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

Opioid Free Anaesthesia Clinical Trial

Official title:

The Postoperative Opioid-Sparing Effect of an Intraoperative Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia in Cardiac Surgery Patients: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04854577
• Other study ID #: APIC2021150303
• Secondary ID: 2021-002164-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: September 2022

Study information

• Verified date: April 2021
• Source: Algemeen Stedelijk Ziekenhuis
• Contact: Koen Lapage, M.D.
• Phone: +32 53 764180
• Email: koen.lapage[@]asz.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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: 1. "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB); 2. "Control" group: traditional opiate-based anesthetic regimen in which the dosage of the opioids is at the discretion of the attending anesthesiologist. Based on our power analysis, each group will consist of 64 patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: September 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Opioid Anaesthesia
• Opioid Free Anaesthesia

Intervention

Procedure:
• Opioid Free Anesthesia
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.
• Traditional Anesthetic Regimen
Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Algemeen Stedelijk Ziekenhuis

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. 2020 Sep 15. pii: S1053-0770(20)31018-1. doi: 10.1053/j.jvca.2020.09.103. [Epub ahead of print] Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine consumption	The total amount of morphine used postoperatively in the intensive care unit until discharge.	Day 2
Secondary	Time until extubation	The time between ICU-arrival and extubation	Day 0
Secondary	Mean visual analogue score (VAS) pain score at rest	The mean VAS pain score at rest at 24 hours and 48 hours after extubation.	Day 2
Secondary	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
Secondary	Incidence of postoperative nausea and vomiting	Incidence of postoperative nausea and vomiting (PONV)	Day 2
Secondary	Incidence of postoperative delirium	Incidence of postoperative delirium using the Confusion Assessment Method for ICU	Day 2
Secondary	Mean length of ICU stay	The mean length of ICU stay, reported in hours.	Day 2