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

NCT ID: NCT04690647

Last Updated: 2020-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-28

Study Completion Date

2019-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia, Local Analgesia Arthropathy of Hip

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Opioid and non opioid postoperative analgesia.

Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.

Group Type PLACEBO_COMPARATOR

Opioid and non opioid postoperative analgesia.

Intervention Type OTHER

Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.

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.

Group Type EXPERIMENTAL

Opioid and non opioid postoperative analgesia.

Intervention Type OTHER

Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.

Fascia iliaca compartment block

Intervention Type OTHER

Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.

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.

Group Type EXPERIMENTAL

Opioid and non opioid postoperative analgesia.

Intervention Type OTHER

Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.

Fascia iliaca compartment block

Intervention Type OTHER

Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.

Dexamethasone

Intervention Type DRUG

Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.

Interventions

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Opioid and non opioid postoperative analgesia.

Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.

Intervention Type 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.

Intervention Type OTHER

Dexamethasone

Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint Lucas Hospital, Poland

OTHER

Sponsor Role lead

Responsible Party

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Wojciech Gola

MD, Head of The Department of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wojciech Gola, MD

Role: PRINCIPAL_INVESTIGATOR

Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland

Locations

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Saint Lucas Hospital

Gmina Końskie, Świętokrzyskie Voivodeship, Poland

Site Status

Countries

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Poland

References

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Gola W, Bialka S, Owczarek AJ, Misiolek H. Effectiveness of Fascia Iliaca Compartment Block after Elective Total Hip Replacement: A Prospective, Randomized, Controlled Study. Int J Environ Res Public Health. 2021 May 4;18(9):4891. doi: 10.3390/ijerph18094891.

Reference Type DERIVED
PMID: 34064427 (View on PubMed)

Other Identifiers

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FasiaIliaca

Identifier Type: -

Identifier Source: org_study_id