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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02925364
Enrollment
17
Registered
2016-10-05
Start date
2016-09-30
Completion date
2020-01-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Other Functional Disturbances Following Cardiac Surgery

Keywords

magnetic resonance imaging, central pain processing, anatomical MRI, fMRI

Brief 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.

Interventions

RADIATIONmagnetic resonance imaging (MRI)

all participants will undergo a functional MRI and an anatomical MRI in a single session

Sponsors

Dr. Tarit Saha
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
functional MRI (fMRI)6 months postoperativelyfunctional MRI of brain stem & spinal cord

Secondary

MeasureTime frameDescription
anatomical MRI6 months postoperativelyanatomical MRI of neck & chest

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026