Acute Postoperative PainEarly Phase 1NCT02115945
Femoral and Epidural Block After Total Knee Arthroplasty
A Early Phase 1 study testing DN4 test, The SF 12 test and HAD scale in people with Acute Postoperative Pain and Chronic Postoperative Pain, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Postoperative Pain, Chronic Postoperative Pain
- What is being tested?
- DN4 test, The SF 12 test and HAD scale
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Mar 2014
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of total knee arthroplasty
Who cannot join
- Patients with pain syndromes
- Patients using routinely medications for pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100
About this study
Official title: COMPARISON OF CONTINUOUS FEMORAL NERVE BLOCK AND PATIENT CONTROLLED EPIDURAL ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY
Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Read the detailed description
Background and aim Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Methods The study was of randomized, prospective, and double-blind design and was conducted with 80 patients who had undergone total knee prosthetic replacement surgery with the insertion of a femoral nerve block or epidural block catheter to initiate postoperative analgesia. One-sided spinal anesthesia was performed in all the patients. Postoperative pain control was achieved with the administration via catheter using bupivacaine for patient-controlled analgesia. Acute postoperative pain was evaluated in the first 24 hours and chronic postoperative pain in the 1st and 3rd months following surgery. The anxiety/depression scale was used to assess anxiety and depression, the SF 12 test was used to evaluate quality of life, and the DN4 test was employed at patient visits at the 1st and 3rd months.
- Being tested
- DN4 test, The SF 12 test, HAD scale, Visual analogue score, femoral block
- Keywords
- chronic postoperative pain, total knee arthroplasty, femoral block, We aimed to compare the effects of epidural and femoral block on acute and chronic 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.
DN4 testOther
The DN4 test was used to evaluate neuropathic pain.
The SF 12 testOther
Also called SHORT FORM 12
The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
HAD scaleOther
Also called The anxiety/depression scale
The anxiety/depression scale (HAD) was used to assess anxiety and depression.
Visual analogue scoreOther
Also called VAS score
Visual analogue score vas used to evaluate pain.
femoral blockProcedure or surgery
epidural blockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| epidural block | Experimental | Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain. Receives: Other: DN4 test; Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score; Procedure: epidural block |
| femoral block | Active comparator | Visual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain. Receives: Other: DN4 test; Other: The SF 12 test; Other: HAD scale; Other: Visual analogue score; Procedure: femoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent surgical pain after total knee arthroplasty assessed by VAS scale
Measured: 3 months
Secondary outcomes (1)
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Acute Postoperative PainStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SINEM SARI, Aydin Adnan Menderes University
- Investigators
- Sinem Sari, Assistant Prof, Study chair, Adnan Menderes University Medical Faculty Anesthesiology and Reanimation DepartmentFatma Şengül, MD, Principal investigator, Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; TurkeyFabrizioGalimberti Galimberti, Medical Student, Principal investigator, Cleveland ClinicLernerCollege of Medicine, Cleveland, OhioBilge Karslı, Prof, Principal investigator, Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; TurkeyAlparslan Turan, Associate Prof, Principal investigator, The Cleveland ClinicMurat Bakıs, Assistant Prof, Principal investigator, Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department, Aydin; Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115945
- Sponsor's protocol ID
- SARI-01
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan EY, Fransen M, Sathappan S, Chua NH, Chan YH, Chua N. Comparing the analgesia effects of single-injection and continuous femoral nerve blocks with patient controlled analgesia after total knee arthroplasty. J Arthroplasty. 2013 Apr;28(4):608-13. doi: 10.1016/j.arth.2012.06.039. Epub 2012 Nov 8.
PubMed 23142441
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CONTINUOUS FEMORAL NERVE BLOCK AND PATIENT CONTROLLED EPIDURAL ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY
- ClinicalTrials.gov ID
- NCT02115945
- Acronym / sponsor ID
- SARI-01
- Keywords
- chronic postoperative pain, total knee arthroplasty, femoral block, We aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Apr 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.
Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Detailed description
Background and aim Total knee prosthetic replacement causes severe postoperative pain. Various analgesic techniques have been used in pain control. Comparison of epidural and femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Methods The study was of randomized, prospective, and double-blind design and was conducted with 80 patients who had undergone total knee prosthetic replacement surgery with the insertion of a femoral nerve block or epidural block catheter to initiate postoperative analgesia. One-sided spinal anesthesia was performed in all the patients. Postoperative pain control was achieved with the administration via catheter using bupivacaine for patient-controlled analgesia. Acute postoperative pain was evaluated in the first 24 hours and chronic postoperative pain in the 1st and 3rd months following surgery. The anxiety/depression scale was used to assess anxiety and depression, the SF 12 test was used to evaluate quality of life, and the DN4 test was employed at patient visits at the 1st and 3rd months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural block | Experimental | Other: DN4 test, Other: The SF 12 test, Other: HAD scale, Other: Visual analogue score, Procedure: epidural blockVisual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain. |
| femoral block | Active comparator | Other: DN4 test, Other: The SF 12 test, Other: HAD scale, Other: Visual analogue score, Procedure: femoral blockVisual anlogue score vas used to evaluate pain. The anxiety/depression scale (HAD) was used to assess anxiety and depression. The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. The DN4 test was used to evaluate neuropathic pain. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of total knee arthroplasty
Key exclusion criteria (2 listed)
- Patients with pain syndromes
- Patients using routinely medications for pain
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 |
|---|---|---|
| DN4 testThe DN4 test was used to evaluate neuropathic pain. | Other | epidural block, femoral block |
| The SF 12 testAlso: SHORT FORM 12The SF 12 test (SHORT FORM 12) was used to evaluate quality of life. | Other | epidural block, femoral block |
| HAD scaleAlso: The anxiety/depression scaleThe anxiety/depression scale (HAD) was used to assess anxiety and depression. | Other | epidural block, femoral block |
| Visual analogue scoreAlso: VAS scoreVisual analogue score vas used to evaluate pain. | Other | epidural block, femoral block |
| femoral block | Procedure or surgery | femoral block |
| epidural block | Procedure or surgery | epidural block |
Primary outcome
Persistent surgical pain after total knee arthroplasty assessed by VAS scale
Time frame: 3 months
1 secondary outcome
The anxiety and depression was evaluated with Hospital anxiety and depression scale.
Time frame: 3 months
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 16 Apr 2014.
- Results publication: PubMed 23142441Chan EY, Fransen M, Sathappan S, Chua NH, Chan YH, Chua N. Comparing the analgesia effects of single-injection and continuous femoral nerve blocks with patient controlled analgesia after total knee arthroplasty. J Arthroplasty. 2013 Apr;28(4):608-13. doi: 10.1016/j.arth.2012.06.039. Epub 2012 Nov 8.
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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.
Sinem Sari, Assistant Prof study chair
Adnan Menderes University Medical Faculty Anesthesiology and Reanimation Department
Fatma Şengül, MD principal investigator
Antalya Education and Research Hospital, Anesthesiology and Reanimation Department, Antalya; Turkey
FabrizioGalimberti Galimberti, Medical Student principal investigator
Cleveland ClinicLernerCollege of Medicine, Cleveland, Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing DN4 test, The SF 12 test and HAD scale in people with Acute Postoperative Pain and Chronic Postoperative Pain, run by Aydin Adnan Menderes 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 2 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 16 Apr 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Persistent surgical pain after total knee arthroplasty assessed by VAS scale (time frame: 3 months). 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 NCT02115945, 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 16 Apr 2014.