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Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty

Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03860324
Acronym
ESFIBHA
Enrollment
0
Registered
2019-03-01
Start date
2019-04-01
Completion date
2019-12-31
Last updated
2021-08-27

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

Conditions

Pain, Postoperative

Keywords

Hip Arthroplasty, Erector Spinae Plane Block

Brief summary

The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves. Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks. The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).

Interventions

PROCEDURESingle-shot erector spinae plane block

Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.

PROCEDURESingle-shot fascia iliaca block

Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%

Sponsors

Hospital Beatriz Ângelo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Surgical plan for total hip replacement * Signing of consent form to participate in the study

Exclusion criteria

* Patient refusal * BMI \> 40 kg/m2 * Surgical plan for revision of hip replacement * Patient unable to quantify pain level * Chronic kidney disease with a Glomerular Filtration Rate \< 50ml/min * Previously medicated with opioids * Patient unable to perform the surgery with spinal block * Allergy to local anesthetics * Infection in the site of the Erector Spinae Plane or Fascia Iliaca block * Allergy or contraindication to the use of morphine

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain level measured by the Visual Analog ScaleAt 6 hours post-operativeMeasurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesiaAt 24 hours post-operativeTotal amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes

Secondary

MeasureTime frameDescription
Sensory block assessed through a temperature testAt 24 hours post-operativeAssessment of sensory block through a temperature test and comparison with the contralateral limb (sensory block vs no sensory block)
Muscle Strength gradeAt 12 hours post-operativeMuscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle Muscle strength scale: Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance
Sensory block assessed through a tactile stimulation testAt 24 hours post-operativeAssessment of sensory block through a tactile stimulation test and comparison with the contralateral limb (sensory block vs no sensory block)
Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patientAt 24 hours post-operativePresence of side effects (pruritus, urinary retention, nausea/vomiting)

Countries

Portugal

Outcome results

None listed

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