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Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Richa Wardhan, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01571492
First received: April 2, 2012
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

This prospective study is intended to compare the analgesic efficacy, preservation of lower extremity motor power and side-effect profile of L2 Paravertebral lumbar plexus approach compared to Posterior nerve stimulation guided lumbar plexus approach, continuous local anesthetic infusion postoperative analgesia of Total Hip Arthroplasty.

The L2 Paravertebral technique of lumbar plexus block, as part of a multimodal pain treatment, could be a cost-effective alternative with a equal profile of analgesic efficacy and motor power sparing with greater promotion of early achievement of postoperative physical therapy goals.


Condition Intervention
Total Hip Arthroplasty
Procedure: L2 Paravertebral catheter nerve block
Procedure: Continuous Lumbar plexus nerve block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Postoperative Opiate consumption [ Time Frame: 24 postoperatively ] [ Designated as safety issue: No ]
    Postoperative Opiate consumption will be recorded as Morphine IV mg equivalent, for the first 24 hours.


Secondary Outcome Measures:
  • NRS Pain Score (at rest) [ Time Frame: 24 and 48 hours postoperatively ] [ Designated as safety issue: No ]
    Pain scores at Rest will be recorded at 24 and 48 Hours

  • NRS Pain Score during physical therapy [ Time Frame: 24 and 48 hours postoperatively ] [ Designated as safety issue: No ]
    Pain scores at Rest and During physical therapy will be recorded at 24 and 48 Hours

  • TUG (Timed Up and Go) [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    The timed get up and go test is a measurement of mobility. It includes a number of tasks such as standing from a seating position, walking, turning, stopping, and sitting down which are all important tasks needed for a person to be independently mobile.

  • Straight Leg Raise(SLR) [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    In supine position with the extremity being tested and contralateral flexed LE with foot flat on surface. Patient is instructed to lift extremity to level of contralateral knee. Inability to lift entire LE off of the surface to the level of the contralateral knee would be indicative of hip flexor weakness. If the patient is able to lift LE off of the surface, however the knee flexes/unable to maintain full knee extension, this is indicative of quad weakness.

  • Long arc quad (LAQ) [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
    In sitting position at the edge of the bed or chair. Patient is asked to extend lower leg fully on side that is being tested. If able, this is indicative that quad function is intact. If unable to fully extend knee, would indicate quad weakness.


Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L2 Paravertebral peripheral nerve block
L2 paravertebral peripheral nerve block catheter will be placed.
Procedure: L2 Paravertebral catheter nerve block
A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.
Active Comparator: Continuous Lumbar plexus peripheral nerve block
Continuous unilateral lumbar plexus peripheral nerve block catheter will be placed.
Procedure: Continuous Lumbar plexus nerve block
A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.

Detailed Description:

The nerve stimulator guided technique of continuous lumbar plexus block (LPB) is the accepted standard of care at University of Pittsburgh Medical Center (UPMC) for the management of postoperative analgesia after Total Hip Arthroplasty. Over 900 continuous lumbar plexus blocks were performed at UPMC Presbyterian Shadyside hospital within the last year alone. Continuous thoracic paravertebral block (TPVB) is also commonly performed at UPMC Presbyterian Shadyside . Over 2000 are performed annually for a wide variety of surgical procedures. Recently authors have suggested that a lumbar paravertebral block (LPVB) may represent an alternative approach to the lumbar plexus. Indeed the L2 paravertebral approach of the lumbar plexus has been described to provide adequate postoperative analgesia following hip arthroscopic surgery. However, to date, there is no prospective direct comparison between L2 Lumbar plexus approach and the posterior approach for postoperative analgesia after Total Hip Arthroplasty.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-75 years
  • No contraindications to placement of a lumbar plexus posterior block or paravertebral block.
  • ASA status I-III
  • Scheduled for open total hip arthroplasty with the same surgeon.
  • Patients without painful conditions or chronic use of opioid or antineuropathic medications.
  • Patient who are not expected to receive therapeutic anticoagulation in the postoperative period.
  • No Known allergies to the medications used in the study.
  • Patients willing to receive spinal anesthesia

Exclusion Criteria:

  • Age under 18 years or older than 75 years.
  • Any contraindication to a placement of continuous lumbar plexus Block.
  • American Society of Anesthesiologist physical status IV or greater.
  • Chronic painful conditions.
  • Preoperative opioid tolerant use.
  • Coagulation Abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively.
  • Allergy to any of the drugs/agents used study protocol.
  • Personal or family history of malignant hyperthermia.
  • Serum creatinine greater than 1.4 mg/dl.
  • Pregnancy
  • Having an altered mental status (not oriented to place, person, or time)
  • Any comorbid condition that, in the judgment of the consulting orthopedic surgeon, or intraoperative anesthesiologist, would proscribe the patient from any aspect of the study.
  • Patient refusal.
  • Lumbar plexus block performed with loss of resistance technique
  • Patient requiring postoperative management in the ICU
  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: NCT01571492

Locations
United States, Pennsylvania
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
  More Information

Publications:

Responsible Party: Richa Wardhan, Principal Investigator and Regional Anesthesia Fellow, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01571492     History of Changes
Other Study ID Numbers: PRO09010511
Study First Received: April 2, 2012
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Postoperative Pain
Nerve block
Total Hip Arthroplasty
Postoperative analgesia
Lumbar Plexus Catheters
L2 Paravertebral Catheters

ClinicalTrials.gov processed this record on November 20, 2014