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

NCT01571492 | Completed

• 1 other identifier: PRO09010511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Hip Arthroplasty

Keywords

Postoperative Pain; Nerve block; Total Hip Arthroplasty; Postoperative analgesia; Lumbar Plexus Catheters; L2 Paravertebral Catheters

Outcome Measures

Primary Outcomes (1)

• Postoperative Opiate consumption

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

  24 postoperatively

Secondary Outcomes (5)

• NRS Pain Score (at rest)

  24 and 48 hours postoperatively

• NRS Pain Score during physical therapy

  24 and 48 hours postoperatively

• TUG (Timed Up and Go)

  24 hours postoperatively

• Straight Leg Raise(SLR)

  24 hours postoperatively

• Long arc quad (LAQ)

  24 hours postoperatively

Study Arms (2)

L2 Paravertebral peripheral nerve block

EXPERIMENTAL

L2 paravertebral peripheral nerve block catheter will be placed.

Procedure: L2 Paravertebral catheter nerve block

Continuous Lumbar plexus peripheral nerve block

ACTIVE COMPARATOR

Continuous unilateral lumbar plexus peripheral nerve block catheter will be placed.

Procedure: Continuous Lumbar plexus nerve block

Interventions

L2 Paravertebral catheter nerve block PROCEDURE

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

L2 Paravertebral peripheral nerve block

Continuous Lumbar plexus nerve block PROCEDURE

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

Continuous Lumbar plexus peripheral nerve block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (11)

• Marino J, Russo J, Kenny M, Herenstein R, Livote E, Chelly JE. Continuous lumbar plexus block for postoperative pain control after total hip arthroplasty. A randomized controlled trial. J Bone Joint Surg Am. 2009 Jan;91(1):29-37. doi: 10.2106/JBJS.H.00079.

  PMID: 19122076 BACKGROUND

• Lee EM, Murphy KP, Ben-David B. Postoperative analgesia for hip arthroscopy: combined L1 and L2 paravertebral blocks. J Clin Anesth. 2008 Sep;20(6):462-5. doi: 10.1016/j.jclinane.2008.04.012.

  PMID: 18929290 BACKGROUND

• Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.

  PMID: 12032037 BACKGROUND

• Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.

  PMID: 17961837 BACKGROUND

• Chudinov A, Berkenstadt H, Salai M, Cahana A, Perel A. Continuous psoas compartment block for anesthesia and perioperative analgesia in patients with hip fractures. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):563-8. doi: 10.1016/s1098-7339(99)90050-0.

  PMID: 10588563 BACKGROUND

• Kaloul I, Guay J, Cote C, Fallaha M. The posterior lumbar plexus (psoas compartment) block and the three-in-one femoral nerve block provide similar postoperative analgesia after total knee replacement. Can J Anaesth. 2004 Jan;51(1):45-51. doi: 10.1007/BF03018546.

  PMID: 14709460 BACKGROUND

• Farny J, Drolet P, Girard M. Anatomy of the posterior approach to the lumbar plexus block. Can J Anaesth. 1994 Jun;41(6):480-5. doi: 10.1007/BF03011541.

  PMID: 8069987 BACKGROUND

• Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.

  PMID: 18719448 BACKGROUND

• Mannion S, O'Callaghan S, Walsh M, Murphy DB, Shorten GD. In with the new, out with the old? Comparison of two approaches for psoas compartment block. Anesth Analg. 2005 Jul;101(1):259-64, table of contents. doi: 10.1213/01.ANE.0000153866.38440.43.

  PMID: 15976242 BACKGROUND

• Williams BA, Murinson BB. Diabetes mellitus and subclinical neuropathy: a call for new paths in peripheral nerve block research. Anesthesiology. 2008 Sep;109(3):361-2. doi: 10.1097/ALN.0b013e3181829f0d. No abstract available.

  PMID: 18719433 BACKGROUND

• Zink W, Sinner B, Zausig Y, Graf BM. [Myotoxicity of local anaesthetics: experimental myth or clinical truth?]. Anaesthesist. 2007 Feb;56(2):118-27. doi: 10.1007/s00101-006-1121-5. German.

  PMID: 17235544 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 5, 2012
• Study Start: June 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: June 1, 2015
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

US (1)