Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.

NCT04854577 | Unknown

• 2 other identifiers: APIC20211503032021-002164-43
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study aims to assess the difference in postoperative opioid consumption between patients who intraoperatively receive a pecto-intercostal facial block combined with opioid-free anesthesia versus a traditional opioid-based regimen for cardiac surgery. The literature on opioid-free anesthesia for cardiac surgery is minimal and solely consists of case reports and retrospective studies. Nevertheless, these reports show the feasibility of opioid-free anesthesia. The purpose of this study is to assess the opioid-sparing effect and efficacy of combining an opioid-free anesthetic regimen with a pecto-intercostal fascial plane block (PIFB) in patients undergoing cardiac surgery. We hypothesize that opioid-free cardiac anesthesia with an intraoperative PIFB significantly reduces postoperative opioid consumption in comparison to a high-dose opioid intraoperative regimen.

Conditions

Opioid Free Anaesthesia; Opioid Anaesthesia

Keywords

Analgesics, Opioid; Anesthetics; Central Nervous System Depressants; Dexmedetomidine; Esketamine; Lidocaine; Ropivacaine; Pecto-Intercostal Fascial Plane Block; Physiological Effects of Drugs; Peripheral Nervous System Agents

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  The total amount of morphine used postoperatively in the intensive care unit until discharge.

  Day 2

Secondary Outcomes (6)

• Time until extubation

  Day 0

• Mean visual analogue score (VAS) pain score at rest

  Day 2

• Mean visual analogue score (VAS) pain score whilst coughing

  Day 2

• Incidence of postoperative nausea and vomiting

  Day 2

• Incidence of postoperative delirium

  Day 2

Study Arms (2)

Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block"

EXPERIMENTAL

Patients to whom a standardized opioid free anesthesia consisting of esketamine, lidocaine and dexmedetomidine will be administered with a pre-incisional pecto-intercostal fascial plane block.

Procedure: Opioid Free Anesthesia

Control group: "Traditional Opioid-based Anesthetic Regimen"

ACTIVE COMPARATOR

Patients who will receive a traditional opioid based anesthetic regimen. The administered dose of opioids is at the discretion of the attending anesthesiologist.

Procedure: Traditional Anesthetic Regimen

Interventions

Opioid Free Anesthesia PROCEDURE

Patients will be administered a combination of a pre-incisional pecto-intercostal fascial plane block and a standardized opioid free anesthetic regimen consisting of dexmedetomidine, esketamine and lidocaine.

Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block"

Traditional Anesthetic Regimen PROCEDURE

Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.

Control group: "Traditional Opioid-based Anesthetic Regimen"

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older
• Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.

You may not qualify if:

• CABG surgery which did not include a complete midline sternotomy
• Valve surgery
• Aortic surgery
• Emergency cardiac surgery
• Known allergy for ropivacaine
• Participation in another clinical trial
• Known drug abuse
• Preoperative cognitive dysfunction
• Preoperative pain therapy with opioids or anticonvulsants 14 days before surgery
• Patients unable to use Patient Controlled Analgesia (PCA)
• Need of reintubation after initial extubation

Sponsors & Collaborators

• Algemeen Stedelijk Ziekenhuis: lead

Related Publications (19)

• 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

• Bignami E, Castella A, Pota V, Saglietti F, Scognamiglio A, Trumello C, Pace MC, Allegri M. Perioperative pain management in cardiac surgery: a systematic review. Minerva Anestesiol. 2018 Apr;84(4):488-503. doi: 10.23736/S0375-9393.17.12142-5. Epub 2017 Oct 12.

  PMID: 29027773 BACKGROUND

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  PMID: 14622770 BACKGROUND

• Ochroch J, Usman A, Kiefer J, Pulton D, Shah R, Grosh T, Patel S, Vernick W, Gutsche JT, Raiten J. Reducing Opioid Use in Patients Undergoing Cardiac Surgery - Preoperative, Intraoperative, and Critical Care Strategies. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):2155-2165. doi: 10.1053/j.jvca.2020.09.103. Epub 2020 Sep 15.

  PMID: 33069556 BACKGROUND

• Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013 Apr;33(4):383-91. doi: 10.1002/phar.1223.

  PMID: 23553809 BACKGROUND

• Hagemeier NE. Introduction to the opioid epidemic: the economic burden on the healthcare system and impact on quality of life. Am J Manag Care. 2018 May;24(10 Suppl):S200-S206.

  PMID: 29851449 BACKGROUND

• Shipton EA, Shipton EE, Shipton AJ. A Review of the Opioid Epidemic: What Do We Do About It? Pain Ther. 2018 Jun;7(1):23-36. doi: 10.1007/s40122-018-0096-7. Epub 2018 Apr 6.

  PMID: 29623667 BACKGROUND

• Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790.

  PMID: 29343479 BACKGROUND

• Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.

  PMID: 24519537 BACKGROUND

• Cardinale JP, Gilly G. Opiate-Free Tricuspid Valve Replacement: Case Report. Semin Cardiothorac Vasc Anesth. 2018 Dec;22(4):407-413. doi: 10.1177/1089253218771342. Epub 2018 Apr 20.

  PMID: 29676223 BACKGROUND

• Chanowski EJP, Horn JL, Boyd JH, Tsui BCH, Brodt JL. Opioid-Free Ultra-Fast-Track On-Pump Coronary Artery Bypass Grafting Using Erector Spinae Plane Catheters. J Cardiothorac Vasc Anesth. 2019 Jul;33(7):1988-1990. doi: 10.1053/j.jvca.2018.10.012. Epub 2018 Oct 13. No abstract available.

  PMID: 30424939 BACKGROUND

• Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.

  PMID: 31366330 BACKGROUND

• Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.

  PMID: 31356362 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

• Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.

  PMID: 31833864 BACKGROUND

• Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.

  PMID: 32798172 BACKGROUND

• Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.

  PMID: 32859487 BACKGROUND

• Chan JL, Miller JG, Murphy M, Greenberg A, Iraola M, Horvath KA. A Multidisciplinary Protocol-Driven Approach to Improve Extubation Times After Cardiac Surgery. Ann Thorac Surg. 2018 Jun;105(6):1684-1690. doi: 10.1016/j.athoracsur.2018.02.008. Epub 2018 Mar 9.

  PMID: 29530778 BACKGROUND

• Berthoud V, Ellouze O, Nguyen M, Konstantinou M, Aho S, Malapert G, Girard C, Guinot PG, Bouchot O, Bouhemad B. Serratus anterior plane block for minimal invasive heart surgery. BMC Anesthesiol. 2018 Oct 20;18(1):144. doi: 10.1186/s12871-018-0614-5.

  PMID: 30340525 BACKGROUND

Study Officials

• Koen Lapage, M.D.

  Department of Anesthesiology, Pain and Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Lapage, M.D.

CONTACT

+32 53 764180; koen.lapage@asz.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will not be made aware of what has been administered. The outcome assessor will be blinded for the group allocation of patients. The investigator, as one of the care providers, nor the care providers can be blinded for the administered anesthetic regimen. The opioid free anesthetic regimen will be conducted by the same anesthesiologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiology

Model Details: A randomized controlled, outcome assessor blinded study using two parallel study groups

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share