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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04928521
Enrollment
70
Registered
2021-06-16
Start date
2021-06-01
Completion date
2021-10-01
Last updated
2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Postoperative Pain

Keywords

erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy

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.

Interventions

PROCEDUREbilateral erector spinae plane block with 30 mL 0.25 % bupivacaine

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

PROCEDUREbilateral erector spinae plane block with 20 mL 0.25 % bupivacaine

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post-extubation 24th hour measurement24 hour after endotracheal extubation, an average of 5 minutespatients 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.
Post-extubation 8th hour measurement8 hour after endotracheal extubation, an average of 5 minutespatients 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.
Post-extubation 12th hour measurement12 hour after endotracheal extubation, an average of 5 minutespatients 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.
Post-extubation 1st hour measurement1 hour after endotracheal extubation, an average of 5 minutespatients 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.
Post-extubation 2nd hour measurement2 hour after endotracheal extubation, an average of 5 minutespatients 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.
Post-extubation 4th hour measurement4 hour after endotracheal extubation, an average of 5 minutespatients 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.

Secondary

MeasureTime frameDescription
intensive care unit durationpostoperative, approximately 12 to 36 hoursThe total time until patients suitable for discharge from intensive care unit
Mechanical ventilation durationpostoperative, approximately 4 to 10 hoursThe total time until patients suitable for endotracheal extubation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026