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

Primary Purpose

Cardiac Surgery, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine
bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Surgery focused on measuring erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP block with 20 mL local anesthetic solution

ESP block with 30 mL local anesthetic solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Mechanical ventilation duration
The total time until patients suitable for endotracheal extubation
intensive care unit duration
The total time until patients suitable for discharge from intensive care unit

Full Information

First Posted
June 6, 2021
Last Updated
December 26, 2021
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04928521
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Postoperative Pain
Keywords
erector spinae plane block, local anesthetic volume, bupivacaine, sternotomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP block with 20 mL local anesthetic solution
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ESP block with 30 mL local anesthetic solution
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine
Other Intervention Name(s)
30 mL
Intervention Description
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
Intervention Type
Procedure
Intervention Name(s)
bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
Other Intervention Name(s)
20 mL
Intervention Description
Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine
Primary Outcome Measure Information:
Title
Post-extubation 1st hour measurement
Description
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.
Time Frame
1 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 1st hour measurement
Description
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.
Time Frame
1 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 1st hour measurement
Description
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.
Time Frame
1 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 2nd hour measurement
Description
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.
Time Frame
2 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 2nd hour measurement
Description
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.
Time Frame
2 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 2nd hour measurement
Description
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.
Time Frame
2 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 4th hour measurement
Description
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.
Time Frame
4 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 4th hour measurement
Description
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.
Time Frame
4 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 4th hour measurement
Description
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.
Time Frame
4 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 8th hour measurement
Description
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.
Time Frame
8 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 8th hour measurement
Description
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.
Time Frame
8 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 8th hour measurement
Description
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.
Time Frame
8 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 12th hour measurement
Description
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.
Time Frame
12 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 12th hour measurement
Description
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.
Time Frame
12 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 12th hour measurement
Description
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.
Time Frame
12 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 24th hour measurement
Description
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.
Time Frame
24 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 24th hour measurement
Description
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.
Time Frame
24 hour after endotracheal extubation, an average of 5 minutes
Title
Post-extubation 24th hour measurement
Description
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.
Time Frame
24 hour after endotracheal extubation, an average of 5 minutes
Secondary Outcome Measure Information:
Title
Mechanical ventilation duration
Description
The total time until patients suitable for endotracheal extubation
Time Frame
postoperative, approximately 4 to 10 hours
Title
intensive care unit duration
Description
The total time until patients suitable for discharge from intensive care unit
Time Frame
postoperative, approximately 12 to 36 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZELİHA A DEMİR
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
State/Province
Select State/Province
ZIP/Postal Code
06800
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
10936130
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.
Results Reference
background
PubMed Identifier
15043239
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.
Results Reference
background
PubMed Identifier
12606909
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.
Results Reference
background
PubMed Identifier
11505346
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.
Results Reference
background
PubMed Identifier
27501016
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.
Results Reference
background

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

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