PainNCT00150865
Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery
A study testing ropivacaine in people with Pain and Postoperative, run by University Hospital, Angers.
Trial summary
Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ropivacaine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to Mar 2002
- 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
- adults
- ASA 1-3
Who cannot join
- cognitive impairement
- ASA IV
About this study
Official title: Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery
Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.
Expectation : sizeable reduction of pain with block, of duration.
Read the detailed description
Compare lumbar plexus block (randomized)
- ropivacaine 0.475%, 0.4 ml/kg
- saline 0.4 ml/kg . Each group includes 30 patients.
Block performed preoperatively.
Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.
Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.
Adverse effects (nausea, vomiting, etc) recorded
Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.
- Conditions
- Pain, Postoperative
- Being tested
- ropivacaine
- Keywords
- ropivacaine, posterior lumbar plexus block, hip arthroplasy, analgesia, postoperative
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease of postoperative pain
Secondary outcomes (2)
decrease in morphine consumption
duraration of analgesic effect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- laurent beydon, MD, Study director, University Hospital, Angersibrahim okais, MD, Principal investigator, Clinique St Leonard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150865
- Sponsor's protocol ID
- CP 02-01
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 1 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery
- ClinicalTrials.gov ID
- NCT00150865
- Acronym / sponsor ID
- CP 02-01
- Conditions
- Pain, Postoperative
- Keywords
- ropivacaine, posterior lumbar plexus block, hip arthroplasy, analgesia, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2001
- Study completion
- Mar 2002
- First posted
- 8 Sep 2005 (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.
Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.
Expectation : sizeable reduction of pain with block, of duration.
Detailed description
Compare lumbar plexus block (randomized)
- ropivacaine 0.475%, 0.4 ml/kg
- saline 0.4 ml/kg . Each group includes 30 patients.
Block performed preoperatively.
Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.
Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.
Adverse effects (nausea, vomiting, etc) recorded
Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults
- ASA 1-3
Key exclusion criteria (2 listed)
- cognitive impairement
- ASA IV
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 | Drug | – |
Primary outcome
decrease of postoperative pain
2 secondary outcomes
decrease in morphine consumption
duraration of analgesic effect
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 1 Nov 2017.
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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.
laurent beydon, MD study director
University Hospital, Angers
ibrahim okais, MD principal investigator
Clinique St Leonard
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine in people with Pain and Postoperative, run by University Hospital, Angers.
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 2 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 1 Nov 2017. 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. 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?
decrease of postoperative pain. 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 1 Nov 2017.