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Completed

NCT Number: NCT04574154

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aast Papa Giovanni Xxiii

Bergamo, 24127, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FIB

Procedure

FIB with ultrasound: Ropivacaine 0.5% 40 ml

ESPB

Procedure

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

Spinal anesthesia

Procedure

bupivacaine 0,5% 2.2 ml

Primary outcomes

  1. morphine

    Time frame: 24 hours

    milligrams of morphine consumed in the first postoperative day

Secondary outcomes

  1. perceived postoperative pain: Numeric Rating Scale (NRS)

    Time frame: 24 hs

    11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

  2. perceived postoperative pain: Numeric Rating Scale (NRS)

    Time frame: 48 hours

    11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"

  3. side effects

    Time frame: 48 hours

    occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

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

Acronym: PTA-ALR

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Dec 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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