NCT00790179

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

4 years

First QC Date

November 12, 2008

Last Update Submit

November 12, 2008

Conditions

Postoperative Pain

Keywords

Continuous lumbar plexus,Femoral,hydromorphone

Outcome Measures

Primary Outcomes (1)

  • VAS pain scores

    at 24 and 48 hours

Secondary Outcomes (1)

  • hydromorphone consumption,patient satisfaction,distance ambulated, opioid-related side effects

    at 24 and 48 hours

Study Arms (3)

PCA;active comparator

ACTIVE COMPARATOR

Patients with intravenous PCA hydromorphone alone

Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

CFB

ACTIVE COMPARATOR

Patients with a continuous femoral block (CFB) + PCA hydromorphone

Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

CLPB

ACTIVE COMPARATOR

Patients with a continuous lumbar plexus block + PCA hydromorphone

Procedure: continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCA

Interventions

continuous infusion of ropivacaine via CLPB vs. CFB vs IV PCAPROCEDURE

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.

CFBCLPBPCA;active comparator

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • primary diagnosis of osteoarthritis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Joseph Marino, M.D.

    Huntington Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

January 1, 2003

Primary Completion

January 1, 2007

Study Completion

March 1, 2007

Last Updated

November 13, 2008

Record last verified: 2008-11