Volume Versus Concentration: Clinical Effectiveness of Single Shot Quadrates Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.

Volume Versus Concentration: A Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Single Shot Quadratus Lumborum Block Using Either a High Volume/Low Concentration or Low Volume/High Concentration Injectate for Total Hip Arthroplasty.

There is Controversy about what is more critical volume or concentration to achieve an optimum analgesic treatment with quadratus lumborum block. From the experiences of the authors, the regular dose of 20 ml of Bupivacaine at 0.375% concentration could not be enough in some cases to produce an optimum analgesic treatment, especially in hip arthroplasties. What is proposed in this study is to evaluate whether the volume injected in the quadratus lumborum block is more important than the concentration of the local anesthetic in terms of control of pain during the next 24 hours after surgery and opioid consumption.

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Drug: Drug: Bupivacaine 0.375% diluted to 0.1875%; Drug: Drug: Bupivacaine 0.375% 20 mL

Detailed Description

The Quadratus Lumborum Block (QLB) was originally described by Blanco in 2007 as a posterior variation of the Transversus Abdominis Plane block. It is now, however, recognized as a unique, alternative, and separate interfascial plane block. The QLB has been studied and compared with other types of blocks and it may offer several advantages such as simplicity, safety, and avoidance of hypotension. Additionally, dermatomal coverage may be greater than for other types of blocks. In cadaveric studies the paravertebral spread of dye was found from T7-L5 , although an vivo study in healthy volunteers showed the paravertebral spread of the contrast solution only between T10-L1 at 1 hour after the block. It is noted that while these anatomical studies invariably show the spread of contrast or dye extending to the paravertebral space that spread may be limited in degree. Thus follows a point of significant controversy as to whether the paravertebral space is in fact the block's primary site of action or whether it acts primarily on nerves, radicular and sympathetic, situated in the thoracolumbar fascia. Questions of mechanism and site of action notwithstanding, the safety and clinical efficacy of this block has been clearly demonstrated in multiple types of surgeries including abdominal laparoscopic , open laparotomy , urologic , and general surgery with analgesia lasting roughly 24 hours, decreased consumption of opioids, decreased time to ambulation, and decreased hospital length of stay. In recent studies, QL block employment was shown to produce a significant reduction in length of stay during hip surgery as well as similar analgesia to Lumbar Plexus blockade.

The quadratus lumborum block has since 2016 become standard of care for abdominal and hip surgeries at our institution, replacing paravertebral and lumbar plexus blocks respectively, and as part of a broader multimodal analgesia institutional ERAS (Enhanced Recovery After Surgery) protocol. Coincident with its implementation we have seen significant reductions in opiate and PCA use as well as hospital length of stay. Similar results have been reported by other institutions.

Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. There remain many unanswered questions regarding this block and its subtypes. It is, for example, unknown if one technique would be better than another for different types of surgery. Likewise little is known of the relative importance of local anesthetic concentration and injectate volume - the principal question addressed by this proposed study.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Shadyside Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients 18-80 years old Patients undergoing total hip arthroplasty BMI 19-45, >50 kg Male and Female All races American Society of Anesthesiologists physical status classification I, II, III Spinal Anesthesia Provided

Exclusion Criteria:

Pregnancy Non english speaking or inability to participate in the study Patients with coagulopathy or With INR >1.5 the day of the surgery. pharmacologic coagulopathy: patients on xarelto, plavix, or any kind of "Blood Thinners" Chronic steroid use: patients with consumption of steroid for more than 3 months.

Chronic pain: pain for more than 3 months Chronic opiate use : consumption of opioids for more than 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low Volume group; 30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each subject received 20mL Bupivacaine 0.375%.	Drug: Drug: Bupivacaine 0.375% diluted to 0.1875%; Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL); Other Names: High Volume
Experimental: High Volume group; 30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each subject was given 20mL Bupivacaine 0.375% diluted with 20mL normal saline to total 40mL (concentration decreased by half - 0.1875%).	Drug: Drug: Bupivacaine 0.375% 20 mL; 20 mL 0.375% Bupivacaine; Other Names: Low Volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Consumption of Opioids During the First 24 Hours After Surgery.	Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent	24 hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest	pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)	3-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest	pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)	6-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest	pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)	12-hours
Pain Measurement Through VAS (Visual Analogue Score) at Rest	pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)	24-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to 100ft Ambulation After Surgery	Time to ambulation after surgery (ability to walk 100 feet).	Post-operative 12-32 hours
Time to Consumption of the First Opioid After Surgery.	Time to consumption of the first opioid after surgery.	24 hours
Time to Hospital Discharge	Time to hospital discharge following surgery, measured in minutes	Post-operative day 1 to post-operative day 5

Collaborators and Investigators

• Sponsor: Anna Uskova
• Investigators: Principal Investigator: Anna Uskova, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: arthroplasty; Hip; Anesthesia,conduction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: STUDY19090192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data

Drug and device information, study documents

• 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.: No