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Completed

NCT Number: NCT03408483

Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

Peripheral nerve blocks for joint and extremity surgeries have long been proven to provide effective post-operative analgesia. Of these surgeries, total hip arthroplasty (THA) remains one of the most common orthopedic procedures in the United States with approximately 300,000 operations performed annually. At our institution, post-operative analgesia in these patients is primarily provided through parenteral and oral opioid medications. Quadratus lumborum blocks (QLB) have been described and implemented for various surgical procedures including caesarean and laparoscopic ovarian surgery. Recently, there has been increasing interest in the efficacy of quadratus lumborum blocks for THA. Currently, case reports have established a precedent regarding the efficacy of the QLB for THA in providing superior analgesia and decreasing visual analog pain scores (VAS), but randomized trials are still lacking. The goal of this study is to compare pain scores (VAS), opioid consumption, physical therapy scores, and patient and surgeon satisfaction in patients that receive QLB versus no peripheral nerve blockade in patients undergoing THA. The results of this study have the potential to change standard of care for patients undergoing THA.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

Currently, regional anesthesia techniques for total hip arthroplasty are limited. Fascia iliac blocks have been employed to provide analgesia for hip surgeries with blockade of the femoral, lateral femoral cutaneous, and obturator nerves via injection of local anesthetic in the iliacus fascia. In addition, lumbar plexus blocks have also been employed for post-operative analgesia, but the complexity of the block is high, and complications including epidural anesthesia are not infrequent. The quadratus lumborum block is an abdominal truncal block in which local anesthetic is deposited into the thoracolumbar fascia or the quadratus lumborum muscle itself with the goal of providing analgesia to the ipsilateral T6 - L1 sensory dermatomes. It has already been demonstrated to provide effective post-operative analgesia for certain abdominal and pelvic surgeries, but its use in total hip arthroplasty is limited to case reports.

The block is accomplished by identifying the quadratus lumborum muscle, which originates from iliac crest and iliolumbar ligament, and inserted on transverse processes of upper four lumbar vertebrae and posterior border of the 12th rib. Local anesthetic is then deposited at the anterior, posterior or middle thoracolumbar fascia, or intramuscularly, depending on the technique used. Cadaveric studies8 have demonstrated dye spread to the lumbar nerve roots and nerves within the transversus abdominis plane (TAP). Carney et al9 described a "posterior TAP" block, now known to be synonymous with QLB, that demonstrated contrast spread to the thoracic paravertebral space from T5-L1. Case reports have described analgesia in the corresponding sensory dermatomes after QLB4, and have demonstrated efficacy in patient undergoing THA. The QLB block has potential to cover lateral femoral cutaneous nerve, femoral nerve, obturator nerve and portions of lumbar plexus.

This study has been designed to investigate the efficacy of the quadratus lumborum block as a primary method of providing post-operative analgesia in patients undergoing THA. Previous trials have demonstrated the effectiveness of the block for abdominal and pelvic surgeries, and case reports have shown its applicability in hip arthroplasty. In this randomized controlled study we aim to compare QLB (intervention) with control (no intervention) group in patients undergoing THA with regard to the VAS pain scores (at PACU arrival & discharge12, 24 & 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing total hip arthroplasty
  • Adults 18 years of age and older
  • Patients with an American Society of Anesthesiology (ASA) physical status classification of I, II or III

Exclusion criteria

  • Patients with ASA physical status classification other than I, II, or III
  • Patients with allergies/intolerances to local anesthetic
  • Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
  • Patients with coexisting coagulopathy
  • Patients that are pharmacologically anticoagulated will be excluded if placement of peripheral nerve block would be contraindicated according to ASRA (American Society for Regional Anesthesia) guidelines or if spinal anesthesia would be contraindicated according to guidelines

Treatment and study plan

Quadratus Lumborum Block (QLB)

Drug

Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic.

Other names: bolus, bupivacaine, epinephrine, aliquots

Standard of care

Drug

This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.

Other names: parenteral opioid, oral opioid

Primary outcomes

  1. Pain Scores Using Visual Analog Scale (VAS) Scores

    Time frame: Assessed between immediately postoperatively to 12 hours postoperatively

    The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:

    Rating - Pain Level

    0 - No Pain

    1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)

    4-6 - Moderate Pain (interferes significantly with ADLs)

    7-10 - Severe Pain (disabling; unable to perform ADLs)

    *ADL=Activities of Daily Living

  2. Pain Scores Using Visual Analog Scale (VAS) Scores

    Time frame: Assessed between immediately postoperatively to 24 hours postoperatively

    The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:

    Rating - Pain Level

    0 - No Pain

    1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)

    4-6 - Moderate Pain (interferes significantly with ADLs)

    7-10 - Severe Pain (disabling; unable to perform ADLs)

    *ADL=Activities of Daily Living

  3. Pain Scores Using Visual Analog Scale (VAS) Scores

    Time frame: Assessed between immediately postoperatively to 48 hours postoperatively

    The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:

    Rating - Pain Level

    0 - No Pain

    1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)

    4-6 - Moderate Pain (interferes significantly with ADLs)

    7-10 - Severe Pain (disabling; unable to perform ADLs)

    *ADL=Activities of Daily Living

  4. Opioid Consumption (Oral Morphine Equivalents)

    Time frame: from 24 hours to 48 hours postoperatively

    Total oral morphine equivalent consumption calculated

  5. Opioid Consumption (Oral Morphine Equivalents)

    Time frame: immediately postoperatively to 24 hours postoperatively

    Total oral morphine equivalent consumption calculated

  6. Opioid Consumption (Oral Morphine Equivalents)

    Time frame: immediately postoperatively to 48 hours postoperatively

    Total oral morphine equivalent consumption calculated

  7. Pain Scores Using Visual Analog Scale (VAS) Scores

    Time frame: Immediately postoperatively to 12 hours postoperatively

    The Visual Analogue Scale (VAS) is a psychometric response scale which is used in surveys/questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.

    The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. It is for adults and children 10 years old or older:

    Rating - Pain Level

    0 - No Pain

    1-3 - Mild Pain (nagging, annoying, interfering little with *ADLs)

    4-6 - Moderate Pain (interferes significantly with ADLs)

    7-10 - Severe Pain (disabling; unable to perform ADLs)

    *ADL=Activities of Daily Living

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 24 hours

    Patient Satisfaction Score:

    Determined by patient interview conducted at the 24 hour Time Frame.

    The interview follows a script requesting current pain level based on a scale of 1-10:

    1 = very not satisfied 10 = very satisfied

    Patient satisfaction is subjective.

  2. Hours to Hospital Discharge

    Time frame: Maximum 96 Hours

    From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.

  3. Distance Ambulated

    Time frame: 48 hours

    Physical therapist documentation of ambulation distance measured in feet

  4. Distance Ambulated

    Time frame: 24 hours

    Physical therapist documentation of ambulation distance measured in feet

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 24, 2018
Registry last updated
Jun 9, 2021

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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