The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.

December 27, 2020 updated by: Wojciech Gola, Saint Lucas Hospital, Poland

The Efficacy of Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block for Acute Paint Control After Elective Total Hip Replacement Using Postero-lateral Approach

Total hip replacement surgery is one of the most common orthopedic interventions. Proper anaesthesia and adequate analgesia is one of the key interests of attending anaesthetist. Recent studies show that ultrasound guided suprainguinal fascia iliaca compartment block may play a significant role in proper management of pain after these procedures. The aim of this study was to assess the clinical usefulness and compare different methods of anaesthesia for total hip replacement surgery via posterolateral approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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

  • Poland
    • Swietokrzyskie
      • Konskie, Swietokrzyskie, Poland, 20-206
        • Saint Lucas Hospital

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-75 years old
  • informed consent to participate in the study
  • ASA score I-III
  • BMI -19-30kg/m2
  • qualified for total hip replacement
  • no contraindication to used anesthesia and drugs

Exclusion Criteria:

  • contraindications to spinal anesthesia and regional blocks
  • previously coexisting chronic pain
  • previously opioids intake
  • BMI>30kg/m2
  • allergy to drugs using during study
  • mental status preventing the usage of patient controlled analgesia pump

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: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Opioid and non opioid postoperative analgesia.
Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.
Other: Opioid and non opioid postoperative analgesia.
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
EXPERIMENTAL: Regional anaesthesia, opioid and non opioid postoperative analgesia.
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.
Other: Opioid and non opioid postoperative analgesia.
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
Other: Fascia iliaca compartment block
Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
EXPERIMENTAL: Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.
Other: Opioid and non opioid postoperative analgesia.
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
Other: Fascia iliaca compartment block
Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
Drug: Dexamethasone
Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption [mg]
Time Frame: 48 hours
Postoperative opioid consumption was noted.
48 hours
Opioid related adverse effects
Time Frame: 48 hours
Postoperative incidence of nausea, vomiting, constipation and apnea were noted.
48 hours
Hospital stay [days]
Time Frame: 31 days
Total length of hospital stay was noted.
31 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert scale
Time Frame: 31 days
Likert scale value was noted at the discharge. Value of 1 corresponded with strong dissatisfaction, value of 2 with dissatisfaction, value of 3 with neither satisfaction nor dissatisfaction, value of 4 with satisfaction, value of 5 with strong satisfaction.
31 days

Collaborators and Investigators

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

Sponsor

Saint Lucas Hospital, Poland

Investigators

  • Principal Investigator: Wojciech Gola, MD, Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 28, 2018

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

December 27, 2020

First Posted (ACTUAL)

December 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 27, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FasiaIliaca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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