Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Pain, Postoperative Clinical Trial

— TRAMAPARAS  

Official title:

Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04533009
• Other study ID #: 2017-11-10
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age 18-75 years,

• BMI 18-35 kg/m2,

• informed consent obtained,

• elective spine surgery

Exclusion Criteria:

• Age<18 years or >75 years

• Hypersensitivity to anti-inflammatory drugs, paracetamol, tramadol or their auxiliary substances

• Acute or recovered hemorrhage in gastrointestinal tract or peptic ulcer

• Hemorrhagic disease

• Monoamineoxidase use in past two weeks

• Epilepsy

• Tendency to seizure

• Anti-seizure drugs in use Liver or renal failure Reduction in lung function Alcohol, drug or opioid addiction on record Acute intoxication due to alcohol, analgesics, opioids or psychopharmacon Pregnancy or breastfeeding Investigators estimation

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• spine surgery
Tramadol-paracetamol 325mg/37,5mg two tablets twice daily

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio	Northern Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain assessment	Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)	one year after surgery
Primary	Satisfaction for pain medication	satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied	one week after surgery
Secondary	need for rescue pain medication	Measured as amount of other pain medicines used as rescue medicine	one week after surgery
Secondary	Pain assessment	Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)	one week after surgery
Secondary	adverse effects	Patient reported adverse reactions	one week after surgery