Total Hip ArthroplastyNCT01571492

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

A study testing L2 Paravertebral catheter nerve block and Continuous Lumbar plexus nerve block in people with Total Hip Arthroplasty, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Total Hip Arthroplasty
What is being tested?: L2 Paravertebral catheter nerve block and Continuous Lumbar plexus nerve block
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jun 2009to Jun 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia After 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.

Read the 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
Being tested: L2 Paravertebral catheter nerve block, Continuous Lumbar plexus nerve block
Keywords: Postoperative Pain, Nerve block, Total Hip Arthroplasty, Postoperative analgesia, Lumbar Plexus Catheters, L2 Paravertebral Catheters
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

L2 Paravertebral catheter nerve blockProcedure or surgery
A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.
Continuous Lumbar plexus nerve blockProcedure or surgery
A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.

Study groups in NCT01571492
Study group	Role	What they receive
L2 Paravertebral peripheral nerve block	Experimental	L2 paravertebral peripheral nerve block catheter will be placed. Receives: 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. Receives: Procedure: Continuous Lumbar plexus nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (5)

NRS Pain Score (at rest)
Pain scores at Rest will be recorded at 24 and 48 Hours
Measured: 24 and 48 hours postoperatively
NRS Pain Score during physical therapy
Pain scores at Rest and During physical therapy will be recorded at 24 and 48 Hours
Measured: 24 and 48 hours postoperatively
TUG (Timed Up and Go)
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.
Measured: 24 hours postoperatively
Straight Leg Raise(SLR)
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.
Measured: 24 hours postoperatively
Long arc quad (LAQ)
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.
Measured: 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009Jun 2015

First posted5 Apr 2012 (estimated)
Study startJun 2009
Primary completionOct 2010
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01571492
Sponsor's protocol ID: PRO09010511
Status last verified: Jun 2017
First submitted: 2 Apr 2012
Last updated: 7 Jun 2017
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 19122076
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.
PubMed 18929290
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.
PubMed 12032037
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.
PubMed 17961837
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.
PubMed 10588563
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.
PubMed 14709460
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.
PubMed 8069987
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.
PubMed 18719448
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.
PubMed 15976242
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.
PubMed 18719433
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.
PubMed 17235544

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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All Total Hip Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Continuous L2 Paravertebral Block Versus Continuous Lumbar Plexus Block for Postoperative Analgesia After Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01571492
Acronym / sponsor ID: PRO09010511
Conditions: Total Hip Arthroplasty
Keywords: Postoperative Pain, Nerve block, Total Hip Arthroplasty, Postoperative analgesia, Lumbar Plexus Catheters, L2 Paravertebral Catheters
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Study start: Jun 2009
Primary completion: Oct 2010 (actual)
Study completion: Jun 2015 (actual)
First posted: 5 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
L2 Paravertebral peripheral nerve block	Experimental	Procedure: L2 Paravertebral catheter nerve blockL2 paravertebral peripheral nerve block catheter will be placed.
Continuous Lumbar plexus peripheral nerve block	Active comparator	Procedure: Continuous Lumbar plexus nerve blockContinuous unilateral lumbar plexus peripheral nerve block catheter will be placed.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
L2 Paravertebral catheter nerve blockA continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.	Procedure or surgery	L2 Paravertebral peripheral nerve block
Continuous Lumbar plexus nerve blockA continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.	Procedure or surgery	Continuous Lumbar plexus peripheral nerve block

Primary outcome

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

5 secondary outcomes

NRS Pain Score (at rest)
Time frame: 24 and 48 hours postoperatively
NRS Pain Score during physical therapy
Time frame: 24 and 48 hours postoperatively
TUG (Timed Up and Go)
Time frame: 24 hours postoperatively
Straight Leg Raise(SLR)
Time frame: 24 hours postoperatively
Long arc quad (LAQ)
Time frame: 24 hours postoperatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
Background: PubMed 19122076Marino 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.
Background: PubMed 18929290Lee 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.
Background: PubMed 12032037Capdevila 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.
Background: PubMed 17961837Siddiqui 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.
Background: PubMed 10588563Chudinov 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.
Background: PubMed 14709460Kaloul 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.
Background: PubMed 8069987Farny 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.
Background: PubMed 18719448Ilfeld 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.
Background: PubMed 15976242Mannion 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.
Background: PubMed 18719433Williams 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.
Background: PubMed 17235544Zink 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.

Related trials for Total Hip Arthroplasty

Not yet recruiting
Comparison of Ultrasound-Guided Erector Spinae Plane Block and Quadro-Iliac Plane Block in Elective Primary Unilateral Total Hip Arthroplasty
Postoperative Pain, Hip Arthroplasty, Total
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing L2 Paravertebral catheter nerve block and Continuous Lumbar plexus nerve block in people with Total Hip Arthroplasty, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Opiate consumption (time frame: 24 postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01571492, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.