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

This study has been completed.
Sponsor:
Information provided by:
Northwell Health
ClinicalTrials.gov Identifier:
NCT00790179
First received: November 12, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose
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 Intervention
Postoperative Pain Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Continuous Lumbar Plexus Block for Postoperative Pain Control After Total Hip Arthroplasty

Further study details as provided by Northwell Health:

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

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

Enrollment: 225
Study Start Date: January 2003
Study Completion Date: March 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Detailed Description:
above may be applied
  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 12, 2008
Last Updated: November 12, 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

ClinicalTrials.gov processed this record on July 27, 2017