Comparison of Erector Spinae Plane Block and Transversus Thoracic Muscle Plane Block in Coronary Artery Surgery

NCT06709625 | Completed

• 1 other identifier: NigarAltindag1
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate postoperative pain intensity comparatively between erector spinae plane block and transversus thoracic muscle plane block in patients undergoing open coronary artery surgery. The primary question it aims to address is which of these two regional techniques causes less postoperative pain.

Conditions

Nerve Block; Coronary Artery Bypass; Anesthesia and Analgesia

Keywords

Erector spina plane block; Transversus thoracic plane block; Cardiothoracic surgery

Outcome Measures

Primary Outcomes (4)

• To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.

  VAS values will be recorded

  postoperatively 0, 4, 8, 12 and 24 hours

• To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.

  BPS values will be recorded

  postoperatively 0, 4, 8, 12 and 24 hours

• To evaluate the postoperative pain intensity of erector spinae plane block in comparison with transversus thoracis muscle plane block in patients undergoing open coronary artery surgery.

  Rescue analgesic dosages will be recorded

  postoperatively 0, 4, 8, 12 and 24 hours

• To evaluate the effects of erector spinae plane block on postoperative hemonidamy in patients undergoing open coronary artery surgery, in comparison with transversus thoracis muscle plane block.

  Systolic arterial pressure will be recorded

  postoperatively 0, 4, 8, 12 and 24 hours

Secondary Outcomes (7)

• Determine the incidence of block-related adverse events

  Neurological or cardiovascular events occurring within the first 30 minutes after block application will be monitored to evaluate local anesthesia toxicity.

• Determine the incidence of block-related adverse events

  Chest wall hematoma and pneumothorax are diagnosed by USG after block and before skin incision within the first 24 hours after block applications

• To record the incidence of other side effects due to opioid administration

  Postoperatively 0, 2, 4, 8, 12, 24 hours

• To record the incidence of other side effects due to opioid administration

  Postoperatively 0, 2, 4, 8, 12, 24 hours

• To record the incidence of other side effects due to opioid administration

  Postoperatively 0, 2, 4, 8, 12, 24 hours

Study Arms (2)

Group of patients who underwent erector spinae plane block

ACTIVE COMPARATOR

20 ml %0.25 bupivacaine solution will be given under the erector spinae muscle under USG guidance in the prone position and intraoperative and postoperative data will be recorded.

Procedure: Erector spina plane block (ESP)

Group of patients who undervent transversus thoracic plane block

ACTIVE COMPARATOR

20ml %0.25 bupivacaine solution will be given between the transversus thoracis muscle and the internal intercostal muscle under USG guidance in the supin position and intraoperative and postoperative data will be recorded.

Procedure: Transversus thoracis plane block

Interventions

Transversus thoracis plane block PROCEDURE

Transversus thoracis plane block will be applied to provide postoperative analgesia.

Group of patients who undervent transversus thoracic plane block

Erector spina plane block (ESP) PROCEDURE

Erector spina plane block will be applied to provide postoperative analgesia.

Group of patients who underwent erector spinae plane block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80 who will undergo elective coronary artery surgery in TR Ankara City Hospital cardiovascular surgery operating room will be included in the study.

You may not qualify if:

• Non-coronary artery surgery cases
• Re-operations
• Low EF (\<40%)
• psychiatric illness
• Those who have contraindications for block (infection at the block site, etc.)
• Patients who do not or cannot give consent to participate in the study

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06530, Turkey (Türkiye)

Location

Related Publications (12)

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 RESULT

• Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.

  PMID: 28564673 RESULT

• Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.

  PMID: 30197534 RESULT

• Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.

  PMID: 10927999 RESULT

• Barr LF, Boss MJ, Mazzeffi MA, Taylor BS, Salenger R. Postoperative Multimodal Analgesia in Cardiac Surgery. Crit Care Clin. 2020 Oct;36(4):631-651. doi: 10.1016/j.ccc.2020.06.003. Epub 2020 Aug 12.

  PMID: 32892818 RESULT

• Cosarcan SK, Sezer OA, Gurkahraman S, Ercelen O. Regional analgesia techniques for effective recovery from coronary artery bypass surgeries: a retrospective study involving the experience of a single center. J Cardiothorac Surg. 2022 Jul 6;17(1):170. doi: 10.1186/s13019-022-01923-6.

  PMID: 35794614 RESULT

• Gregory AJ, Grant MC, Manning MW, Cheung AT, Ender J, Sander M, Zarbock A, Stoppe C, Meineri M, Grocott HP, Ghadimi K, Gutsche JT, Patel PA, Denault A, Shaw A, Fletcher N, Levy JH. Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) Recommendations: An Important First Step-But There Is Much Work to Be Done. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):39-47. doi: 10.1053/j.jvca.2019.09.002. Epub 2019 Sep 7. No abstract available.

  PMID: 31570245 RESULT

• King M, Stambulic T, Hassan SMA, Norman PA, Derry K, Payne DM, El Diasty M. Median sternotomy pain after cardiac surgery: To block, or not? A systematic review and meta-analysis. J Card Surg. 2022 Nov;37(11):3729-3742. doi: 10.1111/jocs.16882. Epub 2022 Sep 13.

  PMID: 36098374 RESULT

• Cogan J. Pain management after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Sep;14(3):201-4. doi: 10.1177/1089253210378401.

  PMID: 20705642 RESULT

• Ritter MJ, Christensen JM, Yalamuri SM. Regional Anesthesia for Cardiac Surgery: A Review of Fascial Plane Blocks and Their Uses. Adv Anesth. 2021 Dec;39:215-240. doi: 10.1016/j.aan.2021.08.001. Epub 2021 Oct 1. No abstract available.

  PMID: 34715976 RESULT

• Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.

  PMID: 32032103 RESULT

• Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.

  PMID: 36581838 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nevriye Salman

  ankara bilkent city hospital, anesthesiology and reanimation clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group 1 patients will undergo bilateral erector spinae plane block. Heart rate (beats/min) and systolic arterial pressure (mmHg) will be measured before and after induction, after skin incision, after sternotomy, 30 minutes after weaning from CPB, and after sternum closure. VAS and BPS will be used to evaluate pain at 0, 4, 8, 12, 24 hours postoperatively. Group 2 patients will undergo transversus thoracic plane block and the same parameters as group 1 will be saved.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: November 29, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)