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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04259645
Enrollment
60
Registered
2020-02-06
Start date
2021-04-01
Completion date
2023-01-30
Last updated
2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

Hip, Anesthesia,conduction, arthroplasty

Brief summary

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.

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.

Interventions

DRUGDrug: Bupivacaine 0.375% 20 mL

20 mL 0.375% Bupivacaine

DRUGDrug: 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)

Sponsors

Anna Uskova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

An envelope will contain the randomized concentration and volume of ropivacaine to be administered to the patient. Once the anesthesiologist knows which volume he is going to administer, he will reseal the envelope and return it to the research team. This process will allow only the anesthesiologist performing the block to have knowledge of the volume he is administering, keeping both the patients and outcome assessor of the research team blinded. The anesthesiologist will fill the syringe with the appropriate volume of medication. Immediately after, he will cover the numbers on the syringe with a piece of opaque tape, preventing any others from visualizing the volume to be administered.

Intervention model description

The study will be conducted as a prospective, randomized, double blinded, parallel trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Consumption of Opioids During the First 24 Hours After Surgery.24 hoursOpioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent
Pain Measurement Through VAS (Visual Analogue Score) at Rest3-hourspain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)

Secondary

MeasureTime frameDescription
Time to 100ft Ambulation After SurgeryPost-operative 12-32 hoursTime to ambulation after surgery (ability to walk 100 feet).
Time to Consumption of the First Opioid After Surgery.24 hoursTime to consumption of the first opioid after surgery.
Time to Hospital DischargePost-operative day 1 to post-operative day 5Time to hospital discharge following surgery, measured in minutes

Countries

United States

Participant flow

Participants by arm

ArmCount
Low Volume Group
30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml Drug: Bupivacaine 0.375%: Each block of 0.375% Bupivacaine x 20 mL
29
High Volume Group
30 subjects randomized to High Volume will receive unilateral Quadratus lumborum block Type II. Each block of 0.375% Bupivacaine x 20 mL + Normal Saline Solution 20 mL Drug: Bupivacaine 0.375% 20 mL: Each block of 0.375% Bupivacaine x 20 mL diluted with 20mL of Normal Saline Solution
31
Total60

Baseline characteristics

CharacteristicLow Volume GroupHigh Volume GroupTotal
Age, Continuous63.7 years
STANDARD_DEVIATION 8.1
65.4 years
STANDARD_DEVIATION 8.7
64.55 years
STANDARD_DEVIATION 8.4
BMI31.0 kg/m2
STANDARD_DEVIATION 5.4
30.6 kg/m2
STANDARD_DEVIATION 5.7
30.8 kg/m2
STANDARD_DEVIATION 5.5
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
29 participants31 participants60 participants
Sex: Female, Male
Female
13 Participants15 Participants28 Participants
Sex: Female, Male
Male
16 Participants16 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 31
other
Total, other adverse events
0 / 290 / 31
serious
Total, serious adverse events
0 / 290 / 31

Outcome results

Primary

Consumption of Opioids During the First 24 Hours After Surgery.

Opioids administered to the patient in 24 hours, measured as averaged morphine milligram equivalent

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupConsumption of Opioids During the First 24 Hours After Surgery.46.2 mg morphine equivalents per 24 hoursStandard Deviation 25.9
High Volume GroupConsumption of Opioids During the First 24 Hours After Surgery.35.0 mg morphine equivalents per 24 hoursStandard Deviation 27.1
Primary

Pain Measurement Through VAS (Visual Analogue Score) at Rest

pain scores at rest at 3 hours after surgery (minimum 0 - maximum 10)

Time frame: 3-hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest4.52 score on a scaleStandard Deviation 2.76
High Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest4.48 score on a scaleStandard Deviation 2.81
Primary

Pain Measurement Through VAS (Visual Analogue Score) at Rest

pain scores at rest at 6 hours after surgery (minimum 0 - maximum 10)

Time frame: 6-hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest5.76 score on a scaleStandard Deviation 2.71
High Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest5.08 score on a scaleStandard Deviation 2.21
Primary

Pain Measurement Through VAS (Visual Analogue Score) at Rest

pain scores at rest at 12 hours after surgery (minimum 0 - maximum 10)

Time frame: 12-hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest5.52 score on a scaleStandard Deviation 2.23
High Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest5.59 score on a scaleStandard Deviation 2.83
Primary

Pain Measurement Through VAS (Visual Analogue Score) at Rest

pain scores at rest at 24 hours after surgery (minimum 0 - maximum 10)

Time frame: 24-hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest4.78 score on a scaleStandard Deviation 2.53
High Volume GroupPain Measurement Through VAS (Visual Analogue Score) at Rest5.50 score on a scaleStandard Deviation 2.75
Secondary

Time to 100ft Ambulation After Surgery

Time to ambulation after surgery (ability to walk 100 feet).

Time frame: Post-operative 12-32 hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupTime to 100ft Ambulation After Surgery1534 minutesStandard Deviation 1055
High Volume GroupTime to 100ft Ambulation After Surgery1178 minutesStandard Deviation 1219
Secondary

Time to Consumption of the First Opioid After Surgery.

Time to consumption of the first opioid after surgery.

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupTime to Consumption of the First Opioid After Surgery.120 minutesStandard Deviation 97
High Volume GroupTime to Consumption of the First Opioid After Surgery.165 minutesStandard Deviation 270
Secondary

Time to Hospital Discharge

Time to hospital discharge following surgery, measured in minutes

Time frame: Post-operative day 1 to post-operative day 5

ArmMeasureValue (MEAN)Dispersion
Low Volume GroupTime to Hospital Discharge1865 minutesStandard Deviation 1480
High Volume GroupTime to Hospital Discharge1560 minutesStandard Deviation 1491

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026