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Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

This study has been completed.
Sponsor:
Information provided by:
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01409278
First received: August 2, 2011
Last updated: August 3, 2011
Last verified: August 2009
History of Changes
  Purpose

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

Condition Intervention
Osteoarthritis
 Procedure: Ropivacaine infiltration and saline infusion.
Procedure: Ropivacaine infiltration and infusion.
Procedure: Normal Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • The pain medication requirement for 48 hours after surgery in three groups. [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain scores, incidence of nausea and vomiting and patient satisfaction in each group. [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ropivacaine infiltration and infusion.
Ropivicaine infiltration followed by continuous ropivicaine infusion for 48 hours.
 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.
Experimental: Ropivacaine and Saline
Ropivicaine infiltration followed by normal saline infusion.
 Procedure: Ropivacaine infiltration and saline infusion.
50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
Placebo Comparator: Saline infiltration and infusion.
Normal saline infiltration followed by saline infusion.
 Procedure: Normal Saline
50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409278

Locations
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Sanjay Sinha, M.D. Saint Francis Memorial Hospital
  More Information

No publications provided

Responsible Party: Sanjay Sinha, Saint Francis Hospital
ClinicalTrials.gov Identifier: NCT01409278     History of Changes
Other Study ID Numbers: 09-07-002
Study First Received: August 2, 2011
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics, Local
Ropivacaine
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