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Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block
suprainguinal fascia iliaca block
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent Exclusion Criteria: 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure

Sites / Locations

  • Wuhan Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)

Suprainguinal fascia iliaca block (SFI group)

Arm Description

The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the flank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration.

With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle.

Outcomes

Primary Outcome Measures

The cumulative opioid consumption

Secondary Outcome Measures

The pain scores determined by the numeric rating scale (NRS, 0-10)
Quadriceps strength
The time to first rescue analgesia
Postoperative hospital length of stay
The Time to Ambulation
Adverse events

Full Information

First Posted
August 13, 2023
Last Updated
September 2, 2023
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05998954
Brief Title
Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty
Official Title
Randomized Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
August 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

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 a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. Regional analgesia techniques are critical components of an optimal multimodal analgesia technique for THA, as they have been shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby hindering postoperative mobilization. Recently, our group has developed a novel transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study was postoperative sufentanil consumption within the initial 24-h postoperative period after THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength, the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and the time to hospital discharge.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)
Arm Type
Experimental
Arm Description
The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the flank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration.
Arm Title
Suprainguinal fascia iliaca block (SFI group)
Arm Type
Active Comparator
Arm Description
With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle.
Intervention Type
Procedure
Intervention Name(s)
transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block
Intervention Description
Fifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.
Intervention Type
Procedure
Intervention Name(s)
suprainguinal fascia iliaca block
Intervention Description
Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
Primary Outcome Measure Information:
Title
The cumulative opioid consumption
Time Frame
At 24 postoperative hours
Secondary Outcome Measure Information:
Title
The pain scores determined by the numeric rating scale (NRS, 0-10)
Time Frame
At 1, 6, 12, 24, and 48 hours after the surgery
Title
Quadriceps strength
Time Frame
At 1, 6, 12, 24, and 48 hours after the surgery
Title
The time to first rescue analgesia
Time Frame
Within postoperative 48 hours
Title
Postoperative hospital length of stay
Time Frame
Up to 6 weeks
Title
The Time to Ambulation
Time Frame
Postoperative 48 hours
Title
Adverse events
Time Frame
Postoperative 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a posterolateral approach 5. Informed consent Exclusion Criteria: 1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders or language barrier 3. Analgesics intake, history of substance abuse 4. Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe liver failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Wu
Phone
15871715431
Email
15871715431@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xi Wu
Organizational Affiliation
Wuhan Union Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Wu
Phone
15871715431
Email
15871715431@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31668470
Citation
Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available.
Results Reference
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Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty

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