Anterior Cruciate LigamentNCT01919658
Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair
A study testing nerve block in people with Anterior Cruciate Ligament, run by Robert A. Gallo at 1 site in United States.
Trial summary
The primary objective of the study is to compare motor strength in knee extension between two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one receiving a distal thigh block of the saphenous nerve. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 10 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65
- Upcoming ACL reconstruction using patellar tendon autograft scheduled at Hershey Medical Center or the Hershey Outpatient Surgical Center (HOSC)
Who cannot join
- Documented neuropathy
- Skeletally immature
- Previous knee surgery
- Inability to provide informed consent
- ACL reconstruction with other tendon repairs
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Effects of Femoral Versus Saphenous Nerve Blocks on Knee Extensor Strength, Pain, and Patient-Perceived Physical Function Following ACL Reconstruction
The primary objective of the study is to compare motor strength in knee extension between two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare the pain relief and functional outcomes in these two groups.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- nerve block
- Keywords
- nerve blocks in Anterior cruciate ligament surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve blockProcedure or surgery
A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).
| Study group | Role | What they receive |
|---|---|---|
| proximal nerve block | Active comparator | The anesthesiologist will administer a proximal nerve block if specified in the randomization envelope. Receives: Procedure: nerve block |
| distal nerve block | Active comparator | The anesthesiologist will administer a distal nerve block if specified in the randomization envelope. Receives: Procedure: nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength of knee extensors
Extensor testing will be conducted in both legs using a hand held dynamometer.
Measured: change from baseline preoperatively at 12 months
Secondary outcomes (1)
pain level and functional outcomes
Medical record will be reviewed for type and amount of in hospital post operative medication and levels, then assessed by PROMIS survey at follow up appointments.
Measured: change from in hospital post-operative period at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJul 2013
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
Why it stopped: Difficulty enrolling, aim already examined in literature.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert A. Gallo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert A. Gallo, Milton S. Hershey Medical Center
- Investigators
- Robert Gallo, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919658
- Sponsor's protocol ID
- IRB 42734
- Status last verified
- Jun 2019
- First submitted
- 6 Aug 2013
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Femoral Versus Saphenous Nerve Blocks on Knee Extensor Strength, Pain, and Patient-Perceived Physical Function Following ACL Reconstruction
- ClinicalTrials.gov ID
- NCT01919658
- Acronym / sponsor ID
- IRB 42734
- Conditions
- Anterior Cruciate Ligament
- Keywords
- nerve blocks in Anterior cruciate ligament surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty enrolling, aim already examined in literature.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Robert A. GalloUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 9 Aug 2013 (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 primary objective of the study is to compare motor strength in knee extension between two groups of patients. One group receiving a proximal thigh block of the femoral nerve, and one receiving a distal thigh block of the saphenous nerve. The secondary objective is to compare the pain relief and functional outcomes in these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proximal nerve block | Active comparator | Procedure: nerve blockThe anesthesiologist will administer a proximal nerve block if specified in the randomization envelope. |
| distal nerve block | Active comparator | Procedure: nerve blockThe anesthesiologist will administer a distal nerve block if specified in the randomization envelope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65
- Upcoming ACL reconstruction using patellar tendon autograft scheduled at Hershey Medical Center or the Hershey Outpatient Surgical Center (HOSC)
Key exclusion criteria (5 listed)
- Documented neuropathy
- Skeletally immature
- Previous knee surgery
- Inability to provide informed consent
- ACL reconstruction with other tendon repairs
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 |
|---|---|---|
| nerve blockA nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle). | Procedure or surgery | distal nerve block, proximal nerve block |
Primary outcome
strength of knee extensors
Time frame: change from baseline preoperatively at 12 months
Extensor testing will be conducted in both legs using a hand held dynamometer.
1 secondary outcome
pain level and functional outcomes
Time frame: change from in hospital post-operative period at 12 months
Results and safety
The study was stopped early (reason given: Difficulty enrolling, aim already examined in literature.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
Related trials for Anterior Cruciate Ligament
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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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.
Robert Gallo, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block in people with Anterior Cruciate Ligament, run by Robert A. Gallo 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 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: stopped early, as of the sponsor's last update on 21 Jun 2019. 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?
The study was stopped early (reason given: Difficulty enrolling, aim already examined in literature.). Results are not available in the source record.
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?
strength of knee extensors (time frame: change from baseline preoperatively at 12 months). 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 21 Jun 2019.