Text Size

Infrapatellar Nerve Block for Post-operative Knee Arthroscopy Pain Control

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Larry Hsu, Northwestern University
ClinicalTrials.gov Identifier:
NCT01279447
First received: January 17, 2011
Last updated: April 7, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Knee Pain
Internal Derangement of Knee
Knee Arthroscopy
 Drug: 0.25% Bupivacaine
Drug: Normal Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Infrapatellar Nerve Block for Post-operative Analgesia for Knee Arthroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain (VAS) [ Time Frame: 0-48 hours ] [ Designated as safety issue: No ]
    Pain scores will be recorded hourly from emergence from surgery until discharge home from recovery. Patient will then be asked to record pain scores at various defined intervals up until 48 hours.


Secondary Outcome Measures:
  • Opioid Analgesic Use [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Opioid analgesic use will be recorded intra-op and up until 48 hours after surgery.

  • Nausea [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Postoperative nausea will be assessed until discharge from recovery

  • Mobility [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Time until achieving various goals of mobility will be recorded.

  • Quality of Recovery [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Modified Quality of Recovery Score to be completed at 48 hours

  • Lysholm Knee Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Knee outcome survey

  • Lysholm Knee Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Knee outcome survey


Enrollment: 68
Study Start Date: January 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Placebo
A sham infrapatellar block performed under US guidance with normal saline
 Drug: Normal Saline
10cc, single dose, US guided injection
Experimental: Infrapatellar nerve block
An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
 Drug: 0.25% Bupivacaine
10cc, single dose, US guided injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications to nerve block: eg neuropathy, type 1 diabetes, coagulopathy
  • knee arthroscopy with planned bony intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279447

Locations
United States, Illinois
Olson Surgical Pavilion
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gordon Nuber, MD Northwestern University
Study Director: Antoun Nader, MD Northwestern University
Study Director: Lawrence Hsu, MD Northwestern University
Study Director: Mark Kendall, MD Northwestern University
  More Information

Publications:

Responsible Party: Larry Hsu, Resident, Northwestern University
ClinicalTrials.gov Identifier: NCT01279447     History of Changes
Other Study ID Numbers: STU00026632
Study First Received: January 17, 2011
Last Updated: April 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
infrapatellar nerve
saphenous nerve
knee arthroscopy
nerve block

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013