Functional and Anatomical MRI of the Spinal Cord and Peri-spinal Tissues

Chronic Pain Clinical Trial

Official title:

Functional and Anatomical MRI of the Spinal Cord and Perispinal Tissues 6 Months After Cardiac Surgery With Standard vs. Gradual Sternal Retraction: Implications for Chronic Post-surgical Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02925364
• Other study ID #: ANAE-233-13-amendment
• Status: Terminated
• Start date: September 2016
• Est. completion date: January 2020

Study information

• Verified date: June 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The current study is an amendment to a previously approved blinded randomized controlled trial (NCT02697812) which examines the rate at which the sternal retraction maneuver is performed during cardiac surgery (standard over 30 seconds versus. gradual over 15 minutes) and examines the incidence of chronic post-sternotomy pain 6 months following surgery. Patients enrolled in the parent study will be identified at the 6 month follow-up and recruited in terms of whether they report chest pain. A total of 30 participants will be recruited (15 with and 15 with no pain) to undergo a single MRI session in which functional MRI will be done on the brain stem and spinal cord and anatomical MRI images will be collected for specific chest and neck structures. This will indicate whether there are long-term differences in pain processing and/or physical damage to neck and chest structures in those with and without chronic pain 6 months following coronary artery bypass graft surgery. All functional and anatomical MRI images will be reviewed and interpreted with study personnel blinded to whether the patient is reporting pain or no pain at their 6 month follow-up interview.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Elective Primary Coronary Artery Bypass Surgery
• Understanding and provision of written informed consent
• Age > 18 and < 75
• ASA class I, II or II Exclusion Criteria: Any combined or redo cardiac procedure
• Current alcohol or substance abuse
• Pre-existing chronic pain requiring chronic analgesic use
• Rest pain in proposed surgical area at baseline, preoperatively
• Chronic Steroid use
• Inability to perform post-operative assessments

Related Conditions & MeSH terms

• Chronic Pain
• Other Functional Disturbances Following Cardiac Surgery

Intervention

Radiation:
• magnetic resonance imaging (MRI)
all participants will undergo a functional MRI and an anatomical MRI in a single session

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Tarit Saha

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional MRI (fMRI)	functional MRI of brain stem & spinal cord	6 months postoperatively
Secondary	anatomical MRI	anatomical MRI of neck & chest	6 months postoperatively