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

Further study details as provided by Rambam Health Care Campus:

Primary Outcomes: post operative pain scores during first 24 hours (Visual analog scale)
Secondary Outcomes: Time to first analgesic request; Total other pain medications at first 24 hours post operative; Time to first oral intake; Length of hospitalization
Expected Total Enrollment:  80

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   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. Patient consent.
2. Age 18 years to 60 years.
3. Isolated limb bone fracture/s.

Exclusion Criteria:

1. Patient refusal.
2. Age 61 years and older.
3. Known allergy to study medication.
4. Multiple bone fractures in different limbs.
5. Multiple trauma.
6. Oncological patients.
7. Respiratory depression / respiratory insufficiency / hypercarbia.
8. Acute bronchial asthma.
9. CNS depression / hallucinations.
10. Alzheimer / dementia.
11. Known convulsive disorder.
12. Prostate hypertrophy.
13. Paralytic ileus.
14. Renal dysfunction (plasma creatinine > 1.5).
15. Liver dysfunction.
16. Adrenocortical insufficiency.
17. Hypothyroidism.
18. Pancreatitis.
19. Pregnancy and lactating.
20. Drug abuse, current or in the past.
21. Alcohol abuse on admission to operating room.

Please refer to this study by ClinicalTrials.gov identifier  NCT00254631

Ruth Edery, MD      972-57-7271905    r_edery@rambam.health.gov.il

Israel
      RAMBAM Health Care Campus, Haifa,  31096,  Israel

Study chairs or principal investigators

Ruth Edery, MD,  Principal Investigator,  Rambam Health Care Campus   

Study ID Numbers:  pre-oxy.CTIL
Last Updated:  December 8, 2005
Record first received:  November 15, 2005
ClinicalTrials.gov Identifier:  NCT00254631
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
ClinicalTrials.gov processed this record on 2006-01-10