Arthroscopic Meniscus SurgeryPhase 4NCT01952652
Naproxen Codeine in Arthroscopic Surgery
A Phase 4 study testing Group N:Naproxen sodium and Group NC :naproxen sodium codeine phosphate in people with Arthroscopic Meniscus Surgery, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthroscopic Meniscus Surgery
- What is being tested?
- Group N:Naproxen sodium and Group NC :naproxen sodium codeine phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Jul 2013
- 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
- Patients undergoing arthroscopic meniscectomy were included in the study.
Who cannot join
- ≤ 18 years of age
- hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
- history of peptic ulcer, gastritis, upper gastrointestinal bleeding
- coagulation disorder
- serious hepatic and renal impairment
- pregnancy
- long-term NSAID and opioid use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University School of Medicine Adana Teaching and Research Hospital
Adana, 01250
About this study
Official title: Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery
In this study, the aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.
Read the detailed description
Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.
- Conditions
- Arthroscopic Meniscus Surgery
- Being tested
- Group N:Naproxen sodium, Group NC :naproxen sodium codeine phosphate
- Keywords
- Naproxen-codeine, preemptive analgesia, day case surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group N:Naproxen sodiumDrug
Also called Apranax fort tb, Abdi Ibrahim Ilaç,Turkiye
drug will be given 60 minutes before surgery
Group NC :naproxen sodium codeine phosphateDrug
Also called Apranax plus tb, Abdi Ibrahim Ilac, Turkey
drug will be given 60 minutes before surgery
| Study group | Role | What they receive |
|---|---|---|
| Group Naproxen sodium (Group N) | Active comparator | Group N received naproxen sodium 550 mg 60 minutes before surgery. Receives: Drug: Group N:Naproxen sodium |
| Group Naproxen sodium codeine phosphate (Group NC) | Active comparator | Group NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery. Receives: Drug: Group NC :naproxen sodium codeine phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
patients will be followed postoperatively 18 hours for pain levels
Measured: postoperative 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Meniscus SurgeryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAGLA BALI,MD, Baskent University
- Investigators
- Anis Aribogan, Prof.,MD, Study director, Baskent University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952652
- Sponsor's protocol ID
- KA12/268
- Status last verified
- Sep 2013
- First submitted
- 20 Sep 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Analgesic Effects of Naproxen Sodium and Naproxen Sodium-codeine Phosphate Administered Preemptively for Arthroscopic Meniscus Surgery
- ClinicalTrials.gov ID
- NCT01952652
- Acronym / sponsor ID
- KA12/268
- Conditions
- Arthroscopic Meniscus Surgery
- Keywords
- Naproxen-codeine, preemptive analgesia, day case surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Sep 2013 (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 aim is to compare the efficacy of single dose naproxen sodium and combination of naproxen sodium-codeine phosphate on post-operative pain in adult patients undergoing arthroscopic menisectomy.Pre-emptive oral naproxen-codeine may be safely and more advantageous than naproxen alone.
Detailed description
Patients receiving preemptive oral naproxen sodium (Group N) or naproxen sodium-codeine phosphate (Group NC) were assigned in 2 groups.Preoperatively, drugs were given orally by a nurse unaware of the study to both groups within 60 minutes before surgery. Hemodynamic datas, possible side effects, pain and sedation levels of patients were recorded. Patient's pain and sedation levels were statistically assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Naproxen sodium (Group N) | Active comparator | Drug: Group N:Naproxen sodiumGroup N received naproxen sodium 550 mg 60 minutes before surgery. |
| Group Naproxen sodium codeine phosphate (Group NC) | Active comparator | Drug: Group NC :naproxen sodium codeine phosphateGroup NC received naproxen sodium 550 mg+30 mg codeine 60 minutes before surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing arthroscopic meniscectomy were included in the study.
Key exclusion criteria (7 listed)
- ≤ 18 years of age
- hypersensitivity to non-steroidal anti-inflammatory drugs and codeine,
- history of peptic ulcer, gastritis, upper gastrointestinal bleeding
- coagulation disorder
- serious hepatic and renal impairment
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 |
|---|---|---|
| Group N:Naproxen sodiumAlso: Apranax fort tb, Abdi Ibrahim Ilaç,Turkiyedrug will be given 60 minutes before surgery | Drug | Group Naproxen sodium (Group N) |
| Group NC :naproxen sodium codeine phosphateAlso: Apranax plus tb, Abdi Ibrahim Ilac, Turkeydrug will be given 60 minutes before surgery | Drug | Group Naproxen sodium codeine phosphate (Group NC) |
Primary outcome
Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery.
Time frame: postoperative 18 hours
patients will be followed postoperatively 18 hours for pain levels
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 30 Sep 2013.
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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.
Anis Aribogan, Prof.,MD study director
Baskent University School of Medicine
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 Group N:Naproxen sodium and Group NC :naproxen sodium codeine phosphate in people with Arthroscopic Meniscus Surgery, run by Baskent 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 1 inclusion and 7 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 30 Sep 2013. 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. 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?
Pain scores as measured by Visual Analogue Scale were significantly lower in Group Naproxen codeine (group NC) at all time points compared to Group Naproxen (group N) in 61 patients who underwent arthroscopic meniscus surgery. (time frame: postoperative 18 hours). 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 Sep 2013.