Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00254631
First received: November 15, 2005
Last updated: February 15, 2009
Last verified: February 2009
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • post operative pain scores during first 24 hours (Visual analog scale)

Secondary Outcome Measures:
  • Time to first analgesic request
  • Total other pain medications at first 24 hours post operative
  • Time to first oral intake
  • Length of hospitalization

Estimated Enrollment: 80
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254631

Locations
Israel
RAMBAM Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ruth Edery, MD Rambam Health Care Campus
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00254631     History of Changes
Other Study ID Numbers: pre-oxy.CTIL
Study First Received: November 15, 2005
Last Updated: February 15, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
long bone fracture
open fractures
closed fractures
trauma

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries
Oxycodone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on April 23, 2014