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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002164-43 | EudraCT Number |
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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.
Patients, aged 18 years or older, scheduled for coronary artery bypass graft surgery (CABG) with a complete midline sternotomy as surgical approach will be recruited for this study.
Patients planned for this particular surgical procedure will be recruited and allocated to one of 2 groups:
Based on our power analysis, each group will consist of 64 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine consumption | The total amount of morphine used postoperatively in the intensive care unit until discharge. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Time until extubation | The time between ICU-arrival and extubation | Day 0 |
| Mean visual analogue score (VAS) pain score at rest | The mean VAS pain score at rest at 24 hours and 48 hours after extubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Koen Lapage, M.D. | Contact | +32 53 764180 | koen.lapage@asz.be |
| Name | Affiliation | Role |
|---|---|---|
| Koen Lapage, M.D. | Department of Anesthesiology, Pain and Intensive Care Medicine | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30064852 | 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. | |
| 29027773 | 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. |
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A randomized controlled, outcome assessor blinded study using two parallel study groups
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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.
| 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. |
|
| Day 2 |
| Mean visual analogue score (VAS) pain score whilst coughing | The mean VAS pain score whilst coughing at 24 hours and 48 hours after extubation. | Day 2 |
| Incidence of postoperative nausea and vomiting | Incidence of postoperative nausea and vomiting (PONV) | Day 2 |
| Incidence of postoperative delirium | Incidence of postoperative delirium using the Confusion Assessment Method for ICU | Day 2 |
| Mean length of ICU stay | The mean length of ICU stay, reported in hours. | Day 2 |
| 14622770 | Background | Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available. |
| 33069556 | 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. |
| 23553809 | 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. |
| 29851449 | 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. |
| 29623667 | 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. |
| 29343479 | 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. |
| 24519537 | 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. |
| 29676223 | 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. |
| 30424939 | 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. |
| 31366330 | 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. |
| 31356362 | 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. |
| 26089444 | 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. |
| 31833864 | 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. |
| 32798172 | 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. |
| 32859487 | 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. |
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