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Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04574154
Acronym
PTA-ALR
Enrollment
64
Registered
2020-10-05
Start date
2020-01-20
Completion date
2021-08-21
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.

Interventions

PROCEDUREESPB

ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml

PROCEDUREFIB

FIB with ultrasound: Ropivacaine 0.5% 40 ml

PROCEDUREspinal anesthesia

bupivacaine 0,5% 2.2 ml

Sponsors

Papa Giovanni XXIII Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* primary THR * informed consent

Exclusion criteria

* allergies to study drugs * spinal anesthesia contraindicated * kidney failure * epilepsy, psychiatric disease, neurologic deficits * revision surgery * neuropathies in the lumbar area * no informed consent * pregnancy * alcohol/opioid abuse * emergency surgery/intensive care

Design outcomes

Primary

MeasureTime frameDescription
morphine24 hoursmilligrams of morphine consumed in the first postoperative day

Secondary

MeasureTime frameDescription
perceived postoperative pain: Numeric Rating Scale (NRS)24 hs11 point scale from 0 = no pain to 10 = worst imaginable pain
side effects48 hoursoccurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026