Postoperative Pain Treatment for Total Knee ArthroplastyNCT02164825
Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?
A study testing Ropivacaine perineural injection and morphine and ropivacaine in people with Postoperative Pain Treatment for Total Knee Arthroplasty, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
Trial summary
Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Treatment for Total Knee Arthroplasty
- What is being tested?
- Ropivacaine perineural injection and morphine and ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective total knee arthroplasty
Who cannot join
- Coagulopathy
- Neuropathy
- Morbid obesity
- local anesthetics allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial
Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty
- Being tested
- Ropivacaine perineural injection, morphine and ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine perineural injectionDrug
Ultrasound guided single-shot femoral nerve block
morphine and ropivacaineDrug
Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Single-shot nerve block | Experimental | Efficacy compared to epidural Receives: Drug: Ropivacaine perineural injection |
| Continuous epidural | Active comparator | Continuous epidural perfusion Receives: Drug: morphine and ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score on the numeric pain score
Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.
Measured: 48 hours
Secondary outcomes (3)
Side effects as a measure of safety and tolerability
Side effects of both interventions. Number of patients with side effects like nausea, vomiting, hypotension and pruritus.
Measured: 48 hours
Rescue analgesic consumption.
Opioid rescue needs in the first 48 hours after surgery.
Measured: 48 hours
Patients satisfaction.
Evaluation of patient´s satisfaction with pain control (asking the patient to classify the grade of satisfaction).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Treatment for Total Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Tâmega e Sousa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Marques da Cunha, Centro Hospitalar do Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164825
- Sponsor's protocol ID
- CHTSA001
- Status last verified
- Jun 2014
- First submitted
- 5 Jun 2014
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Single-shot Femoral Nerve Block and Epidural Techniques for Total Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02164825
- Acronym / sponsor ID
- CHTSA001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centro Hospitalar do Tâmega e SousaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 17 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.
Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-shot nerve block | Experimental | Drug: Ropivacaine perineural injectionEfficacy compared to epidural |
| Continuous epidural | Active comparator | Drug: morphine and ropivacaineContinuous epidural perfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective total knee arthroplasty
Key exclusion criteria (4 listed)
- Coagulopathy
- Neuropathy
- Morbid obesity
- local anesthetics allergy
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 |
|---|---|---|
| Ropivacaine perineural injectionUltrasound guided single-shot femoral nerve block | Drug | Single-shot nerve block |
| morphine and ropivacaineContinuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine. | Drug | Continuous epidural |
Primary outcome
Pain Score on the numeric pain score
Time frame: 48 hours
Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.
3 secondary outcomes
Side effects as a measure of safety and tolerability
Time frame: 48 hours
Rescue analgesic consumption.
Time frame: 48 hours
Patients satisfaction.
Time frame: 48 hours
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 5 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine perineural injection and morphine and ropivacaine in people with Postoperative Pain Treatment for Total Knee Arthroplasty, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
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 4 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 5 Feb 2015. 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 Portugal. 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.
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 Score on the numeric pain score (time frame: 48 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 5 Feb 2015.