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

November 28, 2021 updated by: Dario Bugada, Papa Giovanni XXIII Hospital

Regional Anesthesia in THR - Comparing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24127
        • Aast Papa Giovanni Xxiii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FIB
ultrasound guided Fascia Iliaca Block
Procedure: FIB
FIB with ultrasound: Ropivacaine 0.5% 40 ml
Procedure: spinal anesthesia
bupivacaine 0,5% 2.2 ml
Experimental: ESPB
ultrasound guided Erector Spinae Plane Block
Procedure: spinal anesthesia
bupivacaine 0,5% 2.2 ml
Procedure: ESPB
ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine
Time Frame: 24 hours
milligrams of morphine consumed in the first postoperative day
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perceived postoperative pain: Numeric Rating Scale (NRS)
Time Frame: 24 hs
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
24 hs
perceived postoperative pain: Numeric Rating Scale (NRS)
Time Frame: 48 hours
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
48 hours
side effects
Time Frame: 48 hours
occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Papa Giovanni XXIII Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

August 21, 2021

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 28, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191-19000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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