FracturesPhase 4NCT00254631
Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
A Phase 4 study testing Oxycodone hydrochloride in people with Fractures, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fractures
- What is being tested?
- Oxycodone hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Dec 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient consent.
- Age 18 years to 60 years.
- Isolated limb bone fracture/s.
Who cannot join
- Patient refusal.
- Age 61 years and older.
- Known allergy to study medication.
- Multiple bone fractures in different limbs.
- Multiple trauma.
- Oncological patients.
Show all 21Show fewer
- Respiratory depression / respiratory insufficiency / hypercarbia.
- Acute bronchial asthma.
- CNS depression / hallucinations.
- Alzheimer / dementia.
- Known convulsive disorder.
- Prostate hypertrophy.
- Paralytic ileus.
- Renal dysfunction (plasma creatinine > 1.5).
- Liver dysfunction.
- Adrenocortical insufficiency.
- Hypothyroidism.
- Pancreatitis.
- Pregnancy and lactating.
- Drug abuse, current or in the past.
- Alcohol abuse on admission to operating room.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fractures
- Being tested
- Oxycodone hydrochloride
- Keywords
- long bone fracture, open fractures, closed fractures, trauma
- Medical subject headings
- Fractures, Bone, Fractures, Open, Fractures, Closed, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | pre operative medication with 20 mg oxycontine PO Receives: Drug: Oxycodone hydrochloride |
| placebo group | Placebo comparator | pre operative medication with placebo tablet PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain scores during first 24 hours (Visual analog scale)
Measured: 24 hours after surgery
Secondary outcomes (4)
Time to first analgesic request
Measured: at PACU
Total other pain medications at first 24 hours post operative
Measured: first 24 hours after surgery
Time to first oral intake
Measured: first 24 hours after surgery
Length of hospitalization
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, edery, Rambam Health Care Campus
- Investigators
- Ruth Edery, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254631
- Sponsor's protocol ID
- pre-oxy.CTIL
- Status last verified
- Feb 2015
- First submitted
- 15 Nov 2005
- Last updated
- 5 Feb 2015
- Results posted
- No
Publications
Bach S, Noreng MF, Tjellden NU. Phantom limb pain in amputees during the first 12 months following limb amputation, after preoperative lumbar epidural blockade. Pain. 1988 Jun;33(3):297-301. doi: 10.1016/0304-3959(88)90288-6.
PubMed 3419837Code WE, Yip RW, Rooney ME, Browne PM, Hertz T. Preoperative naproxen sodium reduces postoperative pain following arthroscopic knee surgery. Can J Anaesth. 1994 Feb;41(2):98-101. doi: 10.1007/BF03009799.
PubMed 8131242Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
PubMed 8346839Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
PubMed 15728066
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia With OxyContin Versus Placebo Before Surgery for Long Bone Fractures
- ClinicalTrials.gov ID
- NCT00254631
- Acronym / sponsor ID
- pre-oxy.CTIL
- Conditions
- Fractures
- Keywords
- long bone fracture, open fractures, closed fractures, trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: Oxycodone hydrochloridepre operative medication with 20 mg oxycontine PO |
| placebo group | Placebo comparator | –pre operative medication with placebo tablet PO |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient consent.
- Age 18 years to 60 years.
- Isolated limb bone fracture/s.
Key exclusion criteria (21 listed)
- Patient refusal.
- Age 61 years and older.
- Known allergy to study medication.
- Multiple bone fractures in different limbs.
- Multiple trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone hydrochloride | Drug | study group |
Primary outcome
post operative pain scores during first 24 hours (Visual analog scale)
Time frame: 24 hours after surgery
4 secondary outcomes
Time to first analgesic request
Time frame: at PACU
Total other pain medications at first 24 hours post operative
Time frame: first 24 hours after surgery
Time to first oral intake
Time frame: first 24 hours after surgery
Length of hospitalization
Time frame: after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
- Background: PubMed 3419837Bach S, Noreng MF, Tjellden NU. Phantom limb pain in amputees during the first 12 months following limb amputation, after preoperative lumbar epidural blockade. Pain. 1988 Jun;33(3):297-301. doi: 10.1016/0304-3959(88)90288-6.
- Background: PubMed 8131242Code WE, Yip RW, Rooney ME, Browne PM, Hertz T. Preoperative naproxen sodium reduces postoperative pain following arthroscopic knee surgery. Can J Anaesth. 1994 Feb;41(2):98-101. doi: 10.1007/BF03009799.
- Background: PubMed 8346839Woolf CJ, Chong MS. Preemptive analgesia--treating postoperative pain by preventing the establishment of central sensitization. Anesth Analg. 1993 Aug;77(2):362-79. doi: 10.1213/00000539-199377020-00026. No abstract available.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 15728066Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth Edery, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone hydrochloride in people with Fractures, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain scores during first 24 hours (Visual analog scale) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254631, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.