Last reviewed · How we verify

NCT03977454

Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty

Completed Phase 2 Results posted Last updated 23 September 2022
What this trial tests

Phase 2 trial testing Nerve Block in Hip Arthropathy in 192 participants. Completed in 19 June 2021.

Timeline
11 November 2019
Primary endpoint
19 June 2021
19 June 2021

Quick facts

Lead sponsorYale University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment192
Start date11 November 2019
Primary completion19 June 2021
Estimated completion19 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with Hip Arthropathy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Daily Opioid Consumption Primary · Up to 72 hours

Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.

12 hours Post Op
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.29.3± 24.0
Group Will Receive Nerve Block Per Standard of Care30.8± 22.7
24 hours Post Op
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.49.6± 36.8
Group Will Receive Nerve Block Per Standard of Care51.8± 37.5
48 Hours Post Op
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.62.1± 47.7
Group Will Receive Nerve Block Per Standard of Care67.7± 52.4
72 Hours Post Op
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.68.6± 58.5
Group Will Receive Nerve Block Per Standard of Care71.4± 55.9
Change in Pain Intensity While in Hospital Secondary · Up to 2 days

Pain intensity will be assessed using a pain inventory modified from Brief Pain Inventory (BPI). The BPI has a range of 0-10 where: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Outcome measure was updated at the time of results entry.

Pre Operation
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.4.9± 2.4
Group Will Receive Nerve Block Per Standard of Care5.0± 2.1
Post Operation Day 1
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.4.2± 2.1
Group Will Receive Nerve Block Per Standard of Care4.4± 2.0
Post Operation Day 2
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.3.9± 2.3
Group Will Receive Nerve Block Per Standard of Care4.0± 1.9
Length of Stay Secondary · Up to 5 days

The patient's post surgical length of stay in the hospital will be compared between treatment groups. Length of stay is presented as average total hours in hospital.

GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.47.2± 24.8
Group Will Receive Nerve Block Per Standard of Care46.7± 25.9
Brief Pain Inventory: Interference Secondary · 2 weeks post operation

The Brief Pain Inventory: Interference (BPI:I) was used in place of the Harris Hip Score (HHS) to assess post operative conditions following hip surgery. The BPI:I uses a 10 point score where the normal range of scores is: 0 no interference - 10 complete interference.

Pre Operation
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.6.2± 2.5
Group Will Receive Nerve Block Per Standard of Care6.3± 2.2
2 Weeks Post Operation
GroupValue95% CI
Group Will NOT Receive Any Nerve Blocks.2.8± 2.1
Group Will Receive Nerve Block Per Standard of Care2.8± 2.1

Sponsor's own description

This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Nerve Block

Trials testing the same drug.

Other recruiting trials for Hip Arthropathy

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03977454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing