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NCT Number: NCT04928521

Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery

Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief. This study aims to investigate the optimal local anesthetic volume (20 mL versus 30 mL) with ESP block for open-heart cardiac surgery.

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Key information

Conditions

Cardiac Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara City Hospital

Ankara, Select State/Province, 06800, Turkey (Türkiye)

About this study

In cardiac surgery, the most common cause of pain during the first two days postoperatively is median sternotomy. In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively, postoperative 24 hours pain scores ranging from 5.3 to 6.5 out of 10 with deep breathing and coughing were shown. In these patients, it may increase the frequency of atelectasis due to reasons such as failure in pain control, weak coughing, and limitation of movement, and these may lead increase in morbidity and hospital stay. Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain, they are far from being ideal analgesics alone due to their side effects such as kidney damage, bleeding risk, sedation, respiratory depression, itching, nausea, and vomiting. The complications of neuraxial techniques seem to be the disadvantages of these methods. Erector spinae plane (ESP) block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries.

The Erector spinae plane (ESP) block was first described by Forero in 2016. In this block technique, a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process. The dorsal and ventral branches of the spinal nerves are blocked in this plane. However, due to individual regional anatomical differences, there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur. Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue.

This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

Exclusion criteria

  • Emergency surgeries
  • Patients with allergic reactions to anesthesia and analgesia drugs to be used
  • Patients who do not want to participate in the study voluntarily
  • Severe systemic disease (kidney, liver, pulmonary, endocrine)
  • Substance abuse history
  • History of chronic pain
  • Psychiatric problems and communication difficulties
  • Patients who need revision due to hemostasis in the postoperative period
  • Patients with severe hemodynamic instability due to infection, heavy bleeding, etc.

Treatment and study plan

bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine

Procedure

Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine

Other names: 30 mL

bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine

Procedure

Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine

Other names: 20 mL

Primary outcomes

  1. Post-extubation 1st hour measurement

    Time frame: 1 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  2. Post-extubation 1st hour measurement

    Time frame: 1 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  3. Post-extubation 1st hour measurement

    Time frame: 1 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

  4. Post-extubation 2nd hour measurement

    Time frame: 2 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  5. Post-extubation 2nd hour measurement

    Time frame: 2 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  6. Post-extubation 2nd hour measurement

    Time frame: 2 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

  7. Post-extubation 4th hour measurement

    Time frame: 4 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  8. Post-extubation 4th hour measurement

    Time frame: 4 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  9. Post-extubation 4th hour measurement

    Time frame: 4 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

  10. Post-extubation 8th hour measurement

    Time frame: 8 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  11. Post-extubation 8th hour measurement

    Time frame: 8 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  12. Post-extubation 8th hour measurement

    Time frame: 8 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

  13. Post-extubation 12th hour measurement

    Time frame: 12 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  14. Post-extubation 12th hour measurement

    Time frame: 12 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  15. Post-extubation 12th hour measurement

    Time frame: 12 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

  16. Post-extubation 24th hour measurement

    Time frame: 24 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of the visual analog pain scale, the scale has a range of 0 to 10. The scale will be shown to patients and 0 means the patient has no pain, 10 means the patient feels the most pain ever felt.

  17. Post-extubation 24th hour measurement

    Time frame: 24 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of nausea and vomiting, if they have nausea or vomiting it will be recorded as nausea positive or vomiting positive, otherwise it will be recorded as negative.

  18. Post-extubation 24th hour measurement

    Time frame: 24 hour after endotracheal extubation, an average of 5 minutes

    patients will be evaluated in terms of rescue analgesic, when patients have more than 4 visual analog score (VAS), they will be administered 1mg/kg tramadol and it will be recorded.

Secondary outcomes

  1. Mechanical ventilation duration

    Time frame: postoperative, approximately 4 to 10 hours

    The total time until patients suitable for endotracheal extubation

  2. intensive care unit duration

    Time frame: postoperative, approximately 12 to 36 hours

    The total time until patients suitable for discharge from intensive care unit

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2021
Registry last updated
Dec 28, 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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