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Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409278
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Saint Francis Care
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


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 ]

Secondary Outcome Measures:
  • Pain scores, incidence of nausea and vomiting and patient satisfaction in each group. [ Time Frame: 48 hours after surgery ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sanjay Sinha, Saint Francis Hospital
ClinicalTrials.gov Identifier: NCT01409278     History of Changes
Other Study ID Numbers: 09-07-002
First Submitted: August 2, 2011
First Posted: August 4, 2011
Last Update Posted: August 4, 2011
Last Verified: August 2009

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents