ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 25 for:    Recruiting, Not yet recruiting, Available Studies | "Sterilization, Reproductive"

Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03408483
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Promil Kukreja, University of Alabama at Birmingham

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Drug: Quadratus Lumborum Block (QLB) Drug: Standard of Care Phase 2 Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 & dischage,12, 24 & 36 hours), duration of analgesia, time to first opioid medication, physical therapy evaluations, time to discharge, and surgeon and patient satisfaction scores.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2021

Arm Intervention/treatment
Experimental: quadratus lumborum block (QLB)
  • Patients will be placed in the lateral decubitus position w/non-operative side recumbent. Pillow or blankets will be placed btw patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
  • Standard skin sterilization, prepping and draping will be applied to the area. Under ultrasound guidance, needle will be advanced to posterior border of 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.
  • After QLB is placed, patients will have THA under spinal anesthesia.
Drug: Quadratus Lumborum Block (QLB)
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

Active Comparator: Standard of Care
  • Patients will be placed in the lateral decubitus position with non-operative side recumbent. A pillow or blankets placed between patient's lower extremities. Standard noninvasive monitors applied, and oxygen administered via nasal cannula. Parenteral midazolam and fentanyl titrated to patient comfort.
  • Standard skin sterilization, prepping and draping applied to the area. Ultrasound probe used to identify quadratus lumborum muscle. No local anesthetic injected.
Drug: Standard of Care
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 Outcome Measures :
  1. Pain Scores using Visual Analog Scale (VAS) Scores [ Time Frame: Immediately 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: At 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: At 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. Pain Scores using Visual Analog Scale (VAS) Scores [ Time Frame: At the highest pain point 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


  5. Opioid consumption (oral morphine equivalents) [ Time Frame: Intraoperatively ]
    A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.

  6. Opioid consumption (oral morphine equivalents) [ Time Frame: 24 hours ]
    A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.

  7. Opioid consumption (oral morphine equivalents) [ Time Frame: 48 hours ]
    A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots A bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots.

  8. Physical Therapist Assessment [ Time Frame: 24 hours ]
    Physical therapist assessment of independence in mobility and transfers (independent, with minimal supervision, with moderate supervision, with maximal supervision)

  9. Physical Therapist Assessment [ Time Frame: 48 hours ]
    Physical therapist assessment of independence in mobility and transfers (independent, with minimal supervision, with moderate supervision, with maximal supervision)

  10. Distance Ambulated [ Time Frame: 24 hours ]
    Physical therapist documentation of ambulation distance measured in feet

  11. Distance Ambulated [ Time Frame: 48 hours ]
    Physical therapist documentation of ambulation distance measured in feet


Secondary Outcome Measures :
  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 = no pain

    10 = worst pain imaginable

    Patient satisfaction is subjective.


  2. Patient Satisfaction [ Time Frame: 48 hours ]

    Patient Satisfaction Score:

    Determined by patient interview conducted at the 48 hour Time Frame.

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

    1 = no pain

    10 = worst pain imaginable

    Patient satisfaction is subjective.


  3. Surgeon Satisfaction [ Time Frame: 24 hours ]

    Surgeon Satisfaction Score:

    Based on a scale of 1-10:

    1 = extremely dissatisfied

    10 = extremely satisfied

    Derived from the patient satisfaction interview at the 24 hour time frame, surgeon notes her/his satisfaction with the patient's postoperative pain control and notes her/his assessment as to whether patient experienced motor weakness secondary to block placement that impacted his or her recovery

    Surgeon satisfaction is subjective.


  4. Surgeon Satisfaction [ Time Frame: 48 hours ]

    Surgeon Satisfaction Score:

    Based on a scale of 1-10:

    1 = extremely dissatisfied

    10 = extremely satisfied

    Derived from the patient satisfaction interview at the 48 hour time frame, surgeon notes her/his satisfaction with the patient's postoperative pain control and notes her/his assessment as to whether patient experienced motor weakness secondary to block placement that impacted his or her recovery

    Surgeon satisfaction is subjective.


  5. Hours to Hospital Discharge [ Time Frame: Maximum 3 Hours ]
    From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with ASA physical status classification other than I, II, or III
  2. Patients with allergies/intolerances to local anesthetic
  3. Patients with pre-existing neurologic or anatomic deficits in the lower extremity on the side of the surgical site
  4. Patients with coexisting coagulopathy
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408483


Contacts
Contact: Promil Kukreja, MD, PhD 205-934-4696 pkukreja@uab.edu
Contact: Betty Herard, MBA MA 205-934-0045 herardb@uabmc.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Promil Kukreja, MD, PhD    205-934-4696    pkukreja@uab.edu   
Contact: Cindy Louderback    205-975-9732    clouderback@uab.edu   
Sub-Investigator: Brian D Dishong, MD         
Sub-Investigator: Brandon S Brooks, MD         
Sub-Investigator: Elizabeht B Driscoll, MD         
Sub-Investigator: Ashish Shah, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Promil Kukreja, MD, PhD UAB Department of Anesthesiology, Critical Care Division

Responsible Party: Promil Kukreja, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03408483     History of Changes
Other Study ID Numbers: 300000836
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Promil Kukreja, University of Alabama at Birmingham:
Quadratus Lumborum Block

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents