NCT00314457

Brief Summary

The aim of this study is to determine whether the continuous intraarticular infusion of local anesthetics in the postoperative period can improve analgesia and patients satisfaction after knee and shoulder arthroscopy.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

April 12, 2006

Last Update Submit

July 10, 2009

Conditions

ACL RepairMeniscectomyBankart Repair

Keywords

pain controlintra-articular pain control deviceACL repairBankart Repair

Outcome Measures

Primary Outcomes (1)

  • To evaluate the total amount of opioids and other analgesic medications consumed in the recovery room and during the 48 hour study period (intravenous and oral).

    48 hour post operatively

Secondary Outcomes (1)

  • Secondary endpoints will include the incidence of side effects, such as nausea, vomiting, sedation and itching, pain scores at defined time periods and patients' satisfaction.

    48 hours post operatively

Interventions

BupivacaineDRUG

Patients receive either normal saline or Bupivacaine in normal saline that infuses intraarticularly for 48 hours.

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children between the ages of 11 and 19 years old.
  • Knee and shoulder arthroscopy procedures

You may not qualify if:

  • Contraindications to Femoral-Interscalene Nerve Block
  • Conditions that affect the proper evaluation of pain and side effects.
  • Intake of NSAIDs or opioids in the 12 hours prior to the operation
  • Allergy to study medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Harshad Gurnaney, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

August 1, 2005

Primary Completion

February 1, 2007

Study Completion

April 1, 2009

Last Updated

July 13, 2009

Record last verified: 2009-07

Locations

US(1)