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Volume vs Concentration: Quadratus Lumborum Blocks With High Volume/Low Concentration or Low Volume/ High Concentration in Nephrectomies

Volume Versus Concentration: a Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Bilateral Quadratus Lumborum Blocks Using High Volume/Low Concentration or Low Volume/ High Concentration Local Anesthetic in Nephrectomies

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04077398
Enrollment
0
Registered
2019-09-04
Start date
2020-01-22
Completion date
2021-08-01
Last updated
2021-02-16

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

Conditions

Analgesia, Block, Postoperative Pain

Brief summary

The quadratus lumborum has since 2016 become standard of care for abdominal and retroperitoneal surgeries at UPMC-Shadyside Hospital, replacing paravertebral blocks, and as part of a broader multimodal analgesia institutional Enhanced Recovery After surgery protocol. 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. What is proposed here is to investigate the relative clinical effectiveness of the relationship high volume/low concentration of local anesthetic or low volume/ high concentration of local anesthetic.

Interventions

DRUGRopivacaine 0.5% Injectable Solution

There will be two groups, in order to compare two different sets of volumes with the same amount of drug. we will try to identify if it is better one volume over the other in terms of pain control and consume of opioids, as well the presence or absence of motor weakness.

Sponsors

Bruce Ben-David
Lead SponsorOTHER

Study design

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

Masking description

Randomization will be performed with software excel or spss. This randomization will be kept in an envelope. After the patient consents participation in the study, the investigator and the care provider will open the envelope and will perform the block according to the established in the randomization. The patient or the outcomes assessor will not have access to the volume and concentration used during the block. Will be the responsibility of investigators to keep in a safe place the information about the block received by the patients.

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

1. Patients 18-90 years old 2. Patients undergoing nephrectomy 3. Body Mass Index 19-36 4. Male and Female 5. All races 6. American Society of Anesthesiologist scale I, II, III

Exclusion criteria

1. Patient refusal 2. Pregnancy 3. Non-English speaking or inability to participate in the study 4. Patients with coagulopathy or With International Normalized Ratio \>1,5 the day of the surgery. 5. Chronic steroid use 6. Chronic pain 7. Chronic opiate use

Design outcomes

Primary

MeasureTime frameDescription
pain control over the next 72 hours after surgery: Visual analogue scale72 hoursVisual analogue scale (0-10) measurement

Secondary

MeasureTime frameDescription
opioid consumption during the first 72 hours72 hoursopioid consumption in morphine milliequivalents during the first 72 hours
time of the first opioid consumption after surgery24 hourstime after surgery that patient takes to require opioid medication after surgery
100 feet walking48 hourstime after surgery that the patient takes in order to be able to walk 100 feet
presence or absence of muscular weakness after Quadratus lumborum type 2 block24 hoursmuscular weakness is associated sometime with femoral quadratus muscle weakness

Countries

United States

Outcome results

None listed

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