NCT06688136

Brief Summary

Local and/or regional analgesia techniques are critical components of an optimal multimodal analgesia technique, as they have been shown to improve pain relief as well as reduce opioid requirements. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Periarticular infiltration (PAI) is increasingly included as a component of multimodal analgesia technique for patients undergoing THA, as it provides improved postoperative pain relief with no effects on quadriceps function. 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. Therefore, we designed a randomized controlled trial to compare ultrasound-guided QLESP with PAI as a component of non-opioid analgesic regimen in patients undergoing THA via posterior approach. We hypothesized that QLESP would provide superior analgesia when compared with PAI. The primary outcome of the study was postoperative opioid requirements 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

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

November 18, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
Last Updated

September 9, 2025

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 11, 2024

Last Update Submit

September 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The cumulative opioid consumption

    At 24 postoperative hours

Secondary Outcomes (3)

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

    Postoperative 48 hours

  • Quadriceps strength

    Postoperative 48 hours

  • Postoperative hospital length of stay

    Up to 6 weeks

Study Arms (2)

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

EXPERIMENTAL

Twenty ml of 0.4% ropivacaine was administered between the erector spinae muscle and the transverse process. Twenty ml of 0.4% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.

Drug: ropivacaine

Infiltration

ACTIVE COMPARATOR

Periarticular infiltration of 40 ml of 0.4% ropivacaine prior to closing the incision

Drug: ropivacaine

Interventions

Ropivacaine 200 mg diluted to 50 mL

Infiltrationtransmuscular quadratus lumborum and modified erector spinae plane (QLESP) block

Eligibility Criteria

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

You may qualify if:

  • Age 18-65 yrs
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35 (kg/m2)
  • Undergo elective primary unilateral THA via a posterolateral approach
  • Informed consent

You may not qualify if:

  • A known allergy to the drugs being used
  • Pre-existing neuropsychiatric disorders or language barrier
  • Analgesics intake, history of substance abuse
  • Contraindications to peripheral nerve block
  • Acute cerebrovascular disease
  • Severe liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Xi Wu

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Huazhong University of Science and Technology

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 14, 2024

Study Start

November 18, 2024

Primary Completion

September 5, 2025

Study Completion

September 5, 2025

Last Updated

September 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations