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Trial registered on ANZCTR


Registration number
ACTRN12618001699257
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
15/10/2018
Date last updated
31/03/2021
Date data sharing statement initially provided
31/03/2021
Date results information initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Site pain after Percutaneous Coronary Intervention in patients with Ischemic Heart Diseases.
Scientific title
The Impact of Multi-modal Pain Management on the development of site Acute and Chronic Pain, Outcomes, Quality of Life in Patients with Ischemic Heart Disease (IHD) following Percutaneous Coronary Intervention (PCI).
Secondary ID [1] 296247 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic heart disease 309903 0
Acute site limb pain after PCI 309905 0
Chronic Pain 309906 0
Condition category
Condition code
Anaesthesiology 308687 308687 0 0
Pain management
Cardiovascular 308688 308688 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312575 0
Prevention
Intervention code [2] 312576 0
Treatment: Other
Comparator / control treatment
Control group will get pain relief in "as needed" regime and it will be provided by cardiologist who is taking care of the patient according to local pain management practice. For pain management after PCI will be used ketoprofen intravenously "as needed" up to maximal dose of the day, if the pain persists weak (tramadol 50 mg orally or intramuscular) or strong opioids (morphine orally or intramuscularly) only in "as needed" regime would be chosen. Maximum daily dose of tramadol 200mg, morphine 10 mg intramuscular and 30 mg orally.
Control group
Active

Outcomes
Primary outcome [1] 307659 0
Acute pain of site pain (upper limb) using Number Pain Scale

Timepoint [1] 307659 0
1 month after randomization
Primary outcome [2] 307698 0
Change in opioids use. It will be calculated morphine equivalent fined in medication diary.
Timepoint [2] 307698 0
one month after randomisation
Primary outcome [3] 307699 0
Patients satisfaction questionnaire short form (PSQ-18)
Timepoint [3] 307699 0
1 week after randomisation
Secondary outcome [1] 352508 0
Chronic pain. It will be assessed by Number Pain Scale
Timepoint [1] 352508 0
6 months after randomization
Secondary outcome [2] 352569 0
Quality of life as assessed using the SF-36
Timepoint [2] 352569 0
6 month after randomisation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20895 0
Lithuania
State/province [1] 20895 0
Kaunas

Funding & Sponsors
Funding source category [1] 300844 0
University
Name [1] 300844 0
Lithuanian University of Health Science
Address [1] 300844 0
A. Mickeviciaus street No 9,
LT-44307 Kaunas
Country [1] 300844 0
Lithuania
Primary sponsor type
University
Name
Lithuanian University of Health Science
Address
A. Mickeviciaus street No 9,
LT-44307 Kaunas
Country
Lithuania
Secondary sponsor category [1] 300392 0
Hospital
Name [1] 300392 0
Hospital of Lithuanian University of Health Science Kaunas Clinics
Address [1] 300392 0
Eiveniu street No 2
50009
Kaunas
Country [1] 300392 0
Lithuania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301612 0
Lithuanian Bioethics Committee ( Kaunas Region)
Ethics committee address [1] 301612 0
A. Mickeviciaus street No 9, LT- 44307
Ethics committee country [1] 301612 0
Lithuania
Date submitted for ethics approval [1] 301612 0
21/12/2017
Approval date [1] 301612 0
26/02/2018
Ethics approval number [1] 301612 0
BE-2-7

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3134 3134 0 0
/AnzctrAttachments/376124-Bioethics.pdf (Ethics approval)
Attachments [2] 3153 3153 0 0

Contacts
Principal investigator
Name 87554 0
Prof Andrius Macas
Address 87554 0
LSMUL Kauno klinikos, Anesteziologijos klinika, Eiveniu 2, LT-50161, Kaunas.

Country 87554 0
Lithuania
Phone 87554 0
+37037326221
Fax 87554 0
Email 87554 0
anesteziologijosklinika@kaunoklinikos.lt
Contact person for public queries
Name 87555 0
Mrs Liuda Brogiene
Address 87555 0
Eiveniu street 2, LT-50161, Kaunas, Anesthesiology Department, Pain Clinic


Country 87555 0
Lithuania
Phone 87555 0
37067762959
Fax 87555 0
Email 87555 0
liuda.brogiene@kaunoklinikos.lt
Contact person for scientific queries
Name 87556 0
Mrs Liuda Brogiene
Address 87556 0
Eiveniu street 2, LT-50161, Kaunas, Anesthesiology Department, Pain Clinic
Country 87556 0
Lithuania
Phone 87556 0
37067762959
Fax 87556 0
Email 87556 0
liuda.brogiene@kaunoklinikos.lt

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification. Data will be shared in accordance with the procedure established by the laws of the Republic of Lithuania and the Law on the Legal Protection of Personal Data.
When will data be available (start and end dates)?
There is no term of data sharing
Available to whom?
To Anyone who wishes to access the Data and declares interest of the data to the Lithuanian University of Health and Science and to the Hospital of Lithuanian University of Health and Science.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Lithuanian University of Health and Science
A. Mickeviciaus treet 9, Kaunas 44307, Lithuania
Phone.: +370 37 327200, Fax.: +370 37 220733, E-mail: rektoratas@lsmuni.lt.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary