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QL vs PENG for Analgesia After Hip Arthroplasty

Primary Purpose

Block, Hip Replacement, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PENG + LFC Block
QL Block
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Block

Eligibility Criteria

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

Inclusion Criteria: age greater than or equal to 18 years of age undergoing elective hip arthroplasty with planned same day discharge Exclusion Criteria: local anesthetic allergy subjects with a weight less than 40kg subjects that are unable or choose not to give informed consent Known preoperative substance abuse

Sites / Locations

  • MUSCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PENG + LFC Block

QL Block

Arm Description

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule [5,6]. In the PENG block, a low-frequency, curvilinear probe is used to visualize the anterior inferior iliac spine, iliopsoas tendon, and iliopubic eminence. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. The needle is advanced until the tip lies on the lateral and inferior margin of the iliopsoas tendon between the anterior inferior iliac spine (lateral) and iliopubic eminence (deep).

The lateral QL block is performed by injecting local anesthetic deep to the transversus abdominis aponeurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.

Outcomes

Primary Outcome Measures

Postoperative cumulative opioid consumption
The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, up to 72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.

Secondary Outcome Measures

Postoperative pain score measures
Postoperative pain score measures on the visual analog scale (VAS) from 0-100 captured in the preoperative area, PACU, and through 72-hours post-op. The lower the reported pain score, the better the outcome.

Full Information

First Posted
January 12, 2023
Last Updated
March 1, 2023
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT05710107
Brief Title
QL vs PENG for Analgesia After Hip Arthroplasty
Official Title
The Impact or Quadratum Lumborum (QL) Block Versus Pericapsular Nerve Group (PENG) With Lateral Femoral Cutaneous (LFC) Nerve Blocks for Analgesia After Hip Arthroplasty: a Prospective, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

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

5. Study Description

Brief Summary
This study will consist of patients 18 years and older who are undergoing elective hip replacement with planned same day discharge. The patients will be randomized to receive a PENG+LFC or QL block prior to undergoing the surgery to help with postoperative pain control. The primary goal will be assessing postoperative opioid use during the first 72 hours after surgery. Secondary outcomes will include postoperative pain scores from, 0-72 hours. Additional outcomes consist of time to first ambulation, functional and mobility outcomes, PACU duration, patient satisfaction and opioid related side effects.
Detailed Description
Patients demographic data and health information will be collected including age, height, weight, and details related to injury from the medical record. Patients will also be asked to complete a set of questionnaires detailing how they feel prior to the procedure. Patients will be randomly assigned to one of two groups. Group A will receive the PENG + LFC block. Group B will receive the QL block. Patients will be sedated while receiving either block. If patients are assigned to the QL block, ultrasound technology will be used to identify appropriate structures on the side of the abdomen. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A second needle will be inserted into the side of the abdomen and a numbing medication called ropivacaine will be injected.\ If patients are randomized to receive PENG + LFC, ultrasound technology will be used to identify appropriate structures between the hip and groin area. An injection of lidocaine (numbing medication) into the skin will be inserted first for comfort. A needle will be inserted to the appropriate location between the hip and groin, and a numbing medication called ropivacaine will be injected. This may take more than one injection in the same area. Surgery will begin shortly after the placement of the nerve block(s). Before being discharged from the surgery center, patients will be asked their current pain score (0-100) and the study team will provide a detailed information sheet that includes instructions for the study follow-up period. Patients will receive a text message with a link to a questionnaire at 9:00 AM, and 3:00 PM for the first three days after surgery. This questionnaire will ask them to rate their average pain at rest and while moving in a specific time period by using a visual scale from 0-100. The study will also ask questions about the pain medication taken in that same time period. At day 7, participants will receive a survey link via text message with additional questions about recovery. If they do not wish to be contacted by text message, someone from the study team will contact them by telephone at the end of the seven days and ask them to read back the information recorded on the paper data sheet provided. At approximately 2-3 weeks after surgery, and again at approximately 6 weeks after surgery a study team member will contact patients either via telephone or visit patients during their post-surgical clinic visit to complete a set of questionnaires related to their recovery. Patients will also be asked to report any side effects, urgent care/emergency room visits, or any new conditions while participating in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Block, Hip Replacement, Postoperative Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Subjects, surgeons, and data collectors will all be blinded to the allocated group. Unblinded personnel will be the Anesthesia Attending placing the block and clinical staff assisting.
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG + LFC Block
Arm Type
Active Comparator
Arm Description
The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule [5,6]. In the PENG block, a low-frequency, curvilinear probe is used to visualize the anterior inferior iliac spine, iliopsoas tendon, and iliopubic eminence. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. The needle is advanced until the tip lies on the lateral and inferior margin of the iliopsoas tendon between the anterior inferior iliac spine (lateral) and iliopubic eminence (deep).
Arm Title
QL Block
Arm Type
Active Comparator
Arm Description
The lateral QL block is performed by injecting local anesthetic deep to the transversus abdominis aponeurosis and superficial to the fascia transversalis with direct ultrasound guidance. After completing consent, placing monitors and providing mild sedation, the patient is positioned laterally and the muscular anatomy (external oblique, internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles) identified. After placing a subcutaneous skin wheel with lidocaine, a blunt regional anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is deposited incrementally with frequent aspiration in the anterolateral border of the quadratus lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of the thoracolumbar fascia and superficial to the fascia transversalis.
Intervention Type
Other
Intervention Name(s)
PENG + LFC Block
Intervention Description
Subjects assigned to this group will receive PENG + LFC Block
Intervention Type
Other
Intervention Name(s)
QL Block
Intervention Description
Subjects randomized to this group will receive a QL Block
Primary Outcome Measure Information:
Title
Postoperative cumulative opioid consumption
Description
The primary outcome will be postoperative cumulative opioid consumption (in IV morphine mg equivalents: IV MME) over time, up to 72 hours postoperatively. Cumulative opioid consumption will be evaluated at PACU, and through 72 hours post-op.
Time Frame
0-72 hours postoperatively
Secondary Outcome Measure Information:
Title
Postoperative pain score measures
Description
Postoperative pain score measures on the visual analog scale (VAS) from 0-100 captured in the preoperative area, PACU, and through 72-hours post-op. The lower the reported pain score, the better the outcome.
Time Frame
0-72 hours postoperatively
Other Pre-specified Outcome Measures:
Title
Time to First Ambulation
Description
How many minutes after anesthesia stop time patients first ambulate
Time Frame
From anesthesia stop time to first ambulation in minutes, assessed up to 7 days post-op.
Title
Physical, mental, and social aspects of health
Description
The PROMIS Global Health Questionnaire will assess functional outcomes such by evaluating the patient's physical, mental, and social aspects of health.
Time Frame
Up to 6 weeks post-operatively
Title
Overall hip health
Description
The HOOS Jr will assess overall Hip Health in participants.
Time Frame
Up to 6 weeks post-operatively
Title
Patient Satisfaction
Description
We will be evaluating the patient's satisfaction with their post-op recovery by administering a satisfaction assessment.
Time Frame
0-72 hours postoperatively
Title
PACU Duration
Description
Time patient spent in PACU
Time Frame
surgery end to time discharged from PACU, assessed up to 6 weeks post-op
Title
Number of opioid related side-effects
Description
Side effects experienced from opioids
Time Frame
0-72 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age greater than or equal to 18 years of age undergoing elective hip arthroplasty with planned same day discharge Exclusion Criteria: local anesthetic allergy subjects with a weight less than 40kg subjects that are unable or choose not to give informed consent Known preoperative substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haley Nitchie, MHA
Phone
843-792-1869
Email
nitchie@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Hay, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Nitchie, MHA
Phone
843-792-1869
Email
nitchie@musc.edu
First Name & Middle Initial & Last Name & Degree
Ellen Hay, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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QL vs PENG for Analgesia After Hip Arthroplasty

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