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.

NCT04259645 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY19090192
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Pain

Keywords

Hip; Anesthesia,conduction; arthroplasty

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Time to 100ft Ambulation After Surgery

  Post-operative 12-32 hours

• Time to Consumption of the First Opioid After Surgery.

  24 hours

• Time to Hospital Discharge

  Post-operative day 1 to post-operative day 5

Study Arms (2)

Low Volume group

ACTIVE COMPARATOR

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%

High Volume group

EXPERIMENTAL

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

Interventions

Drug: Bupivacaine 0.375% 20 mL DRUG

20 mL 0.375% Bupivacaine

Also known as: Low Volume

High Volume group

Drug: Bupivacaine 0.375% diluted to 0.1875% DRUG

Each block of 0.375% Bupivacaine x 20 ml mixed (diluted) with Normal Saline Solution 20 mL (total 40 mL)

Also known as: High Volume

Low Volume 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 18-80 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anna Uskova: lead

Study Sites (2)

University of pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC shadyside hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Bupivacaine; Hospitals, Low-Volume; Hospitals, High-Volume

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hospitals; Health Facilities; Health Care Facilities Workforce and Services

Limitations and Caveats

This was a single hospital trial, and external validity may be attenuated. THA is a relatively standardized procedure with similar patient care in the operating room, PACU, and floor ward. With only 60 patients total, this study is underpowered, and the wide standard deviations suggest a need for a much larger study. Pain score reported as the worst score over the previous 3 hours (interval) and reflects pain at rest post PT activity as day progresses, what may decrease the accuracy of report.

Results Point of Contact

• Title: Anna Uskova, MD
• Organization: UPMC Department of Anesthesiology and Perioperative Medicine

uskoaa@upmc.edu

412-623-2167

Study Officials

• Anna Uskova, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate 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: February 4, 2020
• First Posted: February 6, 2020
• Study Start: April 1, 2021
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: July 10, 2024
• Results First Posted: July 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)