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Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty

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.
ClinicalTrials.gov Identifier: NCT00790179
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Continuous lumbar plexus and femoral blocks have been demonstrated to provide effective postoperative analgesia of the lower extremity following total joint arthroplasty. The purpose of this study was to compare these two techniques when used with intravenous patient-controlled analgesia and the use of patient-controlled analgesia alone for postoperative pain management following unilateral total hip arthroplasty.

Condition or disease Intervention/treatment
Postoperative Pain Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

Detailed Description:
above may be applied

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty
Study Start Date : January 2003
Primary Completion Date : January 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: PCA;active comparator
Patients with intravenous PCA hydromorphone alone
Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.

Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.

Active Comparator: CFB
Patients with a continuous femoral block (CFB) + PCA hydromorphone
Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.

Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.

Active Comparator: CLPB
Patients with a continuous lumbar plexus block + PCA hydromorphone
Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

0.5% Ropivacaine bolus of 30 ml. followed by ropivacaine 0.2%at 10 ml/hr via CLPB vs. CFB.

Hydromorphone 0.3 mg demand only every 10 minutes via IV PCA.



Outcome Measures

Primary Outcome Measures :
  1. VAS pain scores [ Time Frame: at 24 and 48 hours ]

Secondary Outcome Measures :
  1. hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects [ Time Frame: at 24 and 48 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years old
  • primary diagnosis of osteoarthritis

Exclusion Criteria:

  • allergy to local anesthetics
  • peripheral neuropathy
  • opioid dependency
  • dementia
  • coagulopathy
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): NCT00790179


Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Joseph Marino, M.D. Huntington Hospital
More Information

Responsible Party: Joseph Marino M.D., Huntington Hospital, North Shore-LIJ Health System
ClinicalTrials.gov Identifier: NCT00790179     History of Changes
Other Study ID Numbers: 1989md
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008

Keywords provided by Northwell Health:
Continuous lumbar plexus,Femoral,hydromorphone

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Hydromorphone
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics