Quadratus Lumborum Block Versus Control for Total Hip Arthroplasty

NCT03408483 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 300000836
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Arthroplasty

Keywords

Quadratus Lumborum Block

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• Opioid Consumption (Oral Morphine Equivalents)

  Total oral morphine equivalent consumption calculated

  from 24 hours to 48 hours postoperatively

• Opioid Consumption (Oral Morphine Equivalents)

  Total oral morphine equivalent consumption calculated

  immediately postoperatively to 24 hours postoperatively

• Opioid Consumption (Oral Morphine Equivalents)

  Total oral morphine equivalent consumption calculated

  immediately postoperatively to 48 hours postoperatively

• 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 Outcomes (4)

• Patient Satisfaction

  24 hours

• Hours to Hospital Discharge

  Maximum 96 Hours

• Distance Ambulated

  48 hours

• Distance Ambulated

  24 hours

Study Arms (2)

quadratus lumborum block (QLB)

EXPERIMENTAL

* 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.

Drug: Quadratus Lumborum Block (QLB)

Standard of Care

ACTIVE COMPARATOR

* 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

Interventions

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.

Also known as: bolus, bupivacaine, epinephrine, aliquots

quadratus lumborum block (QLB)

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.

Also known as: parenteral opioid, oral opioid

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 31653800 DERIVED

MeSH Terms

Interventions

NOP-bolus regimen; Bupivacaine; Epinephrine; Standard of Care; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Adam Sturdivant
• Organization: UAB

Adamsturdivant@uabmc.edu

205-934-4042

Study Officials

• Promil Kukreja, MD, PhD

  UAB Department of Anesthesiology, Critical Care Division

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 24, 2018
• Study Start: April 1, 2018
• Primary Completion: May 10, 2019
• Study Completion: August 22, 2020
• Last Updated: June 9, 2021
• Results First Posted: September 4, 2020

Record last verified: 2021-05

Locations

US (1)