Clinical trial NCT04928521: Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery
Official title: Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Postoperative Pain
Keywords: erector spinae plane block
local anesthetic volume
bupivacaine
sternotomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Post-extubation 1st hour measurement
timeFrame: 1 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 1st hour measurement
timeFrame: 1 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 1st hour measurement
timeFrame: 1 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 2nd hour measurement
timeFrame: 2 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 2nd hour measurement
timeFrame: 2 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 2nd hour measurement
timeFrame: 2 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 4th hour measurement
timeFrame: 4 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 4th hour measurement
timeFrame: 4 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 4th hour measurement
timeFrame: 4 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 8th hour measurement
timeFrame: 8 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 8th hour measurement
timeFrame: 8 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 8th hour measurement
timeFrame: 8 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 12th hour measurement
timeFrame: 12 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 12th hour measurement
timeFrame: 12 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 12th hour measurement
timeFrame: 12 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 24th hour measurement
timeFrame: 24 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 24th hour measurement
timeFrame: 24 hour after endotracheal extubation, an average of 5 minutes
measure: Post-extubation 24th hour measurement
timeFrame: 24 hour after endotracheal extubation, an average of 5 minutes
Secondary outcomes:
measure: Mechanical ventilation duration
timeFrame: postoperative, approximately 4 to 10 hours
measure: intensive care unit duration
timeFrame: postoperative, approximately 12 to 36 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
state: Select State/Province
Study officials:
affiliation: Ankara City Hospital Bilkent
name: ZELİHA A DEMİR
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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. doi: 10.1097/00000542-200303000-00013.
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. doi: 10.1053/jcan.2001.24978.
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.