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

NCT ID: NCT01571492

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2015-06-30

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.

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L2 Paravertebral peripheral nerve block

L2 paravertebral peripheral nerve block catheter will be placed.

Group Type: EXPERIMENTAL

L2 Paravertebral catheter nerve block

Intervention Type: PROCEDURE

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

Continuous Lumbar plexus peripheral nerve block

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

Group Type: ACTIVE_COMPARATOR

Continuous Lumbar plexus nerve block

Intervention Type: PROCEDURE

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

Interventions

L2 Paravertebral catheter nerve block

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

Intervention Type: PROCEDURE

Continuous Lumbar plexus nerve block

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jacques E. Chelly

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19122076 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18929290 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12032037 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17961837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10588563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14709460 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8069987 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18719448 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15976242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18719433 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17235544 (View on PubMed)

Other Identifiers

PRO09010511

Identifier Type: -

Identifier Source: org_study_id