Clinical trial NCT03408483: Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Official title: Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Total Hip Arthroplasty
Keywords: Quadratus Lumborum Block
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Scores Using Visual Analog Scale (VAS) Scores
timeFrame: Assessed between immediately postoperatively to 12 hours postoperatively
measure: Pain Scores Using Visual Analog Scale (VAS) Scores
timeFrame: Assessed between immediately postoperatively to 24 hours postoperatively
measure: Pain Scores Using Visual Analog Scale (VAS) Scores
timeFrame: Assessed between immediately postoperatively to 48 hours postoperatively
measure: Opioid Consumption (Oral Morphine Equivalents)
timeFrame: from 24 hours to 48 hours postoperatively
measure: Opioid Consumption (Oral Morphine Equivalents)
timeFrame: immediately postoperatively to 24 hours postoperatively
measure: Opioid Consumption (Oral Morphine Equivalents)
timeFrame: immediately postoperatively to 48 hours postoperatively
measure: Pain Scores Using Visual Analog Scale (VAS) Scores
timeFrame: Immediately postoperatively to 12 hours postoperatively
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 24 hours
measure: Hours to Hospital Discharge
timeFrame: Maximum 96 Hours
measure: Distance Ambulated
timeFrame: 48 hours
measure: Distance Ambulated
timeFrame: 24 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: UAB Department of Anesthesiology, Critical Care Division
name: Promil Kukreja, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kukreja P, MacBeth L, Sturdivant A, Morgan CJ, Ghanem E, Kalagara H, Chan VWS. Anterior quadratus lumborum block analgesia for total hip arthroplasty: a randomized, controlled study. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100804. doi: 10.1136/rapm-2019-100804. Online ahead of print.