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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690647
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Wojciech Gola, Saint Lucas Hospital, Poland

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Analgesia Arthropathy of Hip Other: Opioid and non opioid postoperative analgesia. Other: Fascia iliaca compartment block Drug: Dexamethasone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Ultrasound Guided Suprainguinal Fascia Iliaca Compartment Block for Acute Paint Control After Elective Total Hip Replacement Using Postero-lateral Approach
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Opioid consumption [mg] [ Time Frame: 48 hours ]
    Postoperative opioid consumption was noted.

  2. Opioid related adverse effects [ Time Frame: 48 hours ]
    Postoperative incidence of nausea, vomiting, constipation and apnea were noted.

  3. Hospital stay [days] [ Time Frame: 31 days ]
    Total length of hospital stay was noted.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690647


Locations
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Poland
Saint Lucas Hospital
Konskie, Swietokrzyskie, Poland, 20-206
Sponsors and Collaborators
Saint Lucas Hospital, Poland
Investigators
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Principal Investigator: Wojciech Gola, MD Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wojciech Gola, MD, Head of The Department of Anesthesia, Saint Lucas Hospital, Poland
ClinicalTrials.gov Identifier: NCT04690647    
Other Study ID Numbers: FasiaIliaca
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Dexamethasone
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Analgesics
Sensory System Agents