Postoperative PainPhase 4NCT02090790
Comparison of Analgesic Consumption Between Perioperative ıv Dexamethasone and Added to Femoral Block
A Phase 4 study testing iv dexamethasone, femoral dexamethasone and serum physiologic in people with Postoperative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- iv dexamethasone, femoral dexamethasone and serum physiologic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Jul 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18-65 age
- knee arthroplasty
- no known allergies to drugs
- ASA 1-2 patients
Who cannot join
- history of diabetes
- history of chronic pain treatment
- pregnancy
- severe bronchopulmonary disease
- systemic opioid and steroid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes Univercity Hospital
Kayseri, 38039
ahmet öner, resident, +905059504112, dr_ahmetoner@hotmail.com
gülen güler, prof, +905327922484, gulen@erciyes.edu.tr
About this study
Official title: The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients
the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients
Read the detailed description
Total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used.
Dexamethasone is a glucocorticoid of high potency and frequently used perioperative.Dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.If the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.
- Conditions
- Postoperative Pain
- Being tested
- iv dexamethasone, femoral dexamethasone, serum physiologic
- Keywords
- dexamethasone, femoral block, total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv dexamethasoneDrug
Also called decort
2 ml 8 mg iv dexamethasone
femoral dexamethasoneDrug
Also called dekort
2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain
serum physiologicDrug
2 ml iv serum physiologic
| Study group | Role | What they receive |
|---|---|---|
| iv dexamethasone | Active comparator | perioperative 2ml 8 mg ıv dexamethasone Receives: Drug: iv dexamethasone |
| femoral dexamethasone | Active comparator | femoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone Receives: Drug: femoral dexamethasone |
| serum physiologic | Placebo comparator | Not described Receives: Drug: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Measured: postoperative 2 day
Secondary outcomes (1)
analgesic consumption
morphine consumption (patient controlled analgesia procedure)
Measured: postoperative 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmet öner, TC Erciyes University
- Investigators
- ahmet öner, recident, Principal investigator, erciyes univercitygülen güler, prof, Study director, erciyes univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090790
- Sponsor's protocol ID
- 2013/400
- Status last verified
- Mar 2014
- First submitted
- 17 Mar 2014
- Last updated
- 21 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients
- ClinicalTrials.gov ID
- NCT02090790
- Acronym / sponsor ID
- 2013/400
- Conditions
- Postoperative Pain
- Keywords
- dexamethasone, femoral block, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 18 Mar 2014 (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.
the aim of this study was to investigate compare the effect of peroperative intravenous single dose dexamethasone and the addition of dexamethasone to femoral nerve block on postoperative analgesic consumption and patient comfort in unilateral total knee arthroplasty patients
Detailed description
Total knee arthroplasty leads to severe postoperative pain. for postoperative pain control after total knee arthroplasty oral -intramuscular opioids ,patient controlled analgesia intravenous or epidural opioids, single -continuous femoral nerve block involving techniques are used.
Dexamethasone is a glucocorticoid of high potency and frequently used perioperative.Dexamethasone to the local anaesthetic solution administered trough in femoral nerve blocks significantly prolonged the analgesic effect of the local anaesthetics used on this blocks.If the analgesic efficacy of systemic treatment with dexamethasone is similar with the use of perineural wich is the safest way should be preferred for systemic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| iv dexamethasone | Active comparator | Drug: iv dexamethasoneperioperative 2ml 8 mg ıv dexamethasone |
| femoral dexamethasone | Active comparator | Drug: femoral dexamethasonefemoral block was performed postoperative 30 ml 0,5 % bupivacaine added 2 ml 8 mg dexamethasone |
| serum physiologic | Placebo comparator | Drug: serum physiologic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18-65 age
- knee arthroplasty
- no known allergies to drugs
- ASA 1-2 patients
Key exclusion criteria (5 listed)
- history of diabetes
- history of chronic pain treatment
- pregnancy
- severe bronchopulmonary disease
- systemic opioid and steroid use
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 |
|---|---|---|
| iv dexamethasoneAlso: decort2 ml 8 mg iv dexamethasone | Drug | iv dexamethasone |
| femoral dexamethasoneAlso: dekort2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain | Drug | femoral dexamethasone |
| serum physiologic2 ml iv serum physiologic | Drug | serum physiologic |
Primary outcome
visual analog scale
Time frame: postoperative 2 day
1 secondary outcome
analgesic consumption
Time frame: postoperative 2 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2014.
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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.
ahmet öner, recident principal investigator
erciyes univercity
gülen güler, prof study director
erciyes univercity
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 iv dexamethasone, femoral dexamethasone and serum physiologic in people with Postoperative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2014. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmet öner, resident (+9055059504112, dr_ahmetoner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: postoperative 2 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2014.