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Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty

Primary Purpose

Osteoarthritis, Total Hip Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LPB
QLB
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Lumbar Plexus Block, Quadratus Lumborum Block, Direct Anterior Approach, Post-Operative, Pain Management

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Any patient between the ages of 18 and 95 years undergoing a primary elective, unilateral DAA total hip arthroplasty.

Exclusion Criteria:

  • If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations.
  • Indication for surgery is secondary to trauma and/or hip fracture
  • If there is a contraindication to the performance of a regional block
  • Concomitant anticoagulation use or documented coagulopathy
  • Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade
  • Presence of progressive neurologic deficit effecting peripheral nerves
  • Allergy or adverse reaction to study drugs to include: fentanyl, epinephrine, and amide local anesthetics
  • American Society of Anesthesia Physical Classification score > or = to 4
  • Allergies to study drugs other than local anesthetic
  • BMI > 40
  • Patient refusal
  • Pregnancy
  • Institutionalized individuals
  • Extremes of age: Age > 95 or < 18
  • Non English speaking or inability to reliably participate in the study

Sites / Locations

  • Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LPB Unilateral DAA THA

QLB Unilateral DAA THA

Arm Description

Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.

Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.

Outcomes

Primary Outcome Measures

Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.

Secondary Outcome Measures

Time to first analgesic
Time from PACU discharge to first requested analgesic
Total opioid consumption over 24 hours
Total opioid consumption in the first 24hrs
Verbal numeric pain score at 6hrs at rest (NRS)
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.
Verbal numeric pain score at rest and with movement at 24hrs post block
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.
Ability to straight leg raise on POD1
Is the patient able to perform an unassisted straight leg raise
Rates of opioid related side effects (nausea, vomiting, pruritis)
Has the patient had any nausea, vomiting, or pruritis within the first 24hrs
Patient satisfaction utilizing a Likert-scale questionnaire
A patient satisfaction survey to administered on post operative day 1

Full Information

First Posted
January 18, 2018
Last Updated
May 8, 2020
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03409900
Brief Title
Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty
Official Title
Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty: A Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with end stage osteoarthritis. In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA). The literature supports that DAA is superior to PLA with regard to lower blood loss, less pain, shorter hospital stay, and faster rehabilitation. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. This study is designed to compare the efficacy, with regards to post-operative pain management, between LPB and QLB following a DAA total hip arthroplasty.
Detailed Description
In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA) in regards to total hip arthroplasty (THA). The DAA technique involves dissection of muscular planes for insertion of components resulting in less tissue damage as compared to PLA. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. This technique works well for the traditionally performed PLA in that the hip joint and incision site are within the analgesic distribution of the LPB. Conversely, the DAA utilizes an anterior incision that overlies the L1 and L2 dermatomes as opposed to the lower lumbar dermatomes of the PLA incision. When performing LPB it has been the study team's clinical experience that it is rare to achieve analgesia in the proximal distribution of the lumbar plexus resulting in apparent sparing of the L1 and L2 nerve root distributions. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. The QLB is thought to provide analgesia by blocking both the lateral and anterior cutaneous branches of T7 through L4. This degree of dermatomal coverage suggests that QLB could be an efficacious alternative to LPB for DAA hip arthroplasty. It is hypothesized that the QLB will provide equivalent analgesia when compared to the LPB as determined by a comparison of verbal reported pain scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Total Hip Arthroplasty
Keywords
Lumbar Plexus Block, Quadratus Lumborum Block, Direct Anterior Approach, Post-Operative, Pain Management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LPB Unilateral DAA THA
Arm Type
Experimental
Arm Description
Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.
Arm Title
QLB Unilateral DAA THA
Arm Type
Experimental
Arm Description
Patients will be randomized to receive either a LPB or QLB for post-operative analgesia. Randomization to either LPB or QLB will occur via block randomization using sealed sequentially numbered opaque envelopes that will correspond to the order with which patients are enrolled. Patients and research assistants will be blinded to their randomization by administration of intravenous sedation (titrated to patient comfort), utilization of ultrasonography to visualize pertinent structures for both blocks, and by the nature of the block technique themselves both being in close proximity on the posterior lower back.
Intervention Type
Other
Intervention Name(s)
LPB
Other Intervention Name(s)
Lumbar Plexus Block
Intervention Description
The LPB will be performed in a lateral position, but modified to utilize ultrasound guidance to enhance our ability to quickly and safely locate the lumbar plexus as well as to avoid unblinding with regard to the traditional landmark LPB technique. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
Intervention Type
Other
Intervention Name(s)
QLB
Other Intervention Name(s)
Quadratus Lumborum Block
Intervention Description
The QLB will be performed in a lateral position in a manner consistent with the technique first described by Børglum. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
Primary Outcome Measure Information:
Title
Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))
Description
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.
Time Frame
6 hours post block
Secondary Outcome Measure Information:
Title
Time to first analgesic
Description
Time from PACU discharge to first requested analgesic
Time Frame
During hospitalization, up to 24hrs
Title
Total opioid consumption over 24 hours
Description
Total opioid consumption in the first 24hrs
Time Frame
24 hrs post block
Title
Verbal numeric pain score at 6hrs at rest (NRS)
Description
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.
Time Frame
6hrs post block
Title
Verbal numeric pain score at rest and with movement at 24hrs post block
Description
Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.
Time Frame
24hrs post block
Title
Ability to straight leg raise on POD1
Description
Is the patient able to perform an unassisted straight leg raise
Time Frame
Post operative day 1
Title
Rates of opioid related side effects (nausea, vomiting, pruritis)
Description
Has the patient had any nausea, vomiting, or pruritis within the first 24hrs
Time Frame
Within 24hrs post block
Title
Patient satisfaction utilizing a Likert-scale questionnaire
Description
A patient satisfaction survey to administered on post operative day 1
Time Frame
Post operative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient between the ages of 18 and 95 years undergoing a primary elective, unilateral DAA total hip arthroplasty. Exclusion Criteria: If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations. Indication for surgery is secondary to trauma and/or hip fracture If there is a contraindication to the performance of a regional block Concomitant anticoagulation use or documented coagulopathy Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade Presence of progressive neurologic deficit effecting peripheral nerves Allergy or adverse reaction to study drugs to include: fentanyl, epinephrine, and amide local anesthetics American Society of Anesthesia Physical Classification score > or = to 4 Allergies to study drugs other than local anesthetic BMI > 40 Patient refusal Pregnancy Institutionalized individuals Extremes of age: Age > 95 or < 18 Non English speaking or inability to reliably participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Edwards, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty

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