Internal Derangement of KneePhase 4NCT01279447

Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control

A Phase 4 study testing 0.25% Bupivacaine and Normal Saline in people with Internal Derangement of Knee, run by Northwestern 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 purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Internal Derangement of Knee
What is being tested?: 0.25% Bupivacaine and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Jan 2011to Aug 2013
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

planned knee arthroscopy with soft tissue intervention
age 18+
English speaking

Who cannot join

contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
knee arthroscopy with planned bony intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

Olson Surgical Pavilion
Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy

Read the detailed description

Conditions: Internal Derangement of Knee
Being tested: 0.25% Bupivacaine, Normal Saline
Keywords: infrapatellar nerve, saphenous nerve, knee arthroscopy, nerve block

What participants receive

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

0.25% BupivacaineDrug
Also called Nerve block
10cc, single dose, US guided injection
Normal SalineDrug
Also called Placebo
10cc, single dose, US guided injection

Study groups in NCT01279447
Study group	Role	What they receive
Placebo	Sham comparator	A sham infrapatellar block performed under US guidance with normal saline Receives: Drug: Normal Saline
Infrapatellar nerve block	Experimental	An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine Receives: Drug: 0.25% Bupivacaine

What is being measured

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

Post op Pain Score
immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.
Measured: 0 hours

Timeline

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

Jan 2011Aug 2013

First posted19 Jan 2011 (estimated)
Study startJan 2011
Primary completionAug 2013
Study completionAug 2013

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Internal Derangement of KneeStudies of the same condition, open and under way.
More trials run by Northwestern 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01279447
Sponsor's protocol ID: STU00026632
Status last verified: Jan 2014
First submitted: 17 Jan 2011
Last updated: 12 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
PubMed 18574578
Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.
PubMed 17005509
Arthornthurasook A, Gaew-Im K. Study of the infrapatellar nerve. Am J Sports Med. 1988 Jan-Feb;16(1):57-9. doi: 10.1177/036354658801600110.
PubMed 3344881

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy
ClinicalTrials.gov ID: NCT01279447
Acronym / sponsor ID: STU00026632
Conditions: Internal Derangement of Knee
Keywords: infrapatellar nerve, saphenous nerve, knee arthroscopy, nerve block
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: Jan 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 19 Jan 2011 (estimated)
Results: Posted 12 May 2014

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Placebo	Sham comparator	Drug: Normal SalineA sham infrapatellar block performed under US guidance with normal saline
Infrapatellar nerve block	Experimental	Drug: 0.25% BupivacaineAn infrapatellar nerve block performed under US guidance with 0.25% bupivacaine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

planned knee arthroscopy with soft tissue intervention
age 18+
English speaking

Key exclusion criteria (2 listed)

contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
knee arthroscopy with planned bony intervention

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
0.25% BupivacaineAlso: Nerve block10cc, single dose, US guided injection	Drug	Infrapatellar nerve block
Normal SalineAlso: Placebo10cc, single dose, US guided injection	Drug	Placebo

Primary outcome

Post op Pain Score
Time frame: 0 hours
immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.

Results and safety

Results posted to the registry on 12 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	34	31
Infrapatellar Nerve Block	34	33

Primary outcome: Post op Pain Score

Time frame: 0 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 34	Infrapatellar Nerve Block n = 34
Value	5.5 (2.6)	3.9 (3.3)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 34 (0%)	0 of 34 (0%)	Not reported
Infrapatellar Nerve Block	0 of 34 (0%)	0 of 34 (0%)	Not reported

Limitations and caveats (from the sponsor): outpatient nature and self reporting of outcome measures

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18574578Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.
Background: PubMed 17005509Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.
Background: PubMed 3344881Arthornthurasook A, Gaew-Im K. Study of the infrapatellar nerve. Am J Sports Med. 1988 Jan-Feb;16(1):57-9. doi: 10.1177/036354658801600110.

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.

Gordon Nuber, MD principal investigator

Northwestern University

Antoun Nader, MD study director

Northwestern University

Lawrence Hsu, MD study director

Northwestern 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 0.25% Bupivacaine and Normal Saline in people with Internal Derangement of Knee, run by Northwestern 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 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 12 May 2014. 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. Some participants in this study may receive a placebo. 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 12 May 2014). 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?

Post op Pain Score (time frame: 0 hours). 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 NCT01279447, which also lists 3 linked publications.

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 12 May 2014.