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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

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03801265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • Total pain medications (narcotics and non-narcotic analgesics) [ Time Frame: 24 hours after surgery ]
    Narcotics will be converted to oral morphine equivalents
  • 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
  • Time to first request of opioids [ Time Frame: within 24 hours after surgery ]
    Duration that the patient first request opioid medications after surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2019)
  • Total pain medications (narcotics and non-narcotic analgesics) [ Time Frame: 24 hours after surgery ]
    Narcotics will be converted to oral morphine equivalents
  • Time of participant's ability to walk 100 feet [ Time Frame: within 24h after surgery ]
    Duration that patient is able to walk 100 feet after surgery, it will be recorded by physical therapists
  • Time to first request of opioids [ Time Frame: within 24h after surgery ]
    Duration that the patient first request opioid medications after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Hip Osteoarthritis
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Lumbar Plexus block
    0.5% ropivacaine 100 mg (20 ml) will be injected
    Interventions:
    • Procedure: Lumbar plexus block
    • Drug: Ropivacaine injection
  • Experimental: Quadratus Lumborum type 3 block
    0.5% ropivacaine 100 mg (20 ml) will be injected
    Interventions:
    • Procedure: Quadratus lumborum type 3 block
    • Drug: Ropivacaine injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 9, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sharad Khetarpal, MD 4126235020 khetarpalsk@upmc.edu
Contact: Utchariya Anantamongkol 3124591320 anantamongkolu@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801265
Other Study ID Numbers  ICMJE PRO18120275
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sharad Khetarpal, University of Pittsburgh
Study Sponsor  ICMJE Sharad Khetarpal
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sharad Khetarpal, MD Department of Anesthesiology, University of Pittsburgh Medical Center
PRS Account University of Pittsburgh
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP