Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement
The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty
1 other identifier
interventional
105
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Typical duration for not_applicable
1 active site
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, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 4, 2011
CompletedAugust 4, 2011
August 1, 2009
11 months
August 2, 2011
August 3, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
The pain medication requirement for 48 hours after surgery in three groups.
48 hours after surgery
Secondary Outcomes (1)
Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
48 hours after surgery
Study Arms (3)
Ropivacaine infiltration and infusion.
EXPERIMENTALRopivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.
Ropivacaine and Saline
EXPERIMENTALRopivicaine infiltration followed by normal saline infusion.
Saline infiltration and infusion.
PLACEBO COMPARATORNormal saline infiltration followed by saline infusion.
Interventions
50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.
50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour
Eligibility Criteria
You may qualify if:
- total knee replacement
You may not qualify if:
- History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Sinha, M.D.
Saint Francis Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 4, 2011
Study Start
August 1, 2009
Primary Completion
July 1, 2010
Study Completion
June 1, 2011
Last Updated
August 4, 2011
Record last verified: 2009-08