Anterior Cruciate Ligament ReconstructionPhase 4NCT02604550

Anterior Cruciate Ligament Pain Study

A Phase 4 study testing Ropivacaine 0.5%, Percocet 7.5/325 and Naprosyn 500 mg in people with Anterior Cruciate Ligament Reconstruction, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction. Read more about this study

Who is it for?: Any age
Conditions the study is for: Anterior Cruciate Ligament Reconstruction
What is being tested?: Ropivacaine 0.5%, Percocet 7.5/325 and Naprosyn 500 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 1 siteUnited States
Study dates: Nov 2015to Apr 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
Patients willing and able to provide written informed consent
Parents willing and able to provide written informed consent for minors

Who cannot join

Patients who are pregnant or lactating
Patients with liver dysfunction or renal failure
Patients with a known allergy to ropivacaine
Patients with a local infection
Patients who take chronic pain medications
Patients with an opioid tolerance
Patients with known coagulopathy or bleeding risk.
Patients who are getting neuraxial anesthesia for surgery

Trial locations and contacts

1 site in 1 country.

United States1 site

Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, 30329

Other trials in United States

About this study

Official title: Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Read the detailed description

This trial is a prospective, randomized, surgeon-blinded, two-armed trial to investigate the safety and efficacy of femoral nerve blocks versus adductor canal blocks for participants undergoing outpatient anterior cruciate ligament (ACL) reconstruction surgery.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks. Ropivacaine, which is FDA-approved for use in both femoral nerve blocks as well as adductor canal blocks, will be utilized. The study will be comparing the efficacy between FDA approved treatments.

Conditions: Anterior Cruciate Ligament Reconstruction
Being tested: Ropivacaine 0.5%, Percocet 7.5/325, Naprosyn 500 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ropivacaine 0.5%Drug
Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
Percocet 7.5/325Drug
Percocet 7.5/325 will taken as needed up to every four hours.
Naprosyn 500 mgDrug
Naprosyn 500 mg will be taken twice daily.

Study groups in NCT02604550
Study group	Role	What they receive
Femoral Nerve Block	Active comparator	Subjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. Receives: Drug: Ropivacaine 0.5%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg
Adductor Canal Block	Active comparator	Subjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery. Receives: Drug: Ropivacaine 0.5%; Drug: Percocet 7.5/325; Drug: Naprosyn 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Score
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.
Measured: Post-surgery (day of surgery to 6 days post-surgery)

Secondary outcomes (9)

Number of Percocet Tablets Consumed
Participants recorded the total number of Percocet 7.5/325 (acetaminophen and oxycodone) tablets they took every day, in order to assess post-surgical use of opioids between the study arms,
Measured: Post surgery, Day 0 to Day 6
Total Hours of Sleep
The total hours of sleep first postoperative night, between 0 to 12 hours.
Measured: First Postoperative Night (up to 12 hours)
Patient-Reported Nausea
Total occurrences of patient-reported nausea post-surgery.
Measured: Post-Surgery (up to 6 days)
Patient-Reported Vomiting
Total occurrences of patient-reported vomiting post-surgery.
Measured: Post-Surgery (up to 6 days)
Patient-Reported Constipation
Total occurrences of patient-reported constipation post-surgery.
Measured: Post-Surgery (up to 6 days)
Patient-Reported Sedation
Total occurrences of patient-reported feelings of sedation post-surgery.
Measured: Post-Surgery (up to 6 days)
Patient-Reported Itching
Total occurrences of patient-reported itching post-surgery.
Measured: Post-Surgery (up to 6 days)
Time to Straight Less Raise
The amount of time (in hours) it takes for participants to have the ability to perform a straight leg raise post-surgery.
Measured: Post-Surgery (up to 6 days)
Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"
Patient satisfaction will be reported on a scale of excellent, good, satisfactory, or poor, two weeks following surgery.
Measured: 2 Weeks Post-Surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Apr 2016

First posted13 Nov 2015 (estimated)
Study startNov 2015
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
More trials run by Emory UniversityThe 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02604550
Sponsor's protocol ID: IRB00083740
Status last verified: Apr 2017
First submitted: 11 Nov 2015
Last updated: 31 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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All Anterior Cruciate Ligament Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison Between Femoral Nerve Block and Adductor Canal Block for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02604550
Acronym / sponsor ID: IRB00083740
Conditions: Anterior Cruciate Ligament Reconstruction
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Emory UniversityUniversity, hospital or other
Study start: Nov 2015
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 13 Nov 2015 (estimated)
Results: Posted 31 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to compare the pain control benefit of two different types of nerve blocks in patients undergoing anterior cruciate ligament (ACL) reconstruction.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Femoral Nerve Block	Active comparator	Drug: Ropivacaine 0.5%, Drug: Percocet 7.5/325, Drug: Naprosyn 500 mgSubjects undergoing anterior cruciate ligament (ACL) surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the femoral nerve. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.
Adductor Canal Block	Active comparator	Drug: Ropivacaine 0.5%, Drug: Percocet 7.5/325, Drug: Naprosyn 500 mgSubjects undergoing anterior cruciate ligament surgery will be randomized to receive 20 mL of ropivacaine 0.5% in the adductor canal. Subjects will also receive standard of care Percocet 7.5/325 and naprosyn following surgery.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients undergoing scheduled anterior cruciate ligament (ACL) surgery at the Emory Orthopaedic and Spine Center
Patients willing and able to provide written informed consent
Parents willing and able to provide written informed consent for minors

Key exclusion criteria (8 listed)

Patients who are pregnant or lactating
Patients with liver dysfunction or renal failure
Patients with a known allergy to ropivacaine
Patients with a local infection
Patients who take chronic pain medications

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 0.5%Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.	Drug	Adductor Canal Block, Femoral Nerve Block
Percocet 7.5/325Percocet 7.5/325 will taken as needed up to every four hours.	Drug	Adductor Canal Block, Femoral Nerve Block
Naprosyn 500 mgNaprosyn 500 mg will be taken twice daily.	Drug	Adductor Canal Block, Femoral Nerve Block

Primary outcome

Pain Score
Time frame: Post-surgery (day of surgery to 6 days post-surgery)
Pain scores range from 0 (no pain at all) to 10 (worst imaginable pain). Pain level was reported at the time of discharge from the surgery recovery room, the evening of the day of surgery, and then three times per day for six days post-surgery. During the six days after surgery, the morning assessment asked about typical knee pain levels overnight, the afternoon assessment asked about knee pain levels since the morning entry, and the evening assessment asked about knee pain levels since the afternoon entry.

9 secondary outcomes

Number of Percocet Tablets Consumed
Time frame: Post surgery, Day 0 to Day 6
Total Hours of Sleep
Time frame: First Postoperative Night (up to 12 hours)
Patient-Reported Nausea
Time frame: Post-Surgery (up to 6 days)
Patient-Reported Vomiting
Time frame: Post-Surgery (up to 6 days)
Patient-Reported Constipation
Time frame: Post-Surgery (up to 6 days)
Patient-Reported Sedation
Time frame: Post-Surgery (up to 6 days)
Patient-Reported Itching
Time frame: Post-Surgery (up to 6 days)
Time to Straight Less Raise
Time frame: Post-Surgery (up to 6 days)
Percent of Patients Rating Their Satisfaction as "Excellent" or "Good"
Time frame: 2 Weeks Post-Surgery

Results and safety

Results posted to the registry on 31 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Femoral Nerve Block	56	31
Adductor Canal Block	59	33

Primary outcome: Pain Score

Time frame: Post-surgery (day of surgery to 6 days post-surgery). Mean (Standard Deviation). Unit: units on a scale

Measure	Femoral Nerve Block n = 31	Adductor Canal Block n = 33
Recovery room discharge	4.1 (1.8)	4.0 (2.8)
Day of surgery, evening	3.9 (2.2)	5.1 (2.9)
Post-surgery Day 1 - Morning	5.7 (2.6)	5.7 (2.4)
Post-surgery Day 1 - Afternoon	5.1 (2.3)	5.0 (1.8)
Post-surgery Day 1 - Evening	5.5 (2.3)	6.0 (2.1)
Post-surgery Day 2 - Morning	5.4 (2.3)	5.3 (2.3)
Post-surgery Day 2 - Afternoon	4.5 (1.9)	4.6 (1.8)
Post-surgery Day 2 - Evening	4.3 (2.0)	4.5 (2.1)

Population analysed: This analysis includes participants who completed the study and used a smartphone application to record pain level for 6 days post-surgery.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data regarding adverse events were collected from the time a participant gave informed consent to take part in the study until the end of the study follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Femoral Nerve Block	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Adductor Canal Block	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Limitations and caveats (from the sponsor): Data collection with a paper journal was low, resulting in the study switching to a smartphone application for participant record keeping. The data analyses include participants who enrolled after the smartphone application became available.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Anterior Cruciate Ligament Reconstruction

Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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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.

John Xerogeanes, MD principal investigator

Emory University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ropivacaine 0.5%, Percocet 7.5/325 and Naprosyn 500 mg in people with Anterior Cruciate Ligament Reconstruction, run by Emory University 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 8 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 31 May 2017. 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.

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?

Yes. Results are posted in the registry (first posted 31 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain Score (time frame: Post-surgery (day of surgery to 6 days post-surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02604550.

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 31 May 2017.