Postoperative PainPhase 4(PAL)NCT02255955
Postoperative Analgesia in Laminectomy
A Phase 4 study testing 550 mg naproxen sodium and 30mg codeine and 300 mg paracetamol and 30 mg codeine in people with Postoperative Pain and Postoperative Laminectomy Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital.
Trial summary
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Postoperative Pain, Postoperative Laminectomy Pain
- What is being tested?
- 550 mg naproxen sodium and 30mg codeine and 300 mg paracetamol and 30 mg codeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery
Who cannot join
- were known allergies to any of the drugs used in this study
- peptic ulcer disease
- hepatic and renal dysfunction,
- emergency surgery
- inability to provide informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.
Read the detailed description
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.
- Conditions
- Postoperative Pain, Postoperative Laminectomy Pain
- Being tested
- 550 mg naproxen sodium and 30mg codeine, 300 mg paracetamol and 30 mg codeine, placebo tablet
- Keywords
- naproxen sodium codeine, paracetamol codeine, disk surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
550 mg naproxen sodium and 30mg codeineDrug
Also called Apranax plus
Postoperative contramal consumption, pain intensity, side effects
300 mg paracetamol and 30 mg codeineDrug
Also called geralgine K
Postoperative contramal consumption, pain intensity, side effects
placebo tabletDrug
Postoperative contramal consumption, pain intensity, side effects
| Study group | Role | What they receive |
|---|---|---|
| 550 mg naproxen sodium and 30mg codeine | Experimental | Preoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. Receives: Drug: 550 mg naproxen sodium and 30mg codeine |
| 300 mg paracetamol and 30 mg codeine | Active comparator | Preoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. Receives: Drug: 300 mg paracetamol and 30 mg codeine |
| Placebo | Placebo comparator | Preoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. Receives: Drug: placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contramal consumption
To assess contramal consumption
Measured: Postoperative 24 hour
Secondary outcomes (2)
Side effects
nausea and vomiting
Measured: postoperative 24 hour
Pain intensity
To assess postoperative pain intensity by visual analog scale
Measured: postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 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.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reyhan Polat, Diskapi Yildirim Beyazit Education and Research Hospital
- Investigators
- Reyhan Polat, MD, Principal investigator, Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255955
- Sponsor's protocol ID
- Pstoperative pain
- Acronym
- (PAL)
- Status last verified
- Dec 2014
- First submitted
- 27 Sep 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Naproxen Sodium + Codeine, and Paracetamol+ Codeine on Postoperative Laminectomy Pain
- ClinicalTrials.gov ID
- NCT02255955
- Acronym / sponsor ID
- (PAL) / Pstoperative pain
- Conditions
- Postoperative Pain, Postoperative Laminectomy Pain
- Keywords
- naproxen sodium codeine, paracetamol codeine, disk surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 3 Oct 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.
Compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (Contramal) consumption during the first 24 hour after a lumbar disk surgery.
Detailed description
Compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 550 mg naproxen sodium and 30mg codeine | Experimental | Drug: 550 mg naproxen sodium and 30mg codeinePreoperatively patients received oral naproxen sodium codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
| 300 mg paracetamol and 30 mg codeine | Active comparator | Drug: 300 mg paracetamol and 30 mg codeinePreoperatively patients received oral paracetamol codeine, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
| Placebo | Placebo comparator | Drug: placebo tabletPreoperatively patients received oral placebo tablet, postop contramal infused by PCA, and postoperative contramal consumption, side effects pain intensity measured by VAS. |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) 1 or 2 status patients scheduled for an elective lumbar disc surgery
Key exclusion criteria (5 listed)
- were known allergies to any of the drugs used in this study
- peptic ulcer disease
- hepatic and renal dysfunction,
- emergency surgery
- inability to provide informed consent
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 |
|---|---|---|
| 550 mg naproxen sodium and 30mg codeineAlso: Apranax plusPostoperative contramal consumption, pain intensity, side effects | Drug | 550 mg naproxen sodium and 30mg codeine |
| 300 mg paracetamol and 30 mg codeineAlso: geralgine KPostoperative contramal consumption, pain intensity, side effects | Drug | 300 mg paracetamol and 30 mg codeine |
| placebo tabletPostoperative contramal consumption, pain intensity, side effects | Drug | Placebo |
Primary outcome
Contramal consumption
Time frame: Postoperative 24 hour
To assess contramal consumption
2 secondary outcomes
Side effects
Time frame: postoperative 24 hour
Pain intensity
Time frame: postoperative 24 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 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.
Reyhan Polat, MD principal investigator
Ministry of Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 550 mg naproxen sodium and 30mg codeine and 300 mg paracetamol and 30 mg codeine in people with Postoperative Pain and Postoperative Laminectomy Pain, run by Diskapi Yildirim Beyazit Education and Research Hospital.
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 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 30 Dec 2014. 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. 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 Reyhan Polat, MD (+905326734310, reyhanp9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contramal consumption (time frame: Postoperative 24 hour). 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 30 Dec 2014.