A Phase 4 interventional study of spine surgery in Pain, Postoperative, sponsored by Kuopio University Hospital. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Kuopio University Hospital · Phase 4, Interventional, and Treatment
Tramadol-paracetamol combination is studied in patients coming for elective spine surgery. The study drug is started at the day of surgery and continued maximum of five days. Before the surgery pain, use of pain medication, satisfaction for pain medication, adverse effects, resilience, depression and life satisfaction were asked. At the discharge and seven days after the surgery use of pain medication and adverse effects were asked. The patients were followed up to 28 days and one year after surgery.
5,227 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 120 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery
Procedure: spine surgery
Placebo two tablets twice daily up to five days for patients undergoing spinal surgery
Procedure: spine surgery
Tramadol-paracetamol 325mg/37,5mg two tablets twice daily
Satisfaction for pain medication
satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied
Time frame: one week after surgery
need for rescue pain medication
Measured as amount of other pain medicines used as rescue medicine
Time frame: one week after surgery
Pain assessment
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
Time frame: one week after surgery
adverse effects
Patient reported adverse reactions
Time frame: one week after surgery
Pain assessment
Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
Time frame: one year after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2020 (actual). Primary completion is estimated for Dec 2024, 58 months after the start.
Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 58 months is above that.
Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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