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

NCT04928521 | Completed

• 1 other identifier: MH2.3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery; Postoperative Pain

Keywords

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

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (2)

• Mechanical ventilation duration

  postoperative, approximately 4 to 10 hours

• intensive care unit duration

  postoperative, approximately 12 to 36 hours

Study Arms (2)

ESP block with 20 mL local anesthetic solution

ACTIVE COMPARATOR

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

ESP block with 30 mL local anesthetic solution

ACTIVE COMPARATOR

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

Interventions

bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine PROCEDURE

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

Also known as: 30 mL

ESP block with 30 mL local anesthetic solution

bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine PROCEDURE

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

Also known as: 20 mL

ESP block with 20 mL local anesthetic solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who will undergo coronary artery bypass grafting surgery with median sternotomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Select State/Province, 06800, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 10936130 BACKGROUND

• 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.

  PMID: 15043239 BACKGROUND

• 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.

  PMID: 12606909 BACKGROUND

• 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.

  PMID: 11505346 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• ZELİHA A DEMİR

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 16, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

TU (1)