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QL vs LP Blocks for Analgesia Following THA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04402437
Recruitment Status : Completed
First Posted : May 26, 2020
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
Sylvia Wilson, Medical University of South Carolina

Brief Summary:

Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty (THA).

Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid consumption following hip arthroplasty.


Condition or disease Intervention/treatment Phase
Surgery Procedure: LP Block Procedure: QL Block Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine.
Masking: Single (Participant)
Masking Description: All subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.
Primary Purpose: Treatment
Official Title: Utilization of Quadratus Lumborum Versus Lumbar Plexus Blocks for Postoperative Analgesia Following Hip Arthroplasty: A Prospective, Randomized Clinical Trial
Actual Study Start Date : July 23, 2020
Actual Primary Completion Date : June 4, 2021
Actual Study Completion Date : June 4, 2021

Arm Intervention/treatment
Active Comparator: Receives LP Block
Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.
Procedure: LP Block
Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.

Active Comparator: Receives QL Block
Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.
Procedure: QL Block
Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 12 hours ]
    Opioid consumption including intraoperative consumption


Secondary Outcome Measures :
  1. Opioid consumption 8 hours postoperative [ Time Frame: 8 hours ]
    Opioid consumption including intraoperative consumption



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years-old
  • Undergoing elective hip arthroplasty.

Exclusion Criteria:

  • Local anesthetic allergy
  • Chlorhexidine allergy
  • Subjects with a weight less than 40kg
  • Subjects that are unable or choose not to give informed consent
  • Emergency surgery
  • Known preoperative substance abuse
  • Allergy to all opioids

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): NCT04402437


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Sylvia H Wilson, MD Medical University of South Carolina
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sylvia Wilson, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04402437    
Other Study ID Numbers: Pro00098482
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No