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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254631
Recruitment Status : Completed
First Posted : November 16, 2005
Last Update Posted : February 5, 2015
Information provided by (Responsible Party):
edery, Rambam Health Care Campus

Brief Summary:
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 or disease Intervention/treatment Phase
Fractures Drug: Oxycodone hydrochloride Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. post operative pain scores during first 24 hours (Visual analog scale) [ Time Frame: 24 hours after surgery ]

Secondary Outcome Measures :
  1. Time to first analgesic request [ Time Frame: at PACU ]
  2. Total other pain medications at first 24 hours post operative [ Time Frame: first 24 hours after surgery ]
  3. Time to first oral intake [ Time Frame: first 24 hours after surgery ]
  4. Length of hospitalization [ Time Frame: after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254631

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

Responsible Party: edery, Rambam Health Care Campus Identifier: NCT00254631     History of Changes
Other Study ID Numbers: pre-oxy.CTIL
First Posted: November 16, 2005    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

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

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