Postoperative Pain Clinical Trial
— IPAST-CRANIOOfficial title:
Evaluation of Patient Stress Level Caused by Radiological Investigations in Early Postoperative Phase After Craniotomy (IPAST-CRANIO): Protocol of a Swiss Prospective Cohort Study
Verified date | November 2023 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Postoperative imaging after neurosurgical intervention is usually performed in the first 72 hours after surgery. Postoperative radiological examinations in the first 72 hours provide accurate assessment of postoperative resection status. On the other side is frequently reported by patients that the earlier postoperative examinations after craniotomy for tumor and vascular procedures are associated with distress, exertion, nausea, and pain. Therefore, psychological and physical stress on the patient could be a potential disadvantage of earlier (up to 36 hours postoperatively) follow-up. The goal of this study is to evaluate and determine the optimal time frame for postoperative imaging with MRI and CT in terms of medical and neuroradiological implications and patient's subjective stress. The primary endpoint of the study is the extent of subjective distress due to postoperative MRI and CT monitoring in relation to the time interval after surgery Data will be prospectively collected from all patients aged 18 to 80 years who receive postoperative MRI or CT follow-up after craniotomy for resection of a cerebral tumor (benign and malignant) or vascular surgery. This study determines, whether a timing of postoperative imaging can improve patient satisfaction and reduce pain, stress and discomfort caused by postoperative imaging. The outcome corresponds to the value-based medicine approach of modern patient-centred medicine. Results will be published in peer-reviewed journals and electronic patient data will be safely stored for 15 years.
Status | Terminated |
Enrollment | 152 |
Est. completion date | February 1, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Written consent of the patient - Age between 18 and 80 years - Planned for supra- or infratentorial (partial) resection of space occupying lesion (benign or malignant) or vascular neurosurgical procedure (clipping of an aneurysm, resection of an arteriovenous malformation, resection of cavernoma) - Patients planned for MRI or CT follow-up within 72 hours after surgery Exclusion Criteria: - No informed consent - Operation using only one burr hole (e.g. biopsy) - Not able to fill out the questionnaires due to cognitive impairment or aphasia - Not understanding German or English language - Contraindication for MRI examination - No postoperative MRI or CT examination planned within 72 hours after surgery |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Neurosurgery, University Hospital Zurich | Zürich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Tosic L, Thoma M, Voglis S, Hofer AS, Bektas D, Pangalu A, Regli L, Germans MR. Evaluation of patient STress level caused by radiological Investigations in early Postoperative phase After CRANIOtomy (IPAST-CRANIO): protocol of a Swiss prospective cohort study. BMJ Open. 2022 Sep 21;12(9):e061452. doi: 10.1136/bmjopen-2022-061452. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary endpoint of the study is the difference in subjective distress after craniotomy, measured just before and after postoperative MRI or CT. | Subjective distress is evaluated as a combination of the results of the 3 scores: visual analogue scale for (VAS) pain, VAS for nausea and Body Part Discomfort score. | The measurements are taken up to 1 hour before and up to 1 hour after postoperative radiological imaging after craniotomy. | |
Secondary | Patient specific secondary endpoint | Patient subjective interpretation of whether MRI control was performed at the correct interval. At the end of the questionnaire, patients will be asked to answer the following question:
In your opinion, should the MRI and/or CT scan have been performed earlier or later? The possible answers are: Yes, earlier; Yes, later; No, I am satisfied with the timing of the exam. |
The measurement is taken up to 1 hour after postoperative radiological imaging after craniotomy. | |
Secondary | Radiology specific secondary endpoints | Presence of residual tumor on MRI: yes or no. Presence of contrast enhancement on MRI (postoperative reactive change, not tumor specific): yes or no.
Presence of post-operative bleeding on CT or MRI: yes or no. Presence of postop-operative infarction on MRI: yes or no Residual perfusion of the aneurysm or AVM remnant on MRI or CT: yes or no. |
The radiological evaluation of imaging after craniotomy is performed up to 12 hours after postoperative radiological examination. |
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