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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05247255
Other study ID # 21-001850
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date March 29, 2022
Est. completion date March 2025

Study information

Verified date December 2023
Source University of California, Los Angeles
Contact Jennifer Scovotti, MA
Phone 310-206-4484
Email jscovotti@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date March 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Active Comparator
QL block with 0.25% ropivacaine
Placebo Comparator
QL block with saline

Locations

Country Name City State
United States UCLA Medical Center, Santa Monica Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score Pain scores will be assessed over 48hrs postop using the visual analog score Up to 48 hrs post op
Secondary Opioid usage Total morphine-equivalent will be calculated at 0-24hrs and 24-48hrs postop. Up to 48 hrs post op
Secondary 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. Up to 1 week post surgery
Secondary 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. Up to 1 week post surgery
Secondary 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). Up to 1 week post surgery
Secondary Length of hospital stay Number of days in the hospital from postoperative day 0 to discharge Until discharge from hospital, up to 1 week post surgery
Secondary 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. Until day of discharge from the hospital, up to 1 week post surgery
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