NCT05998954

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2023

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 22, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

August 13, 2023

Last Update Submit

November 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The cumulative opioid consumption

    At 24 postoperative hours

Secondary Outcomes (6)

  • The pain scores determined by the numeric rating scale (NRS, 0-10)

    At 1, 6, 12, 24, and 48 hours after the surgery

  • Quadriceps strength

    At 1, 6, 12, 24, and 48 hours after the surgery

  • The time to first rescue analgesia

    Within postoperative 48 hours

  • Postoperative hospital length of stay

    Up to 6 weeks

  • The Time to Ambulation

    Postoperative 48 hours

  • +1 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block

Suprainguinal fascia iliaca block (SFI group)

ACTIVE COMPARATOR

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.

Procedure: suprainguinal fascia iliaca block

Interventions

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.

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

Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.

Suprainguinal fascia iliaca block (SFI group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (1)

  • 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.

    PMID: 31668470BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Xi Wu

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 13, 2023

First Posted

August 21, 2023

Study Start

August 22, 2023

Primary Completion

August 20, 2024

Study Completion

October 20, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations