Back to resultsThe Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
Primary Purpose
Anesthesia, Local, Analgesia, Arthropathy of Hip
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Opioid and non opioid postoperative analgesia.
Fascia iliaca compartment block
Dexamethasone
Sponsored by
About this trial
This is an interventional supportive care trial for Anesthesia, Local
Eligibility 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
Sites / Locations
- Saint Lucas Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Opioid and non opioid postoperative analgesia.
Regional anaesthesia, opioid and non opioid postoperative analgesia.
Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia
Arm Description
Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.
Outcomes
Primary Outcome Measures
Opioid consumption [mg]
Postoperative opioid consumption was noted.
Opioid related adverse effects
Postoperative incidence of nausea, vomiting, constipation and apnea were noted.
Hospital stay [days]
Total length of hospital stay was noted.
Secondary Outcome Measures
Likert scale
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.
Full Information
NCT ID
NCT04690647
First Posted
June 4, 2020
Last Updated
December 27, 2020
Sponsor
Saint Lucas Hospital, Poland
1. Study Identification
Unique Protocol Identification Number
NCT04690647
Brief Title
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 28, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Lucas Hospital, Poland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Analgesia, Arthropathy of Hip
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Opioid and non opioid postoperative analgesia.
Arm Type
Placebo Comparator
Arm Description
Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone.
Arm Title
Regional anaesthesia, opioid and non opioid postoperative analgesia.
Arm Type
Experimental
Arm Description
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone.
Arm Title
Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia
Arm Type
Experimental
Arm Description
Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone.
Intervention Type
Other
Intervention Name(s)
Opioid and non opioid postoperative analgesia.
Intervention Description
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
Intervention Type
Other
Intervention Name(s)
Fascia iliaca compartment block
Intervention Description
Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.
Primary Outcome Measure Information:
Title
Opioid consumption [mg]
Description
Postoperative opioid consumption was noted.
Time Frame
48 hours
Title
Opioid related adverse effects
Description
Postoperative incidence of nausea, vomiting, constipation and apnea were noted.
Time Frame
48 hours
Title
Hospital stay [days]
Description
Total length of hospital stay was noted.
Time Frame
31 days
Secondary Outcome Measure Information:
Title
Likert scale
Description
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.
Time Frame
31 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech Gola, MD
Organizational Affiliation
Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Lucas Hospital
City
Konskie
State/Province
Swietokrzyskie
ZIP/Postal Code
20-206
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34064427
Citation
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.
Results Reference
derived
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The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
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