Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
We would like to check whether pre-operative administration of an oral controlled-release opioid formulation (Oxycodone hydrochloride (OxyContin)) could result in a clear effect of preemptive analgesia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures|
- post operative pain scores during first 24 hours (Visual analog scale) [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
- Time to first analgesic request [ Time Frame: at PACU ] [ Designated as safety issue: No ]
- Total other pain medications at first 24 hours post operative [ Time Frame: first 24 hours after surgery ] [ Designated as safety issue: No ]
- Time to first oral intake [ Time Frame: first 24 hours after surgery ] [ Designated as safety issue: No ]
- Length of hospitalization [ Time Frame: after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: study group
pre operative medication with 20 mg oxycontine PO
|Drug: Oxycodone hydrochloride|
Placebo Comparator: placebo group
pre operative medication with placebo tablet PO
Preemptive analgesia is based on the concept of treating pain before inflicting the painful stimulus. One suggested mechanism is that transmission of pain signals is altered when the patient is treated before infliction of noxious stimulation. That prevents changes from happening in the nervous system, making transformation from acute to chronic pain ("central sensitization") less likely, and thus reducing post operative pain.
Clinically, good post operative pain control has been shown to be an effective method for hastening patient convalescence and discharge. It makes part of a general approach aiming to accelerate surgical recovery through earlier enteric feeding and ambulation
OxyContin tablets deliver Oxycodone at a controlled release manner, over 12 hours. After oral administration oral bioavailability is 60-87%.
A biphasic absorption pattern is observed, describing the initial (0.6 hours) and prolonged (6.9 hours) release of Oxycodone from the OxyContin tablets. Clinical analgesia is observed within 1 hour of administration.
We believe that this mode of oral drug release is more appropriate for the perioperative pain treatment of patients undergoing short to medium term operations: with timely administration, the first absorbed part of the drug reaches the plasma before infliction of the noxious stimuli, possibly counteracting primary sensitization, and the second part absorbed, acts on post operative ongoing pain, possibly counteracting more advanced stages of neuronal plasticity.
Our hypothesis is that post operative pain will be lowered by pre-operative administration of OxyContin. When comparing the two groups we will look for differences in observed parameters, especially VAS numbers, time to first analgesic request, post operative analgesic requirements, time to first oral intake and length of hospitalization, to confirm or deny our hypothesis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254631
|RAMBAM Health Care Campus|
|Haifa, Israel, 31096|
|Principal Investigator:||Ruth Edery, MD||Rambam Health Care Campus|