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

NCT04077398 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: STUDY19070444
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Postoperative Pain; Block

Outcome Measures

Primary Outcomes (1)

• pain control over the next 72 hours after surgery: Visual analogue scale

  Visual analogue scale (0-10) measurement

  72 hours

Secondary Outcomes (4)

• opioid consumption during the first 72 hours

  72 hours

• time of the first opioid consumption after surgery

  24 hours

• 100 feet walking

  48 hours

• presence or absence of muscular weakness after Quadratus lumborum type 2 block

  24 hours

Study Arms (2)

low volume High concentration group

EXPERIMENTAL

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

Drug: Ropivacaine 0.5% Injectable Solution

high volume low concentration

EXPERIMENTAL

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

Drug: Ropivacaine 0.5% Injectable Solution

Interventions

Ropivacaine 0.5% Injectable Solution 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; low volume High concentration group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-90 years old
• Patients undergoing nephrectomy
• Body Mass Index 19-36
• Male and Female
• All races
• American Society of Anesthesiologist scale I, II, III

You may not qualify if:

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

Sponsors & Collaborators

• Bruce Ben-David: lead

Study Sites (1)

UPMC shadyside hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.

  PMID: 26735154 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Bites and Stings

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 4, 2019
• Study Start: January 22, 2020
• Primary Completion: January 1, 2021
• Study Completion: August 1, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)