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Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03409900
Recruitment Status : Not yet recruiting
First Posted : January 24, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with end stage osteoarthritis. In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA). The literature supports that DAA is superior to PLA with regard to lower blood loss, less pain, shorter hospital stay, and faster rehabilitation. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. This study is designed to compare the efficacy, with regards to post-operative pain management, between LPB and QLB following a DAA total hip arthroplasty.

Condition or disease Intervention/treatment Phase
Osteoarthritis Total Hip Arthroplasty Drug: LPB Drug: QLB Phase 2

Detailed Description:
In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA) in regards to total hip arthroplasty (THA). The DAA technique involves dissection of muscular planes for insertion of components resulting in less tissue damage as compared to PLA. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. This technique works well for the traditionally performed PLA in that the hip joint and incision site are within the analgesic distribution of the LPB. Conversely, the DAA utilizes an anterior incision that overlies the L1 and L2 dermatomes as opposed to the lower lumbar dermatomes of the PLA incision. When performing LPB it has been the study team's clinical experience that it is rare to achieve analgesia in the proximal distribution of the lumbar plexus resulting in apparent sparing of the L1 and L2 nerve root distributions. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. The QLB is thought to provide analgesia by blocking both the lateral and anterior cutaneous branches of T7 through L4. This degree of dermatomal coverage suggests that QLB could be an efficacious alternative to LPB for DAA hip arthroplasty. It is hypothesized that the QLB will provide equivalent analgesia when compared to the LPB as determined by a comparison of verbal reported pain scores.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty: A Non-inferiority Trial
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LPB Unilateral DAA THA
Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.
Drug: LPB
The LPB will be performed in a lateral position, but modified to utilize ultrasound guidance to enhance our ability to quickly and safely locate the lumbar plexus as well as to avoid unblinding with regard to the traditional landmark LPB technique. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
Other Name: Lumbar Plexus Block

Experimental: QLB Unilateral DAA THA
Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.
Drug: QLB
The QLB will be performed in a lateral position in a manner consistent with the technique first described by Børglum. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
Other Name: Quadratus Lumborum Block




Primary Outcome Measures :
  1. Verbal numeric pain score with hip flexion at 8hrs (Numeric Rating Scale (NRS)) [ Time Frame: 8 hours post block ]
    Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.


Secondary Outcome Measures :
  1. Time to first analgesic [ Time Frame: During hospitalization, up to 24hrs ]
    Time from PACU discharge to first requested analgesic

  2. Total opioid consumption over 24 hours [ Time Frame: 24 hrs post block ]
    Total opioid consumption in the first 24hrs

  3. Verbal numeric pain score at 8hrs at rest (NRS) [ Time Frame: 8hrs post block ]
    Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.

  4. Verbal numeric pain score at rest and with movement at 24hrs post block [ Time Frame: 24hrs post block ]
    Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.

  5. Ability to straight leg raise on POD1 [ Time Frame: Post operative day 1 ]
    Is the patient able to perform an unassisted straight leg raise

  6. Rates of opioid related side effects (nausea, vomiting, pruritis) [ Time Frame: Within 24hrs post block ]
    Has the patient had any nausea, vomiting, or pruritis within the first 24hrs

  7. Patient satisfaction utilizing a Likert-scale questionnaire [ Time Frame: Post operative day 1 ]
    A patient satisfaction survey to administered on post operative day 1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient between the ages of 18 and 95 years undergoing a primary elective, unilateral DAA total hip arthroplasty.

Exclusion Criteria:

  • If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations.
  • Indication for surgery is secondary to trauma and/or hip fracture
  • If there is a contraindication to the performance of a regional block
  • Concomitant anticoagulation use or documented coagulopathy
  • Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade
  • Presence of progressive neurologic deficit effecting peripheral nerves
  • Allergy or adverse reaction to study drugs to include: fentanyl, epinephrine, and amide local anesthetics
  • American Society of Anesthesia Physical Classification score > or = to 4
  • Allergies to study drugs other than local anesthetic
  • BMI > 40
  • Patient refusal
  • Pregnancy
  • Institutionalized individuals
  • Extremes of age: Age > 95 or < 18
  • Non English speaking or inability to reliably participate in the study

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): NCT03409900


Contacts
Contact: Christopher J Edwards, MD 3367168222 chedward@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Christopher J Edwards, MD    336-716-8222    chedwards@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Christopher J Edwards, MD Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03409900     History of Changes
Other Study ID Numbers: 1122018
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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

Keywords provided by Wake Forest University Health Sciences:
Lumbar Plexus Block
Quadratus Lumborum Block
Direct Anterior Approach
Post-Operative
Pain Management

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases