Tramadol-paracetamol in spine surgery
- Conditions
- Postoperative pain after spine surgeryMedDRA version: 20.0Level: LLTClassification code 10049130Term: Back surgerySystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2017-004711-39-FI
- Lead Sponsor
- Merja Kokki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 120
18-75-year old patient undergoing elective spine surgery
BMI 18-35 kg/m2
Participants must understand the meaning of the study, and the procedures, and provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
Age<18 years or >75 years
Hypersensitivity to ibuprofen, other non-steroidal anti-inflammatory drugs, paracetamol, tramadol or their exipients
Astma, urticaria or allergic reaction to ASA/NSAIDs
Acute bleeding or history if hemorrhage in gastrointestinal tract or peptic ulcer
Bleeding disorder
Use of nonoamineoxidase inhibitors within last two weeks
Severe hepatic impairment.
Epilepsy not controlled by treatment
Patients susceptible to seizures or taking other medications that lower the seizure threshold
Severe liver or renal failure
Severe respiratory impairment
Severe cardiac insufficiency
History or acute intoxication with alcohol, hypnotic medicinal products, centrally-acting analgesics, opioids or psychotropic medicinal products
Pregnancy or breastfeeding
Other reason investigator estimates prelude participation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method