Fentanyl AnalgesiaFTNNCT00635986
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
A study testing Fentanyl in people with Fentanyl Analgesia, run by Federal University of São Paulo.
Trial summary
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fentanyl Analgesia
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Nov 2006
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs
Who cannot join
- Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids
About this study
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.
DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.
METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.
- Conditions
- Fentanyl Analgesia
- Being tested
- Fentanyl
- Keywords
- Analgesia, Fentanyl, Orthopedic, Mechanism of action, Surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
100 mcg Fentanyl intravenous or epidural route
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: 1 year
Secondary outcomes (1)
fentanyl plasma concentration measure in different times
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fentanyl AnalgesiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Adriana M Issy, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635986
- Sponsor's protocol ID
- Fentanyl
- Other IDs
- No grant
- Acronym
- FTN
- Status last verified
- Mar 2008
- First submitted
- 14 Jan 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Privado MS, Issy AM, Lanchote VL, Garcia JB, Sakata RK. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial. Sao Paulo Med J. 2010 Jan;128(1):5-9. doi: 10.1590/s1516-31802010000100002.
PubMed 20512273
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl
- ClinicalTrials.gov ID
- NCT00635986
- Acronym / sponsor ID
- FTN / Fentanyl
- Conditions
- Fentanyl Analgesia
- Keywords
- Analgesia, Fentanyl, Orthopedic, Mechanism of action, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jun 2005 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 14 Mar 2008 (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.
CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.
DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.
METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Fentanylgroup 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs
Key exclusion criteria (1 listed)
- Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids
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 |
|---|---|---|
| Fentanyl100 mcg Fentanyl intravenous or epidural route | Drug | A |
Primary outcome
Pain relief
Time frame: 1 year
1 secondary outcome
fentanyl plasma concentration measure in different times
Time frame: 1year
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 14 Mar 2008.
- Derived from this study: PubMed 20512273Privado MS, Issy AM, Lanchote VL, Garcia JB, Sakata RK. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial. Sao Paulo Med J. 2010 Jan;128(1):5-9. doi: 10.1590/s1516-31802010000100002.
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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.
Adriana M Issy, PhD study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Fentanyl Analgesia, run by Federal University of São Paulo.
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 1 inclusion and 1 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 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pain relief (time frame: 1 year). 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 NCT00635986, which also lists 1 linked publication.
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 14 Mar 2008.