Pain, PostoperativePhase 4NCT02344264
Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
A Phase 4 study testing Ropivacaine and Saline in people with Pain, Postoperative and Ropivacaine, run by Daniel Hägi-Pedersen at 1 site in Denmark.
Trial summary
The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Pain, Postoperative, Ropivacaine, Therapeutic Use
- What is being tested?
- Ropivacaine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Sep 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication.
- informed consent
- ASA 1-3
- BMI 18-40
Who cannot join
- Unable to communicate in danish
- Allergic reactions toward drugs used
- Abuse of alcohol/drugs
- Unable to cooperate
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.
Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
- Being tested
- Ropivacaine, Saline
- Keywords
- US guided nerve block, Total hip Arthroplasty, NCFL, nervus cutaneous femoralis lateralis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
SalineDrug
Also called NaCl, Placebo
Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml.
| Study group | Role | What they receive |
|---|---|---|
| RP | Other | first blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml Receives: Drug: Ropivacaine; Drug: Saline |
| PR | Other | first blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml Receives: Drug: Ropivacaine; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
Measured: 45 min
Secondary outcomes (2)
Difference in mean VAS between the groups during active hip flexion
Measured: 15, 30, 45, 60, 75, 90 min
Difference in mean VAS between the groups at rest
Measured: 15, 30, 45, 60, 75, 90 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Hägi-Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Hägi-Pedersen, Naestved Hospital
- Investigators
- Daniel Hägi-Pedersen, Ph.D., Study chair, Naestved Hospital, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344264
- Sponsor's protocol ID
- PROTOKOL - 001-2014 - KHTY
- Other IDs
- 2014-003730-10, 2014
- Status last verified
- Sep 2015
- First submitted
- 16 Jan 2015
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02344264
- Acronym / sponsor ID
- PROTOKOL - 001-2014 - KHTY
- Keywords
- US guided nerve block, Total hip Arthroplasty, NCFL, nervus cutaneous femoralis lateralis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Daniel Hägi-PedersenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jan 2015 (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.
The patients will be included the 1. or 2. day after surgery. All THA patients will be screened. Those reporting VAS > 40 during active 30 degrees hip flexion will be asked to participate.
Included patients will receive 2xNCFL (singleshot) first placebo (8 ml saline) and then ropivacaine (8 ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
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 |
|---|---|---|
| RP | Other | Drug: Ropivacaine, Drug: Salinefirst blockade: ropivacaine 7,5mg/ml 8 ml second blockade: placebo: saline 8 ml |
| PR | Other | Drug: Ropivacaine, Drug: Salinefirst blockade: placebo: saline 8 ml second blockade: ropivacaine 7,5mg/ml 8 ml |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication.
- informed consent
- ASA 1-3
- BMI 18-40
Key exclusion criteria (5 listed)
- Unable to communicate in danish
- Allergic reactions toward drugs used
- Abuse of alcohol/drugs
- Unable to cooperate
- Pregnant women
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 |
|---|---|---|
| RopivacaineAlso: NaropinArm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml. | Drug | PR, RP |
| SalineAlso: NaCl, PlaceboArm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml). Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml. | Drug | PR, RP |
Primary outcome
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion
Time frame: 45 min
2 secondary outcomes
Difference in mean VAS between the groups during active hip flexion
Time frame: 15, 30, 45, 60, 75, 90 min
Difference in mean VAS between the groups at rest
Time frame: 15, 30, 45, 60, 75, 90 min
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 25 Sep 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.
Daniel Hägi-Pedersen, Ph.D. study chair
Naestved Hospital, Department of Anaesthesiology
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 Ropivacaine and Saline in people with Pain, Postoperative and Ropivacaine, run by Daniel Hägi-Pedersen at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 25 Sep 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 Denmark. 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?
Difference in VAS between NCFL and placebo during active 30 degrees hip flexion (time frame: 45 min). 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 25 Sep 2015.