Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

Phase 4

Active, not recruiting

• Conditions: Pain, Postoperative
• Interventions: Procedure: spine surgery

• Registration Number: NCT04533009
• Lead Sponsor: Kuopio University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-04
• Study Start: 2020-02-01
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tramadol/acetaminophen	spine surgery	Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery
placebo	spine surgery	Placebo two tablets twice daily up to five days for patients undergoing spinal surgery

Primary Outcome Measures

Name	Time	Method
Satisfaction for pain medication	one week after surgery	satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied

Secondary Outcome Measures

Name	Time	Method
need for rescue pain medication	one week after surgery	Measured as amount of other pain medicines used as rescue medicine
Pain assessment	one week after surgery	Pain measered in numeral rating scale 0-10 (0= no pain, 10=worst pain)
adverse effects	one week after surgery	Patient reported adverse reactions

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland