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

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

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	Phase
Postoperative Pain	Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA	Not Applicable

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
• Actual Primary Completion Date: January 2007
• Actual Study Completion Date: March 2007

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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 1989md
• First Posted: November 13, 2008
• 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; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents