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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Total Hip Arthroplasty
• Intervention / Treatment: Other: LPB; Other: QLB

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
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Other: 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 Names: 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.	Other: 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 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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Christopher J Edwards, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): November 22, 2019

Study Registration Dates

• First Submitted: January 18, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pain Management; Quadratus Lumborum Block; Direct Anterior Approach; Post-Operative; Lumbar Plexus Block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: IRB00048845

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No