Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

NCT ID: NCT03408483

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-08-22

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 anterior border of quadratus lumborum muscle. After negative aspiration, a bolus of 30 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.

Group Type: EXPERIMENTAL

Quadratus Lumborum Block (QLB)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

bolus; bupivacaine; epinephrine; aliquots; parenteral opioid; oral opioid

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Promil Kukreja

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Promil Kukreja, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UAB Department of Anesthesiology, Critical Care Division

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31653800 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

300000836

Identifier Type: -

Identifier Source: org_study_id