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Sponsored by: |
Rambam Health Care Campus |
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Information provided by: | Rambam Health Care Campus |
ClinicalTrials.gov Identifier: | NCT00254631 |
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.
Condition | Intervention | Phase |
---|---|---|
Fractures |
Drug: Oxycodone hydrochloride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures |
Estimated Enrollment: | 80 |
Study Start Date: | April 2007 |
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.
Study Hypothesis:
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ruth Edery, MD | 972-57-7271905 | r_edery@rambam.health.gov.il |
Israel | |
RAMBAM Health Care Campus | Recruiting |
Haifa, Israel, 31096 | |
Contact: Ruth Edery, MD 972-2-50-2065873 r_edery@rambam.health.gov.il | |
Principal Investigator: Ruth Edery, MD |
Principal Investigator: | Ruth Edery, MD | Rambam Health Care Campus |
Study ID Numbers: | pre-oxy.CTIL |
Study First Received: | November 15, 2005 |
Last Updated: | April 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00254631 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
long bone fracture open fractures closed fractures trauma |
Oxycodone Fractures, Bone Wounds and Injuries |
Disorders of Environmental Origin Fractures, Open Fractures, Closed |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Narcotics |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Pharmacologic Actions |