Opioid Use of Local Anaesthetic Agents in Open Heart Surgery and Its Effect on Recovery

NCT06642077 | Completed

• 1 other identifier: 2023/19-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled study was to investigate the effect of injecting local anesthetic agents into the sternotomy incision site and around the drains on the amount of opioids used in the postoperative period and the healing process. The main questions it aims to answer are:

• In patients undergoing open heart surgery, does the application of local anesthetic around the sternotomy incision site and chest tube(s) reduce the amount of postoperative opioid use?
• In patients undergoing open heart surgery, does the application of local anesthetic around the sternotomy incision site and chest tube(s) accelerate postoperative recovery? In this study, LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml will be injected into the sternotomy incision area and around the drains of the patients in the experimental group, and the amount of opioid consumed in the postoperative period will be recorded and the healing process will be observed.

Conditions

Analgesics, Opioid; Anesthetics, Local

Keywords

Cardiovascular surgery; Pain management; Local anesthetics; Recovery after surgery; Opioids

Outcome Measures

Primary Outcomes (1)

• Amount of Opioid Consumed in the Postoperative Period

  After open heart surgery, LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml will be injected into the sternotomy incision area and around the drains of the patients in the experimental group, and the amount of opioid consumed in the postoperative period will be recorded and compared with the control group.

  First 24 hours after open heart surgery

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

A total of 2 ampoules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml were injected into the sternotomy incision site and around the chest tubes of 30 patients in the experimental group. The total number and dose of opioids, the total number and dose of analgesics used to relieve the pain of the patients in the 24 hours after the injection of 2 ampules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml, and the total number and dose of analgesics were recorded, and the patients were interviewed face-to-face 24 hours later, and Postoperative Recovery Index (PoRI) was recorded.

Drug: LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml

CONTROL GROUP

NO INTERVENTION

No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients.

Interventions

LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml DRUG

A total of 2 ampoules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml were injected into the sternotomy incision site and around the chest tubes of 30 patients in the experimental group. The total number and dose of opioids, the total number and dose of analgesics used to relieve the pain of the patients in the 24 hours after the injection of 2 ampules of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml, and the total number and dose of analgesics were recorded, and the patients were interviewed face-to-face 24 hours later, and PoRI was recorded. No intervention was performed on 30 patients in the control group, and standard treatment and care continued to be applied to these patients.

Also known as: Application of LIDOFAST 40 mg/2 ml + 0.025 mg/2 ml to the sternotomy incision area and around the drains

EXPERIMENTAL GROUP

Eligibility Criteria

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

You may qualify if:

• patients between 18 and 65 years of age, and willing to communicate and cooperate after open heart surgery

You may not qualify if:

• Patients younger than 18 years and older than 65 years, unwilling to communicate and cooperate, sensitive to local anaesthetics and not willing to participate in the study

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yüzüncü Yil University

Van, Turkey (Türkiye)

Location

Related Publications (11)

• Ebrahimi S, Paryad E, Ghanbari Khanghah A, Pasdaran A, Kazemnezhad Leili E, Sadeghi Meibodi AM. The effects of lavandula aromatherapy on pain relief after coronary artery bypass graft surgery: A randomized clinical trial. Appl Nurs Res. 2022 Dec;68:151638. doi: 10.1016/j.apnr.2022.151638. Epub 2022 Oct 28.

  PMID: 36473717 RESULT

• Choiniere M, Watt-Watson J, Victor JC, Baskett RJ, Bussieres JS, Carrier M, Cogan J, Costello J, Feindel C, Guertin MC, Racine M, Taillefer MC. Prevalence of and risk factors for persistent postoperative nonanginal pain after cardiac surgery: a 2-year prospective multicentre study. CMAJ. 2014 Apr 15;186(7):E213-23. doi: 10.1503/cmaj.131012. Epub 2014 Feb 24.

  PMID: 24566643 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

• White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.

  PMID: 14508326 RESULT

• Dowling R, Thielmeier K, Ghaly A, Barber D, Boice T, Dine A. Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1271-8. doi: 10.1016/s0022-5223(03)00585-3.

  PMID: 14665996 RESULT

• Golembiewski J. Local anesthetics. J Perianesth Nurs. 2013 Dec;28(6):409-12. doi: 10.1016/j.jopan.2013.09.001. No abstract available.

  PMID: 24267631 RESULT

• Shah J, Votta-Velis EG, Borgeat A. New local anesthetics. Best Pract Res Clin Anaesthesiol. 2018 Jun;32(2):179-185. doi: 10.1016/j.bpa.2018.06.010. Epub 2018 Jul 3.

  PMID: 30322458 RESULT

• Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.

  PMID: 31417264 RESULT

• Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.

  PMID: 32584934 RESULT

• Reisli R, Akkaya OT, Arican S, Can OS, Cetingok H, Gulec MS, Koknel Talu G. [Pharmachologic treatment of acute postoperative pain: A clinical practice guideline of The Turkish Society of Algology]. Agri. 2021 Jan;33(Suppl 1):1-51. doi: 10.14744/agri.2021.60243. Turkish.

  PMID: 33523457 RESULT

• Azizoglu H, Asam M, Gurkan Z, Bozkurt Y, Demir C. The effect of local anaesthetic agents on opioid use and recovery in patients undergoing open heart surgery: a randomized controlled study. BMC Cardiovasc Disord. 2025 Feb 1;25(1):72. doi: 10.1186/s12872-025-04493-2.

  PMID: 39893373 DERIVED

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

• Hatice Azizoğlu

  Yuzuncu Yil University

  PRINCIPAL INVESTIGATOR

• Mehmet Aşam

  Van Training and Research Hospital

  STUDY CHAIR

• Zeynep Gürkan

  Yuzuncu Yil University

  STUDY CHAIR

• Yasemin Bozkurt

  Van Training and Research Hospital

  STUDY CHAIR

• Canan Demir

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Model Details: This randomized controlled experimental study was conducted with a total of 60 patients, with 30 patients in the experimental group and 30 patients in the control group.

Study Record Dates

• First Submitted: October 13, 2024
• First Posted: October 15, 2024
• Study Start: August 1, 2023
• Primary Completion: January 15, 2024
• Study Completion: March 15, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)