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

April 19, 2021 updated by: Koen Lapage, M.D., Algemeen Stedelijk Ziekenhuis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group: "Opioid Free Anesthesia with a pecto-intercostal fascial plane block"
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
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.
ACTIVE_COMPARATOR: Control group: "Traditional Opioid-based Anesthetic Regimen"
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
Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morphine consumption
Time Frame: Day 2
The total amount of morphine used postoperatively in the intensive care unit until discharge.
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time until extubation
Time Frame: Day 0
The time between ICU-arrival and extubation
Day 0
Mean visual analogue score (VAS) pain score at rest
Time Frame: Day 2
The mean VAS pain score at rest at 24 hours and 48 hours after extubation.
Day 2
Mean visual analogue score (VAS) pain score whilst coughing
Time Frame: Day 2
The mean VAS pain score whilst coughing at 24 hours and 48 hours after extubation.
Day 2
Incidence of postoperative nausea and vomiting
Time Frame: Day 2
Incidence of postoperative nausea and vomiting (PONV)
Day 2
Incidence of postoperative delirium
Time Frame: Day 2
Incidence of postoperative delirium using the Confusion Assessment Method for ICU
Day 2
Mean length of ICU stay
Time Frame: Day 2
The mean length of ICU stay, reported in hours.
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Algemeen Stedelijk Ziekenhuis

Investigators

  • Principal Investigator: Koen Lapage, M.D., Department of Anesthesiology, Pain and Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 1, 2021

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 19, 2021

First Posted (ACTUAL)

April 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APIC2021150303
  • 2021-002164-43 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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