Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

NCT ID: NCT01409278

Last Updated: 2011-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to examine three different ways to control pain after hip replacement:

1. One time injection of ropivacaine before wound closure
2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
3. Standard practice of patient controlled pump

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine infiltration and infusion.

Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.

Group Type EXPERIMENTAL

Ropivacaine infiltration and infusion.

Intervention Type PROCEDURE

50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.

Ropivacaine and Saline

Ropivicaine infiltration followed by normal saline infusion.

Group Type EXPERIMENTAL

Ropivacaine infiltration and saline infusion.

Intervention Type PROCEDURE

50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour

Saline infiltration and infusion.

Normal saline infiltration followed by saline infusion.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type PROCEDURE

50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour

Interventions

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Ropivacaine infiltration and saline infusion.

50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour

Intervention Type PROCEDURE

Ropivacaine infiltration and infusion.

50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.

Intervention Type PROCEDURE

Normal Saline

50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* total knee replacement

Exclusion Criteria

* History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trinity Health Of New England

OTHER

Sponsor Role lead

Responsible Party

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Saint Francis Hospital

Principal Investigators

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Sanjay Sinha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Locations

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Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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09-07-002

Identifier Type: -

Identifier Source: org_study_id

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