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Completed

NCT Number: NCT01571492

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L2 Paravertebral catheter nerve block

Procedure

A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.

Continuous Lumbar plexus nerve block

Procedure

A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.

Primary outcomes

  1. Postoperative Opiate consumption

    Time frame: 24 postoperatively

    Postoperative Opiate consumption will be recorded as Morphine IV mg equivalent, for the first 24 hours.

Secondary outcomes

  1. NRS Pain Score (at rest)

    Time frame: 24 and 48 hours postoperatively

    Pain scores at Rest will be recorded at 24 and 48 Hours

  2. NRS Pain Score during physical therapy

    Time frame: 24 and 48 hours postoperatively

    Pain scores at Rest and During physical therapy will be recorded at 24 and 48 Hours

  3. TUG (Timed Up and Go)

    Time frame: 24 hours postoperatively

    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.

  4. Straight Leg Raise(SLR)

    Time frame: 24 hours postoperatively

    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.

  5. Long arc quad (LAQ)

    Time frame: 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty

Important dates

Study start
2009
Primary completion
2010
Study completion
2015
First posted
Apr 5, 2012
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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