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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Cardiac Surgery
• Intervention / Treatment: Procedure: bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine; Procedure: bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Select State/Province
    • Ankara, Select State/Province, Turkey, 06800
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESP block with 20 mL local anesthetic solution; An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 20 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation.	Procedure: bilateral 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; Other Names: 20 mL
Active Comparator: ESP block with 30 mL local anesthetic solution; An erector spinae plane block will be performed at the level of the 5th thoracic vertebrae with 30 mL of 0.25% bupivacaine solution under ultrasound guidance before the operation.	Procedure: bilateral 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; Other Names: 30 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-extubation 1st hour measurement	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.	1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 1st hour measurement	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.	1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 1st hour measurement	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.	1 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement	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 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement	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.	2 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 2nd hour measurement	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.	2 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement	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.	4 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement	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.	4 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 4th hour measurement	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 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement	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 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement	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.	8 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 8th hour measurement	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.	8 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement	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.	12 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement	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 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 12th hour measurement	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.	12 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement	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.	24 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement	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.	24 hour after endotracheal extubation, an average of 5 minutes
Post-extubation 24th hour measurement	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.	24 hour after endotracheal extubation, an average of 5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical ventilation duration	The total time until patients suitable for endotracheal extubation	postoperative, approximately 4 to 10 hours
intensive care unit duration	The total time until patients suitable for discharge from intensive care unit	postoperative, approximately 12 to 36 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: ZELİHA A DEMİR, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
• Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
• Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
• Cheng DC, Wall C, Djaiani G, Peragallo RA, Carroll J, Li C, Naylor D. Randomized assessment of resource use in fast-track cardiac surgery 1-year after hospital discharge. Anesthesiology. 2003 Mar;98(3):651-7.
• Silbert BS, Santamaria JD, Kelly WJ, O'brien JL, Blyth CM, Wong MY, Allen NB; Fast Track Cardiac Care Team. Early extubation after cardiac surgery: emotional status in the early postoperative period. J Cardiothorac Vasc Anesth. 2001 Aug;15(4):439-44. doi: 10.1053/jcan.2001.24978.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 26, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: bupivacaine; erector spinae plane block; sternotomy; local anesthetic volume
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: MH2.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No