NCT04574154CompletedNot Applicable
Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
Papa Giovanni XXIII Hospital2 sites in 1 country64 target enrollmentStarted: January 20, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- morphine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
morphine
Time Frame: 24 hours
milligrams of morphine consumed in the first postoperative day
Secondary Outcomes
- perceived postoperative pain: Numeric Rating Scale (NRS)(48 hours)
- side effects(48 hours)
Investigators
Dario Bugada
MD PhD, principal investigator, attending anesthesiologist
Papa Giovanni XXIII Hospital
Study Sites (2)
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