Opioid Free AnaesthesiaNCT04854577
Postoperative Opioid-Sparing Effect of a Pecto-Intercostal Fascial Block and Opioid-Free Anesthesia.
A study testing Opioid Free Anesthesia and Traditional Anesthetic Regimen in people with Opioid Free Anaesthesia and Opioid Anaesthesia, run by Algemeen Stedelijk Ziekenhuis.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Free Anaesthesia, Opioid Anaesthesia
- What is being tested?
- Opioid Free Anesthesia and Traditional Anesthetic Regimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the detailed 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:
- "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB);
- "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.
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Being tested
- Opioid Free Anesthesia, Traditional Anesthetic Regimen
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnesthesiaProcedure or surgery
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 RegimenProcedure or surgery
Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Traditional Anesthetic Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
The total amount of morphine used postoperatively in the intensive care unit until discharge.
Measured: Day 2
Secondary outcomes (6)
Time until extubation
The time between ICU-arrival and extubation
Measured: 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.
Measured: 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.
Measured: Day 2
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (PONV)
Measured: Day 2
Incidence of postoperative delirium
Incidence of postoperative delirium using the Confusion Assessment Method for ICU
Measured: Day 2
Mean length of ICU stay
The mean length of ICU stay, reported in hours.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Opioid Free AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled, outcome assessor blinded study using two parallel study groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Stedelijk Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koen Lapage, M.D., Algemeen Stedelijk Ziekenhuis
- Investigators
- Koen Lapage, M.D., Principal investigator, Department of Anesthesiology, Pain and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854577
- Sponsor's protocol ID
- APIC2021150303
- Other IDs
- 2021-002164-43
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30064852Bignami 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.
PubMed 29027773Wheeler 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.
PubMed 14622770Ochroch 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.
PubMed 33069556Kessler 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.
PubMed 23553809Hagemeier 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.
PubMed 29851449Shipton 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.
PubMed 29623667Brat 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.
PubMed 29343479Clarke 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.
PubMed 24519537Cardinale 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.
PubMed 29676223Chanowski 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.
PubMed 30424939Guinot 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.
PubMed 31366330Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.
PubMed 31356362Landoni 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.
PubMed 26089444Smith 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.
PubMed 31833864
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04854577
- Acronym / sponsor ID
- APIC2021150303
- Conditions
- Opioid Free Anaesthesia, Opioid Anaesthesia
- Keywords
- Analgesics, Opioid, Anesthetics, Central Nervous System Depressants, Dexmedetomidine, Esketamine, Lidocaine, Ropivacaine, Pecto-Intercostal Fascial Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Algemeen Stedelijk ZiekenhuisUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- "Intervention" group: Opioid-free anesthetic regimen with a pre-incisional pecto-intercostal fascial plane block (PIFB);
- "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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled, outcome assessor blinded study using two parallel study groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block" | Experimental | Procedure: Opioid Free AnesthesiaPatients 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. |
| Control group: "Traditional Opioid-based Anesthetic Regimen" | Active comparator | Procedure: Traditional Anesthetic RegimenPatients who will receive a traditional opioid based anesthetic regimen. The administered dose of opioids is at the discretion of the attending anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 years or older
- Patients scheduled for coronary artery bypass graft surgery (CABG), which includes a complete midline sternotomy.
Key exclusion criteria (11 listed)
- CABG surgery which did not include a complete midline sternotomy
- Valve surgery
- Aortic surgery
- Emergency cardiac surgery
- Known allergy for ropivacaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid Free AnesthesiaPatients 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. | Procedure or surgery | Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block" |
| Traditional Anesthetic RegimenPatients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist. | Procedure or surgery | Control group: "Traditional Opioid-based Anesthetic Regimen" |
Primary outcome
Postoperative morphine consumption
Time frame: Day 2
The total amount of morphine used postoperatively in the intensive care unit until discharge.
6 secondary outcomes
Time until extubation
Time frame: Day 0
Mean visual analogue score (VAS) pain score at rest
Time frame: Day 2
Mean visual analogue score (VAS) pain score whilst coughing
Time frame: Day 2
Incidence of postoperative nausea and vomiting
Time frame: Day 2
Incidence of postoperative delirium
Time frame: Day 2
Mean length of ICU stay
Time frame: Day 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Background: PubMed 30064852Kwanten 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.
- Background: PubMed 29027773Bignami 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.
- Background: PubMed 14622770Wheeler 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.
- Background: PubMed 33069556Ochroch 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.
- Background: PubMed 23553809Kessler 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.
- Background: PubMed 29851449Hagemeier 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.
- Background: PubMed 29623667Shipton 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.
- Background: PubMed 29343479Brat 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.
- Background: PubMed 24519537Clarke 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.
- Background: PubMed 29676223Cardinale 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.
- Background: PubMed 30424939Chanowski 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.
- Background: PubMed 31366330Guinot 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koen Lapage, M.D. principal investigator
Department of Anesthesiology, Pain and Intensive Care Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Free Anesthesia and Traditional Anesthetic Regimen in people with Opioid Free Anaesthesia and Opioid Anaesthesia, run by Algemeen Stedelijk Ziekenhuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Koen Lapage, M.D. (+32 53 764180, koen.lapage@asz.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04854577, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.