None listed
Conditions
Brief summary
Aim of this randomized controlled trial is to evaluate multimodal pain management approach for site acute and chronic pain development, Outcomes, Quality of Life in patients with Ischemic Heart Disease after Percutaneous Coronary Intervention (PCI). We will enroll 560 patients that they will be divided in to groups: intervention and control. Intervention group will get multi-modal pain management (regular medication and physiotherapy, if needed pain physician will be involved for additional adjuvant therapy). Control group will get pain relief as needed and it will be provided by cardiologist who is taking care of the patient according to local pain management practice. We assume that the study will help improve pain management following frequent PCI interventions, reduce the side effects of medicines used, improve the outcome of ischemic heart disease (IHD) patient satisfaction, and timely detection and / or prevention of complications associated with intervention, including chronic pain syndrome.
Interventions
Multimodal pain management approach. Multimodal pain management for site pain after Percutaneous Coronary Intervention (PCI) in patients with ischemic heart disease. Place: Cardiology department. The approximate duration of the intervention depends on interventional cardiologist (30- 120 minutes). Intervention includes pain management with multimodal approach: pain assessment (before the procedure, immediately after the procedure2, 12, 24, 48 hours, 1 week, 1 month, and 3-6 month after the proce
Multimodal pain management approach. Multimodal pain management for site pain after Percutaneous Coronary Intervention (PCI) in patients with ischemic heart disease. Place: Cardiology department. The approximate duration of the intervention depends on interventional cardiologist (30- 120 minutes). Intervention includes pain management with multimodal approach: pain assessment (before the procedure, immediately after the procedure2, 12, 24, 48 hours, 1 week, 1 month, and 3-6 month after the procedure), regular medication for pain management (2 medications that working synergistically) and physiotherapy. Assessment (catastrophizing scale, pain intensity, neuropathic pain component - DN4 questionnaire) and treatment of site (limb) pain will be provided by pain physician or anaesthesiologist with more than 5 yr. experience. During the PCI procedure patient will get 1 g paracetamol intravenously, 6 hr after the procedure Ibuprofen 600mg/day orally will be given. Brief description of the physiotherapy. The patients will be trained one-on-one to exercises the limb. The beginning of the exercise only after 24-48 hr after the procedure. He will repeat exercise 2-3 times in the day for a week in home settings. Patient will get leaflet of the light exercises (please see attached file with pictures) of the upper limb. There is no heart rate target or etc. If the pain would persist patient will stop exercising and he will be assessed by pain physician for additional adjuvant treatment or further investigation. Pain assessment will be provided before the procedure, during the procedure and 2, 12, 24, 48 hours, 1 week, 1 month, and 3-6 month after the procedure. Other data associated with the PCI procedure or diseases will be collected.
Sponsors
Lithuanian University of Health Science
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (>= 18 yr. old) Patients with ischemic heart disease Heart failure class I-II (Killip/NYHA) Written consent No allergies or other known contraindications for pain relief medication use
Exclusion criteria
Patient’s refusing to participate in trial Heart failure class III-IV (Killip/NYHA) Liver, kidney or other known disease or allergies for medication that will be used Patients who used pain medication before the trial for other pain conditions Site Pain before the procedure Pregnancy/ Breast feeding
Outcome results
None listed