Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408483
• Other study ID #: 300000836
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 1, 2018
• Est. completion date: August 22, 2020

Study information

• Verified date: May 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 22, 2020
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores Using Visual Analog Scale (VAS) Scores	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	Assessed between immediately postoperatively to 12 hours postoperatively
Primary	Pain Scores Using Visual Analog Scale (VAS) Scores	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	Assessed between immediately postoperatively to 24 hours postoperatively
Primary	Pain Scores Using Visual Analog Scale (VAS) Scores	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	Assessed between immediately postoperatively to 48 hours postoperatively
Primary	Opioid Consumption (Oral Morphine Equivalents)	Total oral morphine equivalent consumption calculated	from 24 hours to 48 hours postoperatively
Primary	Opioid Consumption (Oral Morphine Equivalents)	Total oral morphine equivalent consumption calculated	immediately postoperatively to 24 hours postoperatively
Primary	Opioid Consumption (Oral Morphine Equivalents)	Total oral morphine equivalent consumption calculated	immediately postoperatively to 48 hours postoperatively
Primary	Pain Scores Using Visual Analog Scale (VAS) Scores	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	Immediately postoperatively to 12 hours postoperatively
Secondary	Patient Satisfaction	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.	24 hours
Secondary	Hours to Hospital Discharge	From time of the surgical procedure to the time of hospital discharge (measured in hours) up to 3 hours.	Maximum 96 Hours
Secondary	Distance Ambulated	Physical therapist documentation of ambulation distance measured in feet	48 hours
Secondary	Distance Ambulated	Physical therapist documentation of ambulation distance measured in feet	24 hours