateral Pecto Intercostal Fascial Plane Block on Sternal Wound Pain After Open Heart Surgeries
- ClinicalTrials.gov ID
- NCT04134637
- Acronym / sponsor ID
- PIFB / D178
- Conditions
- Pain, Chest
- Keywords
- pecto intercostal fascial plane block, sternotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 22 Oct 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.
The objective is to test the effect of pecto intercostal fascial plane block (PIFB) as regard its impact on pain after sternotomy involved open heart surgery. The authors hypothesize that bilateral PIFB can reduce pain resulting from sternotomy following open heart surgeries.
Detailed description
Pain following cardiac surgery is caused by many factors; sternotomy, chest wall retraction, opening of the pericardium, internal mammarian artery harvesting, saphenous vein harvesting, surgical manipulation of the parietal pleura, chest tube insertion and other musculoskeletal trauma occurring during surgery.
The pain following cardiac surgery is mainly attributed to sternotomy, with its peak during the first two days after the operation. Poststernotomy pain is not well tolerated by patients and may be accompanied by adverse postoperative events including delirium, hypertension, tachycardia, arrhythmia, respiratory complications, and persistent postsurgical pain.
Commonly pain management after cardiac surgery has been achieved using opiate analgesics. However, opiates have some dose-related side-effects such as nausea, constipation, vomiting, dizziness, mental confusion and respiratory depression, which may influence patient recovery and may delay discharge after surgery.
The pecto-intercostal fascial block (PIFB) was recently introduced by de la Torre et al for anesthesia during breast surgery. Local anesthetic is infiltrated into the interfascial plane separating pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.
The pecto-intercostal fascial plane block can cover anterior branches of the intercostal nerves from the 2nd to 6th dermatomes with a single injection bilaterally, same as the transversus thoracic muscle plane block .
anesthetic management: All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, renal and kidney functions and electrolytes. Electrocardiography, chest x ray and echocardiography will be routinely done. Coronary angiography and carotid arterial duplex will be requested in patients prepared for CABG.
Patient will be premedicated by intramuscular injection of 10mg morphine in the morning of the operation. Before induction of anesthesia, a five-lead electrocardiography system will be applied to monitor heart rate, rhythm, and ST segments (leads II and V5). A pulse oximeter probe will be attached, and a peripheral venous cannula will be placed. For measurement of arterial pressure and blood sampling, a 20 G cannula will be inserted into either right or left radial artery under local anesthesia. General anesthesia will be induced by midazolam 2-5 mg, fentanyl (10 μg/kg), propofol (3-4mg/Kg), followed by atracurium (0.5 mg/kg).
Trachea will be intubated, patients will be mechanically ventilated with oxygen in air so as to achieve normocarbia. This will be confirmed by radial arterial blood gas analysis. An esophageal temperature probe and a Foley catheter will also be placed.
For drug infusion, a triple-lumen central venous catheter will be inserted via the right internal jugular vein.
Anesthesia will be maintained by inhaled Isoflurane 0.4 to 1% and atracurium infusion at a rate of 0.5 mg/kg/h for continued muscle relaxation. During extracorporeal circulation, patients will receive propofol infusion at a rate of 100-200 mg/h in addition to atracurium infusion.
Before initiation of cardiopulmonary bypass (CPB), the patients will receive intravenously tranexamic acid (2 g) and heparin (300-500 units/kg body weight) to achieve an activated clotting time > 480 s. CPB will be instituted via an ascending aortic cannula and a two-stage right atrial cannula. Before, during, and after CPB (pump blood flow: 2.4 l/min/m2), mean arterial pressure will be adjusted to exceed 60 mmHg. Cardiac arrest will be induced with cold antegrade blood cardioplegia or warm intermittent antegrade crystalloid cardioplegia. Lactate-enriched Ringer's solution will be added to the CPB circuit to maintain reservoir volume when needed, and packed red blood cells will be added when hemoglobin concentration decrease to less than 7 g/dl.
After rewarming the patient to 37°C and separation from CPB, reversal of heparin by protamine sulfate (1:1), and sternal closure will be achieved.
All patients then will be shifted to the intensive care unit (ICU) after the surgery and managed with the institution's ICU protocol for postoperative pain management and ventilation. The postoperative analgesia protocol involves the use of intravenous morphine or morphine equivalent dose of 5to 10 mg/kg bolus as required. Criteria for administration will be signs of sympathetic stimulation in the form of undue tachycardia, a rise in mean arterial pressure (rise of >20% from the baseline).
Tracheal extubation will be performed when the patient met the following criteria: awake/arousable, hemodynamically stable, no active bleeding, warm peripheries, and satisfactory arterial blood gas with an FiO2 < 0.5,pressure support on ventilator reduced to 10 Cm H2O,Positive End Expiratory Pressure 5-7 CmH2O, no electrolyte abnormalities, minimal inotropic support, or no escalation in inotropic support.
Statistical analysis Sample size was calculated using (G power version 3). Minimal sample size of patients was 31 in each group needed to get power level 0.90, alpha level 0.05 and 30% as a difference between the two groups in the morphine consumption after the intervention. To overcome problem of loss of follow up, calculated sample size was increased by 10% to reach 35 in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIFB group | Experimental | Device: ultrasound, Drug: Bupivacaine Hydrochloride 5 MG/MLFor carrying out PIFB bilaterally the skin on either side of the sternum will be prepared with povidone iodine solution. Then a linear ultrasound probe will be placed on the right and left sides at 2 cm from the sternal body. A 22 gauge, 4 inch needle will be advanced until contacting the 4th costal cartilage following the lower edge of US probe, directing the tip from the bottom of the sternum and positioning the needle tip between the pectoralis major and the external intercostal muscles. Group A will receive twenty milliliters of a solution of 0.25% bupivacaine plus epinephrine (5 mcg/ml). Boluses of 5 ml are introduced to perform hydrodissection of the interfascial plane. |
| control group | No intervention | –the block will not be given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective cardiovascular surgery for coronary artery bypass grafting or valve replacement involving median sternotomy
Key exclusion criteria (7 listed)
- Patients with emergency surgeries.
- Allergy to drug used.
- Patients with prolonged Cardio-Pulmonary Bypass time (>120 min).
- Preoperative poor left ventricular function (ejection fraction <40%).
- Body Mass Index >40.
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 |
|---|---|---|
| ultrasoundin the PIFB group linear ultrasound (Philips clear vue350,Philips healthcare,Andover MAO1810,USA,Machine Identification number:1385,Nile medical center,service@nilemed.net) probe will be used. | Device | PIFB group |
| Bupivacaine Hydrochloride 5 MG/MLAlso: sunnypivacainetwenty milliliters of a solution of 0.25% bupivacaine in the PIFB group | Drug | PIFB group |
Primary outcome
Cumulative morphine consumption
Time frame: 24 hours postoperative
in milligram
28 secondary outcomes
postoperative sternal wound pain degree
Time frame: 4 hours after extubation
postoperative sternal wound pain degree
Time frame: 8 hours after extubation
postoperative sternal wound pain degree
Time frame: 12 hours after extubation
postoperative sternal wound pain degree
Time frame: 16 hours after extubation
postoperative sternal wound pain degree
Time frame: 20 hours after extubation
postoperative sternal wound pain degree
Time frame: 24 hours after extubation
Heart rate
Time frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
systolic blood pressure
Time frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
diastolic blood pressure
Time frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
peripheral oxygen saturation
Time frame: 1 minute before induction of anesthesia, 5 minutes after induction of anesthesia then every 30 minutes for 8 times
heart rate
Time frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
systolic blood pressure
Time frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
diastolic blood pressure
Time frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
peripheral oxygen saturation
Time frame: 1 minute after admission in ICU then every 4 hours for 6 times then every 8 hours for 3 times
incidence of Myocardial infarction
Time frame: 1 minute after ICU admission
incidence of postoperative pericardial effusion
Time frame: 1 minute after ICU admission
incidence of heart failure requiring inotropic support
Time frame: 1 minute after ICU admission
incidence of atrial fibrillation
Time frame: 1 minute after ICU admission
partial pressure of oxygen
Time frame: 1 minute after insertion of arterial cannula
partial pressure of oxygen
Time frame: 1 minute after extubation
partial pressure of oxygen
Time frame: 6 hour after extubation
partial pressure of oxygen
Time frame: 12 hour after extubation
incidence of cerebral stroke
Time frame: 1 minute after ICU admission up to 2 days
incidence of cerebral bleeding
Time frame: 1 minute after ICU admission up to 2 days
Gastrointestinal bleeding
Time frame: 1 minute after ICU admission up to 2 days
blood component requirements
Time frame: 1 minute after ICU admission up to 2 days
incidence of sternal complications.
Time frame: 1 minute after ICU admission up to 2 days
hospital stay
Time frame: 1 minute after ICU admission up to 2 days
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 19 Dec 2020.
- Background: PubMed 25796483Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.
- Background: PubMed 21955825Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
- Background: PubMed 22156268Chandrakantan A, Glass PS. Multimodal therapies for postoperative nausea and vomiting, and pain. Br J Anaesth. 2011 Dec;107 Suppl 1:i27-40. doi: 10.1093/bja/aer358.
- Background: PubMed 27776103Del Buono R, Costa F, Agro FE. Parasternal, Pecto-intercostal, Pecs, and Transverse Thoracic Muscle Plane Blocks: A Rose by Any Other Name Would Smell as Sweet. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):791-792. doi: 10.1097/AAP.0000000000000464. No abstract available.
- Background: PubMed 27325411Ohgoshi Y, Ino K, Matsukawa M. Ultrasound-guided parasternal intercostal nerve block. J Anesth. 2016 Oct;30(5):916. doi: 10.1007/s00540-016-2202-5. Epub 2016 Jun 20. No abstract available.
- 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.
Maged L Boules, MD study chair
Faculty of medicine, Fayoum university
Mohamed A Hamed, MD study director
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound and Bupivacaine Hydrochloride 5 MG/ML in people with Pain, Chest, run by Fayoum University Hospital at 1 site 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 1 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 19 Dec 2020. 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 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?
Cumulative morphine consumption (time frame: 24 hours postoperative). 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 NCT04134637, 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 19 Dec 2020.