The Effect of Parasternal Block on Postoperative Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery

NCT06893601 | Completed Phase 2 FDA Drug

• 1 other identifier: 97479326-050.04.04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aims to investigate the effects of intraoperative parasternal block on postoperative analgesia in patients undergoing elective coronary artery bypass graft surgery. Materials and Methods: This prospective, randomized, double-blind study included 78 patients aged 30-80 years with an ASA (American Society of Anesthesiologists) risk score of III-IV, who were scheduled for elective coronary artery bypass graft surgery. Patients were randomly assigned into two groups: the parasternal block group (n = 39), receiving parasternal block with 2.5% bupivacaine, and the saline group (n = 39), receiving parasternal block with 0.9% NaCl. All patients were administered a standard anesthesia protocol, and routine care and analgesia practices during the postoperative period were not interfered with. Patients in the intensive care unit received intravenous paracetamol every 8 hours for analgesia. If postoperative 24-hour pain scores in the intensive care unit , assessed using the Behavioral Pain Scale while intubated and the Numeric Rating Scale while extubated, exceeded 4, 1 mg/kg tramadol was administered. The timing and doses of the first tramadol administration, as well as extubation times, intensive care unit stay durations, and discharge times, were recorded. Results: In the postoperative period, Behavioral Pain Scale scores at the 8th hour and Numeric Rating Scale scores at the 4th and 12th hours were significantly lower in the parasternal block group compared to the saline group (p \< 0.005). The average extubation time was 8.76 hours in the parasternal block group and 14.76 hours in the saline group (p \< 0.001). Among patients with pain scores of 4 or higher, the total tramadol consumption in the parasternal block group was 150 ± 64.72 mg, with the first tramadol administration occurring at 17.26 ± 4.78 hours. In the saline group, total tramadol consumption was 212.5 ± 82.23 mg, and the first administration occurred at 12.35 ± 5.75 hours. Conclusion: Our study demonstrated that parasternal block, as a component of multimodal analgesia, improved postoperative analgesia levels in coronary artery bypass graft surgery. Therefore, the investigators consider parasternal block to be effective in pain management following median sternotomy.

Conditions

Postoperative Pain; ICU Hospitalization; Extubation Time

Keywords

Parasternal Block; Postoperative Analgesia; Coronary Artery Bypass Graft Surgery

Outcome Measures

Primary Outcomes (2)

• The Effect of Parasternal Block on Postoperative Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery

  Pain assessment began upon the patient's admission to the ICU and was conducted using the Behavioral Pain Scale at the 1st, 2nd, 4th, and 8th hours while intubated. The lowest score obtained from the scale is 3, and the highest score is 12. An increase in the score indicates an increase in the level of pain.

  First 24 Hours in the Intensive Care Unit

• The Effect of Parasternal Block on Postoperative Pain in Patients Undergoing Coronary Artery Bypass Graft Surgery

  After extubation, pain was assessed using the Numeric Rating Scale at the 1st, 4th, and 12th hours. Patients report the severity of pain they feel on a scale where 0 indicates no pain and 10 indicates the most severe pain imaginable.

  First 24 Hours in the Intensive Care Unit

Study Arms (2)

Saline group

PLACEBO COMPARATOR

The saline group received a bilateral parasternal block with 0.9% NaCl solution.

Drug: Parasternal block

Parasternal block group

EXPERIMENTAL

Parasternal block group, bilateral parasternal block was performed using 0.25% bupivacaine.

Drug: Parasternal block

Interventions

Parasternal block DRUG

A block containing 0.9% NaCl solution was applied to the Saline group just before the sternum was closed by the surgeon, while a bilateral parasternal block using 0.25% bupivacaine was applied to the bupivacaine group. The solutions used for the parasternal block were colorless and indistinguishable to ensure blinding.

Parasternal block group; Saline group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study included patients aged 30-80 years
• American Society of Anesthesiologists risk score of III-IV,
• Who were scheduled for elective Coronary Artery Bypass Graft Surgery.

You may not qualify if:

• In this study, patients with hypersensitivity to the medications used,
• Patients under 30 years or over 80 years of age,
• Patients with chronic opioid use or severe psychiatric disorders,
• Patients who did not provide informed consent, patients with infection at the injection site,
• Patients with preoperative left ventricular ejection fraction \<30%,
• Patients with a history of previous sternotomy,
• Patients with severe renal or liver diseases,
• Patients unable to communicate.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydin Adnan Menderes University

Aydin, EFELER, Turkey (Türkiye)

Location

Related Publications (19)

• Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26.

  PMID: 38537393 BACKGROUND

• Coriat P, Beaussier M. Fast-tracking after coronary artery bypass graft surgery. Anesth Analg. 2001 May;92(5):1081-3. doi: 10.1097/00000539-200105000-00001. No abstract available.

  PMID: 11323325 BACKGROUND

• Schiavoni L, Nenna A, Cardetta F, Pascarella G, Costa F, Chello M, Agro FE, Mattei A. Parasternal Intercostal Nerve Blocks in Patients Undergoing Cardiac Surgery: Evidence Update and Technical Considerations. J Cardiothorac Vasc Anesth. 2022 Nov;36(11):4173-4182. doi: 10.1053/j.jvca.2022.07.025. Epub 2022 Jul 24.

  PMID: 35995636 BACKGROUND

• Dogan Baki E, Kavrut Ozturk N, Ayoglu RU, Emmiler M, Karsli B, Uzel H. Effects of Parasternal Block on Acute and Chronic Pain in Patients Undergoing Coronary Artery Surgery. Semin Cardiothorac Vasc Anesth. 2016 Sep;20(3):205-12. doi: 10.1177/1089253215576756. Epub 2015 Apr 21.

  PMID: 25900900 BACKGROUND

• Schwann NM, Chaney MA. No pain, much gain? J Thorac Cardiovasc Surg. 2003 Nov;126(5):1261-4. doi: 10.1016/s0022-5223(03)01327-8. No abstract available.

  PMID: 14665993 BACKGROUND

• Grant MC, Chappell D, Gan TJ, Manning MW, Miller TE, Brodt JL; PeriOperative Quality Initiative (POQI) and the Enhanced Recovery After Surgery (ERAS) Cardiac Society Workgroup. Pain management and opioid stewardship in adult cardiac surgery: Joint consensus report of the PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Society. J Thorac Cardiovasc Surg. 2023 Dec;166(6):1695-1706.e2. doi: 10.1016/j.jtcvs.2023.01.020. Epub 2023 Jan 28.

  PMID: 36868931 BACKGROUND

• Hassan S, Stambulic T, King M, Norman P, Payne D, Derry K, et al. Post-Operatıve Paın And Analgesıc Use For Cardıac Surgery Wıth Medıan Sternotomy. Canadian Journal of Cardiology. 2021 Oct 1;37(10):S107-8.

  BACKGROUND

• Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

  PMID: 17678782 BACKGROUND

• Padala SRAN, Badhe AS, Parida S, Jha AK. Comparison of preincisional and postincisional parasternal intercostal block on postoperative pain in cardiac surgery. J Card Surg. 2020 Jul;35(7):1525-1530. doi: 10.1111/jocs.14651. Epub 2020 Jun 24.

  PMID: 32579779 BACKGROUND

• 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 BACKGROUND

• Fuchs A, Heinisch PP, Luedi MM, Reid CS. Pain after cardiac surgery: Time to include multimodal pain management concepts in ERAS protocols. J Clin Anesth. 2022 Feb;76:110583. doi: 10.1016/j.jclinane.2021.110583. Epub 2021 Nov 10. No abstract available.

  PMID: 34768206 BACKGROUND

• Landoni G, Isella F, Greco M, Zangrillo A, Royse CF. Benefits and risks of epidural analgesia in cardiac surgery. Br J Anaesth. 2015 Jul;115(1):25-32. doi: 10.1093/bja/aev201.

  PMID: 26089444 BACKGROUND

• McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. doi: 10.1213/01.ANE.0000139652.84897.BD.

  PMID: 15616047 BACKGROUND

• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.

  PMID: 16698416 BACKGROUND

• Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.

  PMID: 25500688 BACKGROUND

• Kwanten LE, O'Brien B, Anwar S. Opioid-Based Anesthesia and Analgesia for Adult Cardiac Surgery: History and Narrative Review of the Literature. J Cardiothorac Vasc Anesth. 2019 Mar;33(3):808-816. doi: 10.1053/j.jvca.2018.05.053. Epub 2018 Jun 5.

  PMID: 30064852 BACKGROUND

• Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.

  PMID: 25796483 BACKGROUND

• Reinhart M, Jonsson M, Enthoven P, Westerdahl E. Immediate effects of upper limb exercises with and without deep breathing on lung function after cardiac surgery - a randomized crossover trial. J Cardiothorac Surg. 2024 Aug 28;19(1):503. doi: 10.1186/s13019-024-03007-z.

  PMID: 39198875 BACKGROUND

• Nalysnyk L, Fahrbach K, Reynolds MW, Zhao SZ, Ross S. Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. Heart. 2003 Jul;89(7):767-72. doi: 10.1136/heart.89.7.767.

  PMID: 12807853 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Meryem Nil KAAN, Prof. Dr.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 25, 2025
• Study Start: January 18, 2020
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)