Tramadol-paracetamol in spine surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004711-39-FI

Enrollment

120

Registered

2018-03-09

Start date

2018-04-10

Completion date

Unknown

Last updated

2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain after spine surgery MedDRA version: 20.0 Level: LLT Classification code 10049130 Term: Back surgery System Organ Class: 100000004865

Interventions

Trade Name: TRAMPALGIN Pharmaceutical Form: Tablet INN or Proposed INN: TRAMADOL HYDROCHLORIDE Other descriptive name: TRAMADOL HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Age75 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

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Patient's decision or investigator's concern of patient's safety;Timepoint(s) of evaluation of this end point: Not applicable	—

Primary

Measure	Time frame
Main Objective: To evalaute the patient satisfaction on analgesia efficacy of tramadol-paracetamol combination product for postoperative pain management in spine surgery;Secondary Objective: Need for rescue analgesia and the amount of pain during the first postoperative week, adverse effects, pain and need for analgesigs at 12 months after surgery;Primary end point(s): The participants will use tramadol-paracetamol or placebo as long as their postoperative pain is moderate ot severe, on a numeric rating scale at rest 3/10 or higher and/or dynamic pain 5/10 or higher. The drugs will be used up to 5 days. A maximum of 20 tablets. After that the patients will be treated according to their clinical status. The study continues as a survey.;Timepoint(s) of evaluation of this end point: The last questionnaire will be filled an year after the operation.	—

Measure

Time frame

Main Objective: To evalaute the patient satisfaction on analgesia efficacy of tramadol-paracetamol combination product for postoperative pain management in spine surgery;Secondary Objective: Need for rescue analgesia and the amount of pain during the first postoperative week, adverse effects, pain and need for analgesigs at 12 months after surgery;Primary end point(s): The participants will use tramadol-paracetamol or placebo as long as their postoperative pain is moderate ot severe, on a numeric rating scale at rest 3/10 or higher and/or dynamic pain 5/10 or higher. The drugs will be used up to 5 days. A maximum of 20 tablets. After that the patients will be treated according to their clinical status. The study continues as a survey.;Timepoint(s) of evaluation of this end point: The last questionnaire will be filled an year after the operation.

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Countries

Finland

Contacts

Public ContactKuopio University Hospital

Kuopio University Hospital

merja.kokki@kuh.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026