Postoperative PainPhase 4NCT02160236
Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam
A Phase 4 study testing dexketoprofen trometamol, tenoxicam and serum physiologic in people with Postoperative Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery. 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?
- dexketoprofen trometamol, tenoxicam and serum physiologic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to Feb 2015
- 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
- ASA 1-2
- between 18-65 age
- elective lumbar disc surgery
Who cannot join
- history of gastrointestinal bleeding
- peptic ulcer disease
- bleeding disorders
- history of allergic reactions to NSAİDs
- chronic pain syndrome
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes Universty Hospital
Kayseri, 38039
nazife küçük, resident, +905072317446, nzfkucuk@hotmail.com
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery
In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.
Read the detailed description
Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects
- Conditions
- Postoperative Pain
- Being tested
- dexketoprofen trometamol, tenoxicam, serum physiologic
- Keywords
- dexketoprofen trometamol, tenoxicam, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexketoprofen trometamolDrug
Also called arveles
before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
tenoxicamDrug
Also called oksamen
before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
serum physiologicDrug
before end of the surgery via administration intravenous 0.9 % NaCl 100 cc
| Study group | Role | What they receive |
|---|---|---|
| dexketoprofen trometamol | Active comparator | before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc Receives: Drug: dexketoprofen trometamol |
| tenoxicam | Active comparator | before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc Receives: Drug: tenoxicam |
| serum physiologic | Placebo comparator | before end of the surgery via administration intravenous 0.9 % NaCl 100 cc Receives: Drug: serum physiologic |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic consumption
morphine consumption (patient control analgesia procedure) was recorded
Measured: postoperative 1 day
Secondary outcomes (1)
visual analog scale
visual analog scale on rest and movement was recorded
Measured: postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startNov 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Küçük, TC Erciyes University
- Investigators
- nazife küçük, resident, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160236
- Sponsor's protocol ID
- 2013/469
- Status last verified
- Nov 2014
- First submitted
- 8 Jun 2014
- Last updated
- 10 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT02160236
- Acronym / sponsor ID
- 2013/469
- Conditions
- Postoperative Pain
- Keywords
- dexketoprofen trometamol, tenoxicam, postoperative pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 10 Jun 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.
In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.
Detailed description
Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects
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 |
|---|---|---|
| dexketoprofen trometamol | Active comparator | Drug: dexketoprofen trometamolbefore end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc |
| tenoxicam | Active comparator | Drug: tenoxicambefore the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc |
| serum physiologic | Placebo comparator | Drug: serum physiologicbefore end of the surgery via administration intravenous 0.9 % NaCl 100 cc |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-2
- between 18-65 age
- elective lumbar disc surgery
Key exclusion criteria (5 listed)
- history of gastrointestinal bleeding
- peptic ulcer disease
- bleeding disorders
- history of allergic reactions to NSAİDs
- chronic pain syndrome
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 |
|---|---|---|
| dexketoprofen trometamolAlso: arvelesbefore end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc | Drug | dexketoprofen trometamol |
| tenoxicamAlso: oksamenbefore the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc | Drug | tenoxicam |
| serum physiologicbefore end of the surgery via administration intravenous 0.9 % NaCl 100 cc | Drug | serum physiologic |
Primary outcome
analgesic consumption
Time frame: postoperative 1 day
morphine consumption (patient control analgesia procedure) was recorded
1 secondary outcome
visual analog scale
Time frame: postoperative 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 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.
nazife küçük, resident principal investigator
TC Erciyes University
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 dexketoprofen trometamol, tenoxicam 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 3 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 10 Nov 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 Nazife Küçük, resident (+905072317446, nzfkucuk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesic consumption (time frame: postoperative 1 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 10 Nov 2014.