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Postoperative epidural analgesia with Breivik's mixture (bupivacain, fentanyl, epinephrine) compared to Narop (rupivacain) combined with oral oxycodon after posterior lumbar fusion. - Breivik vs. Narop

Postoperative epidural analgesia with Breivik's mixture (bupivacain, fentanyl, epinephrine) compared to Narop (rupivacain) combined with oral oxycodon after posterior lumbar fusion. - Breivik vs. Narop

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001417-41-SE
Enrollment
Unknown
Registered
2007-06-15
Start date
2007-08-10
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Postoperative analgesia in patients undergoing spine surgery, mainly spinal fusions in the lumbar spine. MedDRA version: 9.1 Level: LLT Classification code 10050505 Term: Spinal fusion surgery

Interventions

Trade Name: OxyContin Pharmaceutical Form: Tablet INN or Proposed INN: OXYCODONE CAS Number: 76426 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name:

Sponsors

Stockholm Spine Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients should undergo one or two levels fusion in lumbar spine. 2. Patients should have an epidural catheter in. 3. Patients should be 18-70 years. 4. Patients should read and comprehend Swedish and be willing to sign 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to any of the study drugs. 2. Patients with continously oral treatment with any strong opioid at the time of premedication.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate if postoperative epidural analgesia with rupivacain combined with oral oxycodone gives fewer side effects in terms of pruritus than epidural analgesia with Breiviks mixture after spine surgery.;Secondary Objective: To evaluate if postoperative epidural analgesia with rupivacain combined with oral oxycodone gives fewer side effects in terms of motor paresis and pain breakthrough than epidural analgesia with Breiviks mixture and still provides satisfactory pain relief after spine surgery.;Primary end point(s): Pruritus will be measured according to following scale: 0 - no pruritus 1 - mild pruritus, no treatment needed 2 - severe pruritus, treatment needed 3 - very severe pruritus, epidural treatment is interrupted—

Countries

Sweden

Outcome results

None listed

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