Enhanced Recovery After Cardiac SurgeryNCT04343105
Pecto-intercostal Plane Block in On-pump Coronary Bypass Graft Surgery
A study testing pecto-intercostal plane block in people with Enhanced Recovery After Cardiac Surgery, run by Tanta University at 1 site in Egypt.
Trial summary
Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Enhanced Recovery After Cardiac Surgery
- What is being tested?
- pecto-intercostal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 1 Jul 2022
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged more than 40 years old.
- scheduled for elective open-heart surgery including CABG with on pump cardiopulmonary bypass.
Who cannot join
- Patients with severe pulmonary hypertension and / or heart failure.
- Emergency or combined cardiac surgery.
- Patients with preoperative use of intra-aortic balloon pump.
- Patients with poor ventricular function less than 45 %.
- Patients with preoperative uncontrolled arrhythmia.
- Patients with moderate to severe hepatic and / or renal dysfunction.
- Patients with anticipated difficult airway.
- Severe obstructive and / or restrictive pulmonary function test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ultrasound-guided Bilateral Single Shot Pecto -Intercostal Plane Block on Recovery After On-pump Coronary Bypass Graft Surgery
Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care This study will be conducted to evaluate the effectiveness and safety of ultrasound guided bilateral single shot pecto - intercostal plane block on recovery after on pump CABG surgery.
Read the detailed description
Fast-track anesthesia (FTA) is a procedure that enables extubation in intensive care unit (ICU) within 6 h after surgery to facilitate the recovery of consciousness and autonomous breathing. It has been safely applied to cardiac surgery since the 1990s.
FTA is feasible and safe and reduces the occurrence of ventilator induced complications, thereby decreasing ICU stay, resource use and cost.
Ultra-fast tract anesthesia (UFTA) was developed after fast-track anesthesia to further optimize the use of medical resource. With UFTA, extubation is performed immediately or within 1 h after surgery in the operating room. The benefits of UFTA include lower incidence of postoperative complications, better hemodynamic performance, shorter ICU stay.
Fast track and ultrafast track cardiac anaesthesia can be achieved by reduced opioid doses or opioid free with multimodal analgesia augmented with bilateral regional anaesthesia as pecto - intercostal plane block.
Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care.
The anteromedial chest wall (i.e., the sternum and parasternal region) is innervated by the anterior branches of the intercostal nerves. These terminal anterior branches ascend in the parasternal region through the intercostal and pectoralis major muscles to innervate the superficial tissues. They can thus be targeted in one of two fascial planes: either deep into intercostal muscles and superficial to transversus thoracis muscles or superficial to the intercostal muscles and deep into pectoralis major muscle.
The sensory innervation of the thorax is provided by the 2nd through 6th intercostal nerves. The intercostal nerves terminate in anterior cutaneous branches, which divide into medial and lateral branches, providing innervation to the anterior chest wall. A pecto - intercostal nerve block targets the anterior intercostal nerves just lateral to the sternum in the interfascial plane between pectoralis major muscle and external intercostal muscle.
- Conditions
- Enhanced Recovery After Cardiac Surgery
- Being tested
- pecto-intercostal plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pecto-intercostal plane blockProcedure or surgery
under ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles
| Study group | Role | What they receive |
|---|---|---|
| sham group | Sham comparator | will receive sham bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position Receives: Procedure: pecto-intercostal plane block |
| real group | Experimental | will receive real bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position with 10 ml bupivacaine 0.5% + 10 ml lidocaine 2% in total volume 20 ml for each side. Receives: Procedure: pecto-intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
extubation time
duration of mechanical ventilation from the end of anaesthesia till fulfillment weaning criteria and extubated
Measured: up to 7 days postoperative
Secondary outcomes (4)
Postoperative mean arterial blood pressure measurement
mean arterial blood pressure measurement in mm Hg
Measured: within 24 hours postoperative
Postoperative heart rate measurement
heart rate measurement in beat/min
Measured: within 24 hours postoperative
ICU stay duration
from admission of ICU to discharge to ward
Measured: up to 7 days postoperative
Postoperative pain measurement by numerical rating scale
Numerical Rating Scale for pain that ranged from (0 = no pain) to (10 = intolerable pain). If score is >3 will need analgesia
Measured: within 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 May 2020
- Primary completion1 Jun 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343105
- Sponsor's protocol ID
- pecto-intercostal plane block
- Status last verified
- Aug 2022
- First submitted
- 3 Apr 2020
- Last updated
- 10 Aug 2022
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound-guided Bilateral Single Shot Pecto -Intercostal Plane Block on Recovery After On-pump Coronary Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT04343105
- Acronym / sponsor ID
- pecto-intercostal plane block
- Conditions
- Enhanced Recovery After Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care This study will be conducted to evaluate the effectiveness and safety of ultrasound guided bilateral single shot pecto - intercostal plane block on recovery after on pump CABG surgery.
Detailed description
Fast-track anesthesia (FTA) is a procedure that enables extubation in intensive care unit (ICU) within 6 h after surgery to facilitate the recovery of consciousness and autonomous breathing. It has been safely applied to cardiac surgery since the 1990s.
FTA is feasible and safe and reduces the occurrence of ventilator induced complications, thereby decreasing ICU stay, resource use and cost.
Ultra-fast tract anesthesia (UFTA) was developed after fast-track anesthesia to further optimize the use of medical resource. With UFTA, extubation is performed immediately or within 1 h after surgery in the operating room. The benefits of UFTA include lower incidence of postoperative complications, better hemodynamic performance, shorter ICU stay.
Fast track and ultrafast track cardiac anaesthesia can be achieved by reduced opioid doses or opioid free with multimodal analgesia augmented with bilateral regional anaesthesia as pecto - intercostal plane block.
Fast track and ultrafast track cardiac anaesthesia appear to demonstrate improved outcomes without compromising patient safety. Their benefits include shorter intensive care unit stays, reduced duration of mechanical ventilation and lower health care costs. Regional anesthesia has played an important role in enhanced recovery pathways for other surgical services and allows for reduced systemic opioid use during intraoperative and postoperative care.
The anteromedial chest wall (i.e., the sternum and parasternal region) is innervated by the anterior branches of the intercostal nerves. These terminal anterior branches ascend in the parasternal region through the intercostal and pectoralis major muscles to innervate the superficial tissues. They can thus be targeted in one of two fascial planes: either deep into intercostal muscles and superficial to transversus thoracis muscles or superficial to the intercostal muscles and deep into pectoralis major muscle.
The sensory innervation of the thorax is provided by the 2nd through 6th intercostal nerves. The intercostal nerves terminate in anterior cutaneous branches, which divide into medial and lateral branches, providing innervation to the anterior chest wall. A pecto - intercostal nerve block targets the anterior intercostal nerves just lateral to the sternum in the interfascial plane between pectoralis major muscle and external intercostal muscle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham group | Sham comparator | Procedure: pecto-intercostal plane blockwill receive sham bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position |
| real group | Experimental | Procedure: pecto-intercostal plane blockwill receive real bilateral ultrasounded guided single shot pecto-intercostal plane block between 3rd and 4th rib 2 cm lateral to sternal border for each side after induction of anaesthesia in supine position with 10 ml bupivacaine 0.5% + 10 ml lidocaine 2% in total volume 20 ml for each side. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient aged more than 40 years old.
- scheduled for elective open-heart surgery including CABG with on pump cardiopulmonary bypass.
Key exclusion criteria (8 listed)
- Patients with severe pulmonary hypertension and / or heart failure.
- Emergency or combined cardiac surgery.
- Patients with preoperative use of intra-aortic balloon pump.
- Patients with poor ventricular function less than 45 %.
- Patients with preoperative uncontrolled arrhythmia.
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 |
|---|---|---|
| pecto-intercostal plane blockunder ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles | Procedure or surgery | real group, sham group |
Primary outcome
extubation time
Time frame: up to 7 days postoperative
duration of mechanical ventilation from the end of anaesthesia till fulfillment weaning criteria and extubated
4 secondary outcomes
Postoperative mean arterial blood pressure measurement
Time frame: within 24 hours postoperative
Postoperative heart rate measurement
Time frame: within 24 hours postoperative
ICU stay duration
Time frame: up to 7 days postoperative
Postoperative pain measurement by numerical rating scale
Time frame: within 24 hours postoperative
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 10 Aug 2022.
- Individual participant dataSharing planned: No
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Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
Not yet recruiting
Planned Operating-Room Extubation After Cardiac Surgery
Mechanical Ventilation, Cardiac Surgery
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Neonatal Enhanced Recovery After Surgery (ERAS) Outcomes Study
Neonatal Patients Undergoing Major Non-cardiac Surgery, Congenital Anomaly
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pecto-intercostal plane block in people with Enhanced Recovery After Cardiac Surgery, run by Tanta University 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 2 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 10 Aug 2022. 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. Some participants in this study may receive a placebo. 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?
extubation time (time frame: up to 7 days postoperative). 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 10 Aug 2022.