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Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT03801265
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sharad Khetarpal, University of Pittsburgh

Brief Summary:
The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia technique to provide postoperative pain management after primary hip replacement surgery at UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with potentially serious side effects, including nerve injury, major bleeding, retroperitoneal hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can also lead to motor blockade, interfering with early ambulation. There are several case reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief after total hip replacement surgery, and this QL3 block is performed routinely at this institution. The benefits to inter-fascial administration of local anesthetic include the avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration associated with the direct interaction between the nerve and the nerve block needle. The purpose of this study is to show that QL3 block is non-inferior to the standard-of-care lumbar plexus block and should be used more regularly in hip replacement surgery. The study will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority, active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block for post-operative pain management in subjects undergoing primary, unilateral hip replacement surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and physical therapy response. Primary outcome measures include pain at rest and with movement at 6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by a physical therapist.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Procedure: Lumbar plexus block Procedure: Quadratus lumborum type 3 block Drug: Ropivacaine injection Phase 4

Detailed Description:
Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative area on their day of surgery. The anesthesiology investigator will speak with the patient about the study behind a closed drape and the patient will have adequate time to consider the consent and ask questions regarding risk factors associated with each type of block. Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups. Once assigned the treatment allocation, only the clinician administering the block will be unblinded to the randomization outcome. If randomized to the LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. For both treatment groups, the local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary outcome measures. These include pain at rest and with movement at 6, 12 and 24 hours after surgery, time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by physical therapist. This information will be captured from the patient's electronic medical record.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Lumbar plexus block vs Quadratus lumborum type 3 block
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The person who perform the block will be unblinded. The participants and the outcomes assessor will be blinded to the treatment allocations.
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blinded, Active-comparator, Non-inferiority Study to Observe Relative Efficacy of Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Class Lumbar Plexus Block in Managing Post-operative Pain Following Total Hip Replacement Surgery
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Active Comparator: Lumbar Plexus block
0.5% ropivacaine 100 mg (20 ml) will be injected
Procedure: Lumbar plexus block
Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.

Drug: Ropivacaine injection
0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Experimental: Quadratus Lumborum type 3 block
0.5% ropivacaine 100 mg (20 ml) will be injected
Procedure: Quadratus lumborum type 3 block
Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.

Drug: Ropivacaine injection
0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.




Primary Outcome Measures :
  1. Pain after surgery [ Time Frame: 6 hours after surgery ]
    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest and pain with movement

  2. Pain after surgery [ Time Frame: 12 hours after surgery ]
    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest and pain with movement

  3. Pain after surgery [ Time Frame: 24 hours after surgery ]
    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest and pain with movement


Secondary Outcome Measures :
  1. Total pain medications (narcotics and non-narcotic analgesics) [ Time Frame: 24 hours after surgery ]
    Narcotics will be converted to oral morphine equivalents

  2. Time of participant's ability to walk 100 feet [ Time Frame: within 24 hours after surgery ]
    Duration that patient is able to walk 100 feet after surgery, it will be recorded by physical therapists

  3. Time to first request of opioids [ Time Frame: within 24 hours after surgery ]
    Duration that the patient first request opioid medications after surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18-90 years old
  2. Primary unilateral total hip arthroplasty
  3. BMI 20 - 36
  4. Male and Female
  5. All races

Exclusion Criteria:

  1. Patient refusal
  2. ASA class > or = 4
  3. Pregnancy
  4. Any condition precluding patient going home with in 24 hours of surgery
  5. Non-English speaking or inability to participate in the study
  6. Patients with coagulopathy or on therapeutic anticoagulation
  7. Chronic Steroid Use
  8. Narcotic Addiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801265


Contacts
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Contact: Sharad Khetarpal, MD 4126235020 khetarpalsk@upmc.edu
Contact: Utchariya Anantamongkol 3124591320 anantamongkolu@upmc.edu

Locations
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United States, Pennsylvania
UPMC Presbyterian-Shadyside Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Amy Monroe    412-623-6382    monroeal@upmc.edu   
Sub-Investigator: Utchariya Anantamongkol, MD PhD         
Sub-Investigator: Aby Pynadeth, MD         
Sponsors and Collaborators
Sharad Khetarpal
Investigators
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Principal Investigator: Sharad Khetarpal, MD Department of Anesthesiology, University of Pittsburgh Medical Center

Publications:
Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11

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Responsible Party: Sharad Khetarpal, Clinical Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03801265     History of Changes
Other Study ID Numbers: PRO18120275
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sharad Khetarpal, University of Pittsburgh:
lumbar plexus block
quadratus lumborum block
total hip arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Pain, Postoperative
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents