NCT01279447

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
9 months until next milestone

Results Posted

Study results publicly available

May 12, 2014

Completed
Last Updated

May 12, 2014

Status Verified

January 1, 2014

Enrollment Period

2.6 years

First QC Date

January 17, 2011

Results QC Date

December 5, 2013

Last Update Submit

April 14, 2014

Conditions

Internal Derangement of Knee

Keywords

infrapatellar nervesaphenous nerveknee arthroscopynerve block

Outcome Measures

Primary Outcomes (1)

  • Post op Pain Score

    immediate postop pain score, Visual Analog Scale. Evaluates pain on scale from 0-10. 0=no pain. 10=maximum pain.

    0 hours

Study Arms (2)

Placebo

SHAM COMPARATOR

A sham infrapatellar block performed under US guidance with normal saline

Drug: Normal Saline

Infrapatellar nerve block

EXPERIMENTAL

An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine

Drug: 0.25% Bupivacaine

Interventions

0.25% BupivacaineDRUG

10cc, single dose, US guided injection

Also known as: Nerve block
Infrapatellar nerve block
Normal SalineDRUG

10cc, single dose, US guided injection

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olson Surgical Pavilion

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

  • 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.

    PMID: 18574578BACKGROUND

  • 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.

    PMID: 17005509BACKGROUND

  • 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.

    PMID: 3344881BACKGROUND

MeSH Terms

Interventions

BupivacaineNerve BlockSaline Solution

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, OperativeCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

outpatient nature and self reporting of outcome measures

Results Point of Contact

Title
Lawrence Hsu, MD
Organization
Northwestern
larryphsu@gmail.com
312 9262000

Study Officials

  • Gordon Nuber, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

  • Antoun Nader, MD

    Northwestern University

    STUDY DIRECTOR

  • Lawrence Hsu, MD

    Northwestern University

    STUDY DIRECTOR

  • Mark Kendall, MD

    Northwestern University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 17, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 12, 2014

Results First Posted

May 12, 2014

Record last verified: 2014-01

Locations

US(1)