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Completed

NCT Number: NCT03866733

Continuous Erector Spinea Block Versus Intravenous Analgesia in Coronary Bypass Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sanaa Farag Mahmoud, Cairo, New Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective cardiac surgery.
  • age 18-65 years.
  • patients with median sternotomy.
  • body mass index <30kg.m2.
  • left ventricular ejection fraction >50%.

Exclusion criteria

  • 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.

Treatment and study plan

continous erector spinea block

Other

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 narcotics

Drug

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.

Other names: iv narcotics and NSAID

Primary outcomes

  1. effectiveness of perioperative analgesia

    Time frame: 48 hours after surgery

    total dose of perioperative narcotics

Secondary outcomes

  1. extubation time

    Time frame: 12 hours after end of surgery

    time passed between end of surgery and removal of endotracheal tube

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Lecturer of Anesthesia, Intensive Care and Pain Management in Ain Shams University

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 7, 2019
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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