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

Study Overview
=================
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.

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.

Official Title
-----------------
Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty: A Non-inferiority Trial

Conditions
-----------------
Osteoarthritis, Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Other: LPB
* Other: QLB


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LPB Unilateral DAA THA<br>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. | Other: LPB<br>* 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).<br>* Other names: Lumbar Plexus Block;|
| Experimental: QLB Unilateral DAA THA<br>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. | Other: QLB<br>* 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).<br>* Other names: Quadratus Lumborum Block;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS)) | Quantified on an 10 point pain scale with 0 representing no pain and 10 representing worst pain imaginable. Higher scores denotes worse outcomes. | 6 hours post block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic | Time from PACU discharge to first requested analgesic | During hospitalization, up to 24hrs | 
| Total opioid consumption over 24 hours | Total opioid consumption in the first 24hrs | 24 hrs post block | 
| Verbal numeric pain score at 6hrs at rest (NRS) | Quantified on an 10 point pain scale with 0 representing no pain and 10 representing worst pain imaginable. Higher scores denotes worse outcomes. | 6hrs post block | 
| Verbal numeric pain score at rest and with movement at 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. | 24hrs post block | 
| Ability to straight leg raise on POD1 | Is the patient able to perform an unassisted straight leg raise | Post operative day 1 | 
| Rates of opioid related side effects (nausea, vomiting, pruritis) | Has the patient had any nausea, vomiting, or pruritis within the first 24hrs | Within 24hrs post block | 
| Patient satisfaction utilizing a Likert-scale questionnaire | A patient satisfaction survey to administered on post operative day 1 | Post operative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Plexus Block, Quadratus Lumborum Block, Direct Anterior Approach, Post-Operative, Pain Management