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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: 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: Narop Pharmaceutical Form: Solution for infusion INN or Proposed INN: ROPIVACAINE CAS Number: 84057954 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2‐ Trade Name: Marcain Pharmaceutical Form: Solution for infusion INN or Proposed INN: BUPIVACAINE CAS Number: 2180929 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Trade Name: Fentanyl B. Braun Pharmaceutical Form: Solution for infusion INN or Proposed INN: FENTANYL CAS Number: 437387 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 50‐ Trade Name: Adrenalin Merck NM Pharmaceutical Form: Solution for infusion INN or Proposed INN: EPINEPHRINE CAS Number: 51434 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ CONDITION: 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 PRIMARY OUTCOME: 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. 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 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. 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
Epistemonikos ID: 7a09f1a0367f9c8b84862622bf8e251039675d80
First added on: Aug 21, 2024