Back to results

Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ropivacaine infiltration and saline infusion.

Ropivacaine infiltration and infusion.

Normal Saline

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

total knee replacement

Exclusion Criteria:

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

Sites / Locations

Saint Francis Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine infiltration and infusion.

Ropivacaine and Saline

Saline infiltration and infusion.

Arm Description

Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.

Ropivicaine infiltration followed by normal saline infusion.

Normal saline infiltration followed by saline infusion.

Outcomes

Primary Outcome Measures

The pain medication requirement for 48 hours after surgery in three groups.

Secondary Outcome Measures

Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.

Full Information

NCT ID

NCT01409278

First Posted

August 2, 2011

Last Updated

August 3, 2011

Sponsor

Trinity Health Of New England

1. Study Identification

Unique Protocol Identification Number

NCT01409278

Brief Title

Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

Official Title

The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Trinity Health Of New England

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine three different ways to control pain after hip replacement: One time injection of ropivacaine before wound closure One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours Standard practice of patient controlled pump

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine infiltration and infusion.

Arm Type

Experimental

Arm Description

Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.

Arm Title

Ropivacaine and Saline

Arm Type

Experimental

Arm Description

Ropivicaine infiltration followed by normal saline infusion.

Arm Title

Saline infiltration and infusion.

Arm Type

Placebo Comparator

Arm Description

Normal saline infiltration followed by saline infusion.

Intervention Type

Procedure

Intervention Name(s)

Ropivacaine infiltration and saline infusion.

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Ropivacaine infiltration and infusion.

Intervention Description

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

Intervention Name(s)

Normal Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

The pain medication requirement for 48 hours after surgery in three groups.

Time Frame

48 hours after surgery

Secondary Outcome Measure Information:

Title

Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.

Time Frame

48 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: total knee replacement Exclusion Criteria: History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Sinha, M.D.

Organizational Affiliation

Saint Francis Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Francis Hospital and Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

We'll reach out to this number within 24 hrs