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Quadratus Lumborum Block for Total Hip Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Active Comparator
Placebo Comparator
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring quadratus lumborum nerve block, analgesia, total hip arthroplasty, postoperative outcomes

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients undergoing elective primary total hip arthroplasty for osteoarthritis by a single surgeon.

Exclusion Criteria:

  • patients age < 18,
  • documented allergy to local anesthetic,
  • presence of peripheral neuropathy,
  • patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period, and
  • patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.
  • Additionally, patients who receive general anesthesia during the surgery, either as part of the planned anesthetic (at the discretion of the patient's assigned anesthesiologist) or as a rescue anesthetic after a failed spinal, will be excluded from the study. More specifically, if a patient is found to be moving their lower extremities or showing signs of sensation in the lower extremities 15 minutes after the spinal procedure is performed, this would be considered a failed spinal. In the case of a failed spinal, general anesthesia would be required to continue with surgery. After detection of a failed spinal, the anesthesiologist would make a determination about the safety of proceeding with general anesthesia versus aborting the surgery. If safe and consented for, or if emergent general anesthesia is required, the patient would be induced (given medications to begin) general anesthesia in a manner appropriate for the individual patient, taking into account their body habitus and medical history. Any patient who undergoes general anesthesia, including those for whom it is used as a rescue anesthetic as described, will be excluded from the study.

Sites / Locations

  • UCLA Medical Center, Santa MonicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

Quadratus lumborum nerve block with 0.25% ropivacaine

Quadratus lumborum nerve block with saline

Outcomes

Primary Outcome Measures

Pain score
Pain scores will be assessed over 48hrs postop using the visual analog score

Secondary Outcome Measures

Opioid usage
Total morphine-equivalent will be calculated at 0-24hrs and 24-48hrs postop.
Time to first stand
The period between the end of surgery and the patient's first successful attempt at standing, with or without the assistance of devices (i.e. walker, cane) or staff assistance.
Time to first ambulation
Time to first ambulation of 50 feet or more, with or without the help of assist devices (i.e. walker, cane) or staff assistance.
Ambulation distance
This data point will be measured in feet and will be determined by the distance ambulated during the patient's first ambulation attempt after surgery, regardless of the length of ambulation (This distance will be counted regardless of whether the patient reaches the 50 feet requirement to be counted as the "time to first ambulation).
Length of hospital stay
Number of days in the hospital from postoperative day 0 to discharge
Patient satisfaction
Patient satisfaction score will be assessed on day of discharge as measured by a 5-point scale with 1 = terrible, 2 = poor, 3 = satisfactory, 4 = good, and 5 = excellent.

Full Information

First Posted
January 30, 2022
Last Updated
December 5, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05247255
Brief Title
Quadratus Lumborum Block for Total Hip Arthroplasty
Official Title
Quadratus Lumborum (QL) Nerve Block for Patients Undergoing Primary Total Hip Arthroplasty (THA)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The quadratus lumborum (QL) block is a fascial plane block that has been described to provide analgesia from T7-L3 dermatomes. The investigators aim to evaluate the efficacy of QL blocks in patients undergoing primary total hip arthroplasty (THA).
Detailed Description
Investigators will enroll subjects planned for primary THA and allocate them into receiving a QL block with either saline or ropivacaine. Primary outcome will be pain scores over the first 48 hours after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
quadratus lumborum nerve block, analgesia, total hip arthroplasty, postoperative outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Quadratus lumborum nerve block with 0.25% ropivacaine
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Quadratus lumborum nerve block with saline
Intervention Type
Drug
Intervention Name(s)
Active Comparator
Intervention Description
QL block with 0.25% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
QL block with saline
Primary Outcome Measure Information:
Title
Pain score
Description
Pain scores will be assessed over 48hrs postop using the visual analog score
Time Frame
Up to 48 hrs post op
Secondary Outcome Measure Information:
Title
Opioid usage
Description
Total morphine-equivalent will be calculated at 0-24hrs and 24-48hrs postop.
Time Frame
Up to 48 hrs post op
Title
Time to first stand
Description
The period between the end of surgery and the patient's first successful attempt at standing, with or without the assistance of devices (i.e. walker, cane) or staff assistance.
Time Frame
Up to 1 week post surgery
Title
Time to first ambulation
Description
Time to first ambulation of 50 feet or more, with or without the help of assist devices (i.e. walker, cane) or staff assistance.
Time Frame
Up to 1 week post surgery
Title
Ambulation distance
Description
This data point will be measured in feet and will be determined by the distance ambulated during the patient's first ambulation attempt after surgery, regardless of the length of ambulation (This distance will be counted regardless of whether the patient reaches the 50 feet requirement to be counted as the "time to first ambulation).
Time Frame
Up to 1 week post surgery
Title
Length of hospital stay
Description
Number of days in the hospital from postoperative day 0 to discharge
Time Frame
Until discharge from hospital, up to 1 week post surgery
Title
Patient satisfaction
Description
Patient satisfaction score will be assessed on day of discharge as measured by a 5-point scale with 1 = terrible, 2 = poor, 3 = satisfactory, 4 = good, and 5 = excellent.
Time Frame
Until day of discharge from the hospital, up to 1 week post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects undergoing elective primary total hip arthroplasty Exclusion Criteria: patients age < 18, documented allergy to local anesthetic presence of peripheral neuropathy patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Scovotti, MA
Phone
310-206-4484
Email
jscovotti@mednet.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Bean, MD
Phone
310-267-8653
Email
hbean@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Chia, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center, Santa Monica
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Chia, MD
Phone
310-267-3217
Email
pchia@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Heidi Bean, MD
Phone
310-267-8653
Email
hbean@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Pamela Chia, MD
First Name & Middle Initial & Last Name & Degree
Alexandra Stavrakis, MD
First Name & Middle Initial & Last Name & Degree
Heidi Bean, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Quadratus Lumborum Block for Total Hip Arthroplasty

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