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Completed

NCT Number: NCT03409900

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

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.

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Lumbar Plexus Block

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).

Other names: Quadratus Lumborum Block

Primary outcomes

  1. Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))

    Time frame: 6 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 outcomes

  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 6hrs at rest (NRS)

    Time frame: 6hrs 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2018
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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