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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quadratus Lumborum Block for Abdominoplasty

NCT02949778

Pain, Postoperative Abdominoplasty

COMPLETED PHASE4

Continuous Nerve Block Block vs Combination of Single Block Plus Intravenous Lidocaine for Postoperative Pain.

NCT04208516

Postoperative Pain

TERMINATED PHASE4

The Minimal Effective Volume (MEV90) of Ropivacaine 0.75% for Ultrasound-guided Transmuscular Quadratus Lumborum Block

NCT04196270

Percutaneous Nephrolithotomy

UNKNOWN PHASE4

Qudratus Lumborum Block for Postoperative Pain After Endoscopic Prostatectomy.

NCT03600129

Prostate Cancer

COMPLETED NA

Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

NCT04539730

Arthroplasty Complications Adductor Canal Block Peripheral Nerve Block +1 more

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Analgesia Postoperative Pain Block

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

low volume High concentration group

1.Low Volume: 30 subjects randomized to Low Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,75% ropivacaine x 15 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age \<70, max dose 20 mcg for age \>70) + dexamethasone 4 mg

Group Type EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

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.

high volume low concentration

2.High Volume: 30 subjects randomized to High Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,375% ropivacaine x 30 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age \<70, max dose 20 mcg for age \>70) + dexamethasone 4 mg

Group Type EXPERIMENTAL

Ropivacaine 0.5% Injectable Solution

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No