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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

Detailed Description

above may be applied

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-80 years old
• primary diagnosis of osteoarthritis

Exclusion Criteria:

• allergy to local anesthetics
• peripheral neuropathy
• opioid dependency
• dementia
• coagulopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS pain scores	at 24 and 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects	at 24 and 48 hours

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: Joseph Marino, M.D., Huntington Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: November 12, 2008
• First Submitted That Met QC Criteria: November 12, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Estimate): November 13, 2008
• Last Update Submitted That Met QC Criteria: November 12, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Continuous lumbar plexus,Femoral,hydromorphone
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 1989md

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No