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

NCT03409900 | Completed

• 1 other identifier: IRB00048845
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Total Hip Arthroplasty

Keywords

Lumbar Plexus Block; Quadratus Lumborum Block; Direct Anterior Approach; Post-Operative; Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time to first analgesic

  During hospitalization, up to 24hrs

• Total opioid consumption over 24 hours

  24 hrs post block

• Verbal numeric pain score at 6hrs at rest (NRS)

  6hrs post block

• Verbal numeric pain score at rest and with movement at 24hrs post block

  24hrs post block

• Ability to straight leg raise on POD1

  Post operative day 1

Study Arms (2)

LPB Unilateral DAA THA

EXPERIMENTAL

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

QLB Unilateral DAA THA

EXPERIMENTAL

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

Interventions

LPB OTHER

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).

Also known as: Lumbar Plexus Block

LPB Unilateral DAA THA

QLB OTHER

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).

Also known as: Quadratus Lumborum Block

QLB Unilateral DAA THA

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Agnosia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher J Edwards, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: March 4, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: May 12, 2020

Record last verified: 2020-03

Locations

US (1)