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 ConsumptionPrimary· 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
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
29.3
± 24.0
Group Will Receive Nerve Block Per Standard of Care
30.8
± 22.7
24 hours Post Op
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
49.6
± 36.8
Group Will Receive Nerve Block Per Standard of Care
51.8
± 37.5
48 Hours Post Op
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
62.1
± 47.7
Group Will Receive Nerve Block Per Standard of Care
67.7
± 52.4
72 Hours Post Op
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
68.6
± 58.5
Group Will Receive Nerve Block Per Standard of Care
71.4
± 55.9
Change in Pain Intensity While in HospitalSecondary· 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
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
4.9
± 2.4
Group Will Receive Nerve Block Per Standard of Care
5.0
± 2.1
Post Operation Day 1
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
4.2
± 2.1
Group Will Receive Nerve Block Per Standard of Care
4.4
± 2.0
Post Operation Day 2
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
3.9
± 2.3
Group Will Receive Nerve Block Per Standard of Care
4.0
± 1.9
Length of StaySecondary· 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.
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
47.2
± 24.8
Group Will Receive Nerve Block Per Standard of Care
46.7
± 25.9
Brief Pain Inventory: InterferenceSecondary· 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
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
6.2
± 2.5
Group Will Receive Nerve Block Per Standard of Care
6.3
± 2.2
2 Weeks Post Operation
Group
Value
95% CI
Group Will NOT Receive Any Nerve Blocks.
2.8
± 2.1
Group Will Receive Nerve Block Per Standard of Care
2.8
± 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.
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· EARLY_PHASE1
· withdrawn
Other recruiting trials for Hip Arthropathy
Currently open trials in the same condition.
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Trials by the same sponsor.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Yale University
Last refreshed: 23 September 2022
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.