Pain, PostoperativePhase 4NCT02289937
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
A Phase 4 study testing Ropivacaine and An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively in people with Pain, Postoperative and Anesthesia, Conduction, run by Daniel Hägi-Pedersen.
Trial summary
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip
- What is being tested?
- Ropivacaine and An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total hip replacement
Who cannot join
- general anaesthesia
- Allergy to local anesthetics of the amide type
- Revision surgery
- Bilateral surgery
- Chronic pain patient
- Women in the fertile age
About this study
Official title: Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.
- Being tested
- Ropivacaine, Placebo, An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
- Keywords
- Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral 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
PlaceboDrug
Also called Saline, NaCl
An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperativelyDevice
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | 8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided. Receives: Drug: Ropivacaine; Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively |
| Placebo | Placebo comparator | 8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided Receives: Drug: Placebo; Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-score 4 hours postoperative during movement
VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Measured: 4 hours postoperative
Secondary outcomes (7)
VAS-score 0-24 hours postoperative during movement
VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Measured: 0-24 hours postoperatively
VAS-score 0-24 hours postoperative at rest
VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Measured: 0-24 hours postoperatively
Oxynorm consumption
Oxynorm consumption 24 hours postoperative
Measured: 0-24 hours postoperative
time to first oxynorm requirement
Measured: 0-24 hours postoperatively
Mobilization
time to first mobilization
Measured: 0-24 hours postoperatively
Mobilization
Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
Measured: 0-24 hours postoperatively
Length of stay
Measured: 0-7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- 100 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, M.D., Ph.D., Study chair, Naestved Hospital, Department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289937
- Sponsor's protocol ID
- 001-2013
- Other IDs
- 2013-004501-12
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT02289937
- Acronym / sponsor ID
- 001-2013
- Keywords
- Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Daniel Hägi-PedersenUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Nov 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.
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.
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 |
|---|---|---|
| Ropivacaine | Experimental | Drug: Ropivacaine, Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided. |
| Placebo | Placebo comparator | Drug: Placebo, Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total hip replacement
Key exclusion criteria (6 listed)
- general anaesthesia
- Allergy to local anesthetics of the amide type
- Revision surgery
- Bilateral surgery
- Chronic pain patient
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: Naropin | Drug | Ropivacaine |
| PlaceboAlso: Saline, NaCl | Drug | Placebo |
| An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively | Device | Placebo, Ropivacaine |
Primary outcome
VAS-score 4 hours postoperative during movement
Time frame: 4 hours postoperative
VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
7 secondary outcomes
VAS-score 0-24 hours postoperative during movement
Time frame: 0-24 hours postoperatively
VAS-score 0-24 hours postoperative at rest
Time frame: 0-24 hours postoperatively
Oxynorm consumption
Time frame: 0-24 hours postoperative
time to first oxynorm requirement
Time frame: 0-24 hours postoperatively
Mobilization
Time frame: 0-24 hours postoperatively
Mobilization
Time frame: 0-24 hours postoperatively
Length of stay
Time frame: 0-7 days postoperative
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 13 Nov 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.
Daniel Hägi-Pedersen, M.D., Ph.D. study chair
Naestved Hospital, Department of Anaesthesiology
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively in people with Pain, Postoperative and Anesthesia, Conduction, run by Daniel Hägi-Pedersen.
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 6 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 13 Nov 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?
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?
VAS-score 4 hours postoperative during movement (time frame: 4 hours postoperative). 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 13 Nov 2014.