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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.

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Drug: Bupivacaine 0.375% 20 mL
Drug: Bupivacaine 0.375%
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Hip, Anesthesia,conduction, arthroplasty

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of pittsburgh
  • UPMC shadyside hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Low Volume group

High Volume group

Arm Description

30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml

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

Outcomes

Primary Outcome Measures

consumption of opioids during the first 24 hours after surgery.
Opioids administered to the patient in 24 hours

Secondary Outcome Measures

Pain measurement through VAS (Visual Analogue Score) at rest and with movement
pain scores at rest and in movement at 3, 6, 12, and 24 hours after surgery (minimum 1- maximum 10)
Patient satisfaction 24 hours after surgery.
Patient satisfaction survey
Consumption of non narcotic medication
Consumption of non narcotic medication during the first 24 hours
Time to ambulation after surgery
Time to ambulation after surgery (ability to walk 100 feet).
Presence of any adverse effect related to analgesic technique
Presence of any adverse effect related to analgesic technique
Time to consumption of the first opioid after surgery.
Time to consumption of the first opioid after surgery.

Full Information

First Posted
February 4, 2020
Last Updated
February 6, 2023
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04259645
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
January 30, 2023 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Hip, Anesthesia,conduction, arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Volume group
Arm Type
Active Comparator
Arm Description
30 subjects randomized to Low Volume will receive unilateral Quadratus Lumborum block type II. Each block of 0.375% Bupivacaine x 20 ml
Arm Title
High Volume group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Drug: Bupivacaine 0.375% 20 mL
Intervention Description
Each block of 0.375% Bupivacaine x 20 mL
Intervention Type
Drug
Intervention Name(s)
Drug: Bupivacaine 0.375%
Intervention Description
Each block of 0.375% Bupivacaine x 20 ml + Normal Saline Solution 20 mL
Primary Outcome Measure Information:
Title
consumption of opioids during the first 24 hours after surgery.
Description
Opioids administered to the patient in 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain measurement through VAS (Visual Analogue Score) at rest and with movement
Description
pain scores at rest and in movement at 3, 6, 12, and 24 hours after surgery (minimum 1- maximum 10)
Time Frame
24 hours
Title
Patient satisfaction 24 hours after surgery.
Description
Patient satisfaction survey
Time Frame
24 hours
Title
Consumption of non narcotic medication
Description
Consumption of non narcotic medication during the first 24 hours
Time Frame
24 hours
Title
Time to ambulation after surgery
Description
Time to ambulation after surgery (ability to walk 100 feet).
Time Frame
24 hours
Title
Presence of any adverse effect related to analgesic technique
Description
Presence of any adverse effect related to analgesic technique
Time Frame
24 hours
Title
Time to consumption of the first opioid after surgery.
Description
Time to consumption of the first opioid after surgery.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Uskova, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC shadyside hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data

Learn more about this trial

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.

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