Postoperative PainNCT00790179
Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
A study testing continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA in people with Postoperative Pain, run by Northwell Health.
Trial summary
Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Mar 2007
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old
- primary diagnosis of osteoarthritis
Who cannot join
- allergy to local anesthetics
- peripheral neuropathy
- opioid dependency
- dementia
- coagulopathy
About this study
Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty.
Read the detailed description
above may be applied
- Conditions
- Postoperative Pain
- Being tested
- continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA
- Keywords
- Continuous lumbar plexus,Femoral,hydromorphone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCAProcedure or surgery
0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.
Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.
| Study group | Role | What they receive |
|---|---|---|
| PCA;active comparator | Active comparator | Patients with intravenous PCA hydromorphone alone Receives: Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA |
| CFB | Active comparator | Patients with a continuous femoral block (CFB) + PCA hydromorphone Receives: Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA |
| CLPB | Active comparator | Patients with a continuous lumbar plexus block + PCA hydromorphone Receives: Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain scores
Measured: at 24 and 48 hours
Secondary outcomes (1)
hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects
Measured: at 24 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJan 2003
- Primary completionJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Investigators
- Joseph Marino, M.D., Principal investigator, Huntington Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790179
- Sponsor's protocol ID
- 1989md
- Status last verified
- Nov 2008
- First submitted
- 12 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00790179
- Acronym / sponsor ID
- 1989md
- Conditions
- Postoperative Pain
- Keywords
- Continuous lumbar plexus,Femoral,hydromorphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 13 Nov 2008 (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.
Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty.
Detailed description
above may be applied
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA;active comparator | Active comparator | Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCAPatients with intravenous PCA hydromorphone alone |
| CFB | Active comparator | Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCAPatients with a continuous femoral block (CFB) + PCA hydromorphone |
| CLPB | Active comparator | Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCAPatients with a continuous lumbar plexus block + PCA hydromorphone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years old
- primary diagnosis of osteoarthritis
Key exclusion criteria (5 listed)
- allergy to local anesthetics
- peripheral neuropathy
- opioid dependency
- dementia
- coagulopathy
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 |
|---|---|---|
| continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB. Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA. | Procedure or surgery | CFB, CLPB, PCA;active comparator |
Primary outcome
VAS pain scores
Time frame: at 24 and 48 hours
1 secondary outcome
hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects
Time frame: at 24 and 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 13 Nov 2008.
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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.
Joseph Marino, M.D. principal investigator
Huntington Hospital
Questions about this trial
What is this clinical trial studying?
A study testing continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA in people with Postoperative Pain, run by Northwell Health.
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 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 13 Nov 2008. 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?
VAS pain scores (time frame: at 24 and 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 13 Nov 2008.