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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928521
• Other study ID #: MH2.3
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara	Select State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chioléro R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mechanical ventilation duration	The total time until patients suitable for endotracheal extubation	postoperative, approximately 4 to 10 hours
Secondary	intensive care unit duration	The total time until patients suitable for discharge from intensive care unit	postoperative, approximately 12 to 36 hours