Postoperative PainNCT01068275
Lumbar Plexus Catheter Versus Femoral Nerve Catheter for Postoperative Pain After Anterior Cruciate Ligament (ACL) Repair
A study testing lumbar plexus catheter, femoral nerve catheter and single-shot femoral block in people with Postoperative Pain, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- lumbar plexus catheter, femoral nerve catheter and single-shot femoral block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 2012
- 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 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA physical status 1-2
- Age 11-21
- Undergoing anterior cruciate ligament repair
Who cannot join
- Patient refusal
- Coagulopathy
- Systemic infection or infection at needle insertion site
- Allergy to ropivacaine or opioids
- Taking chronic opioids
- Unavailable by phone
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Michelle Sadler-Greever, RN, 206-987-1937
Felicia M. Birch, MD, 206-987-3996
About this study
Official title: Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction
Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.
- Conditions
- Postoperative Pain
- Being tested
- lumbar plexus catheter, femoral nerve catheter, single-shot femoral block
- Keywords
- anterior cruciate ligament, pain, postoperative, peripheral nerve catheter, nerve block, Children undergoing anterior cruciate ligament repair
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar plexus catheterProcedure or surgery
Also called psoas compartment catheter
lumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
femoral nerve catheterProcedure or surgery
femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
single-shot femoral blockProcedure or surgery
single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)
| Study group | Role | What they receive |
|---|---|---|
| Lumbar plexus catheter | Active comparator | Not described Receives: Procedure: lumbar plexus catheter |
| femoral nerve catheter | Active comparator | Not described Receives: Procedure: femoral nerve catheter |
| single-shot femoral block | Active comparator | Not described Receives: Procedure: single-shot femoral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Measured: 72 hours
Secondary outcomes (3)
Quality of recovery
Measured: 72 hours
Opioid consumption
Measured: 72 hours
Opioid side effects
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
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.
- More trials run by Seattle Children's HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Felicia M Birch, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068275
- Sponsor's protocol ID
- SCHAnes1
- Status last verified
- Aug 2010
- First submitted
- 11 Feb 2010
- Last updated
- 26 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Plexus Catheter Versus Femoral Nerve Catheter Versus Single-shot Femoral Block for Postoperative Pain Control After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01068275
- Acronym / sponsor ID
- SCHAnes1
- Conditions
- Postoperative Pain
- Keywords
- anterior cruciate ligament, pain, postoperative, peripheral nerve catheter, nerve block, Children undergoing anterior cruciate ligament repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 12 Feb 2010 (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.
Randomized trial comparing lumbar plexus catheter versus femoral nerve catheter (single-shot femoral block as control group) for postoperative pain control after anterior cruciate ligament repair in children (age 11-21). Primary outcome is pain scores for the first 72 hours. Secondary outcomes include opioid consumption, incidence of opioid side effects and quality of recovery (previously validated scale). Our hypothesis is that lumbar plexus catheter will provide superior pain control and overall quality of recovery compared to femoral nerve catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lumbar plexus catheter | Active comparator | Procedure: lumbar plexus catheter |
| femoral nerve catheter | Active comparator | Procedure: femoral nerve catheter |
| single-shot femoral block | Active comparator | Procedure: single-shot femoral block |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA physical status 1-2
- Age 11-21
- Undergoing anterior cruciate ligament repair
Key exclusion criteria (6 listed)
- Patient refusal
- Coagulopathy
- Systemic infection or infection at needle insertion site
- Allergy to ropivacaine or opioids
- Taking chronic opioids
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 |
|---|---|---|
| lumbar plexus catheterAlso: psoas compartment catheterlumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr) | Procedure or surgery | Lumbar plexus catheter |
| femoral nerve catheterfemoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr) | Procedure or surgery | femoral nerve catheter |
| single-shot femoral blocksingle-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml) | Procedure or surgery | single-shot femoral block |
Primary outcome
Postoperative pain scores
Time frame: 72 hours
3 secondary outcomes
Quality of recovery
Time frame: 72 hours
Opioid consumption
Time frame: 72 hours
Opioid side effects
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2010.
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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.
Felicia M Birch, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar plexus catheter, femoral nerve catheter and single-shot femoral block in people with Postoperative Pain, run by Seattle Children's Hospital at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2010. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Sadler-Greever, RN (206-987-1937, michelle.sadler-greever@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores (time frame: 72 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 26 Aug 2010.