Chronic post-sternotomy pain after cardiac surgery Circulatory System
Conditions
Interventions
This study will be a multi-centre, parallel, 2-arm, randomised controlled feasibility trial with 1:1 allocation of pectoralis-intercostal-rectus sheath plane(PIRS) block versus usual practice.
The p
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 16 years old or over 2. Having elective coronary artery bypass grafting (CABG) only 3. Able to provide informed consent 4. American Society of Anaesthesiologists physical status I, II or III
Exclusion criteria
Exclusion criteria: 1. Contraindication to regional techniques, e.g., known allergy to local anaesthetics; infection near the proposed puncture site; severe coagulation disorders (in the clinician’s opinion) 2. Pregnancy 3. Surgery for combined coronary artery bypass grafting (CABG) and valve surgery 4. Previous median sternotomy within 3 months 5. Likely inability to comply with completion of the study questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of a subsequent phase III RCT, based on an assessment of feasibility outcomes, including randomisation (the proportion of the participants scheduled to receive CABG who meet eligibility criteria and eligible participants randomised into the study), retention (the proportion of participants progressing to 6-month follow-up), intervention training experience (the proportion of certificates awarded), acceptability of outcome data (proportion of participants completing PRO data), and adherence (proportion of participants receiving their allocated treatment) measured using data collected from screening and randomisation records, the number of 6-month follow-up forms received, study competency certification, the number of PRO questionnaires received, and intervention Case Report Forms at data collection | — |
Secondary
| Measure | Time frame |
|---|---|
| Medication taken throughout the post-op hospital stay, based on analgesic use reported measured using data collected from discharge case report forms at data collection;Length of CICU and hospital stay measured using data collected from discharge case report forms at data collection;Complications and defined perioperative side effects measured using data collected from discharge case report forms at data collection;In-hospital mortality measured using data collected from discharge case report forms at data collection;Interference measured using the Brief Pain Inventory (BPI) at baseline, discharge, 3 months, and 6 months;Pain measured using the Numeric Pain Scale (NPS) at 24, 48 and 72 h post-operation and at discharge;Symptoms, Physical functioning, Psychosocial functioning, Cognitive functioning, Adverse effects, Satisfaction measured using the Coronary Revascularisation Outcome Questionnaire (CROQ) at baseline, 3 and 6 months;Health-related quality of life measured using the EQ-5D-5L at baseline, 3 and 6 months;Depression and Anxiety measured using the Hospital Anxiety and Depression Scale questionnaire (HADS) at baseline, 3 and 6 months;Satisfaction with pain therapy after surgery and hospital care measured using patient satisfaction with overall care and pain relief questionnaires at discharge | — |
Countries
England, United Kingdom
Contacts
Public ContactMary Nulty
Outcome results
None listed