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Clinical Trials/NCT04928521
NCT04928521
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country70 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Ankara City Hospital Bilkent
Enrollment
70
Locations
1
Primary Endpoint
Post-extubation 12th hour measurement
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
October 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Eda Balci

Principal investigator

Ankara City Hospital Bilkent

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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

  • Mechanical ventilation duration(postoperative, approximately 4 to 10 hours)
  • intensive care unit duration(postoperative, approximately 12 to 36 hours)

Study Sites (1)

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