Tramadol-paracetamol Combination in Treatment of Patients Undergoing Spinal Surgery

NCT04533009 | Unknown Phase 4

• 1 other identifier: 2017-11-10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Satisfaction for pain medication

  satisfaction measured with numeral rating scale 0-10 (0=not satisfied, 10= totally satisfied

  one week after surgery

Secondary Outcomes (3)

• need for rescue pain medication

  one week after surgery

• Pain assessment

  one week after surgery

• adverse effects

  one week after surgery

Other Outcomes (1)

• Pain assessment

  one year after surgery

Study Arms (2)

tramadol/acetaminophen

ACTIVE COMPARATOR

Tramadol-paracetamol two tablets 37,5mg/325mg twice daily up to five days for patients undergoing spinal surgery

Procedure: spine surgery

placebo

PLACEBO COMPARATOR

Placebo two tablets twice daily up to five days for patients undergoing spinal surgery

Procedure: spine surgery

Interventions

spine surgery PROCEDURE

Tramadol-paracetamol 325mg/37,5mg two tablets twice daily

placebo; tramadol/acetaminophen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years,
• BMI 18-35 kg/m2,
• informed consent obtained,
• elective spine surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• University of Eastern Finland: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Merja Kokki, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: placebo tablets are used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double blinded, placebo controlled study

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: August 31, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)