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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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).

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 groups in NCT05356715
Study groupRoleWhat they receive
Group AExperimental● Group A (n=110): will receive Ultrasound guided bilateral ESBP.
Receives: Procedure: Ultrasound guided bilateral ESBP
Group BActive 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.

  1. 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)
  1. Perioperative fentanyl consumption.

    Perioperative fentanyl consumption.

    Measured: 24 hours

  2. 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.

  1. First posted2 May 2022
  2. Study start1 Jan 2022
  3. Primary completion30 Oct 2023
  4. Study completion30 Oct 2023

Resources

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)
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

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.

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