Anesthesia, Local, Chronic Pain, Opioid Use Disorder, Post-cardiac Surgery, Post-operative Delirium, Post-operative Pain
Conditions
Brief summary
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
Detailed description
This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in: 1. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion. Secondary outcomes will be: 2. cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME 3. median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion 4. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion. 5.) Quality of Recovery -15 (QoR-15) score 24-96 hours post-surgery Tertiary outcomes will be: 6.) time from catheter insertion to extubation 7.) time from catheter insertion to first opioid analgesic provision following extubation 8.) time from catheter insertion to mobilization 9.) lengths of stay in the intensive care unit and the hospital 10.) postoperative nausea and vomiting - measured twice a day and antiemetic medication requirements for the 72 hours after catheter insertion 11.) opioid requirements following discharge from the hospital 12.) chronic post-sternotomy pain/disability (McGill Pain Questionnaire) 13.) participant-reported outcomes (PROMIS-29 survey) at 6 weeks and 3 months post surgery
Interventions
PROCEDUREIntermittent Superficial Parasternal Intercostal Plane Block - Experimental
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus after catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 5 mL 0.2% ropivacaine will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
PROCEDUREIntermittent Superficial Parasternal Intercostal Plane Block - Placebo
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing after catheter placement (20 mL placebo(0.9% saline)), intermittent boluses of 5 mL Placebo(0.9% saline) will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
Sponsors
Unity Health Toronto
Queen Elizabeth II Health Sciences Centre
Foothills Medical Centre
Royal Columbian Hospital Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The patient, intervention appliers (i.e. the operating room staff), medical practitioners, and outcome assessors will all be blinded to the randomized treatment arm until the database is locked. Unblinding procedures will be made available for breaking codes if necessary for clinical treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing cardiac surgery via median sternotomy
Exclusion criteria
* Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.) * Emergency procedures (surgery within 2 hours) * Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study * Weight \< 50kg * Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections * Surgery for infective endocarditis * Pregnancy or nursing * Chronic opioid/narcotic use \> 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes * Allergies to amide anesthetic agents or any components of study interventions * Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.) * Receipt of an investigational drug or device within past 7 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative postoperative opioid use up to 72 hours | 72 hours after catheter insertion. | Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median pain score | over 72 hours post-extubation | Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) twice daily |
| Cumulative post-operative opioid use | Average of 5 days. | Measured total opioid use from the time of catheter insertion until discharge from hospital |
| Delirium | for 72 hours following catheter insertion | assessed twice daily using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist. |
| Quality of Recovery-15 Scale | 24-96 hours post surgery | Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome) |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORAhmad Alli, MD
Unity Health Toronto
Outcome results
None listed