Anesthesia, LocalNCT04690647
The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.
A study testing Opioid and non opioid postoperative analgesia., Fascia iliaca compartment block and Dexamethasone in people with Anesthesia, Local and Analgesia, run by Saint Lucas Hospital, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Local, Analgesia, Arthropathy of Hip
- What is being tested?
- Opioid and non opioid postoperative analgesia., Fascia iliaca compartment block and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 28 Sep 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Saint Lucas Hospital
Gmina Końskie, Świętokrzyskie Voivodeship, 20-206
About this study
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
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.
- Conditions
- Anesthesia, Local, Analgesia, Arthropathy of Hip
- Being tested
- Opioid and non opioid postoperative analgesia., Fascia iliaca compartment block, Dexamethasone
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid and non opioid postoperative analgesia.Other
Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
Fascia iliaca compartment blockOther
Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
DexamethasoneDrug
Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Opioid and non opioid postoperative analgesia. | Placebo comparator | Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone. Receives: Other: Opioid and non opioid postoperative analgesia. |
| Regional anaesthesia, opioid and non opioid postoperative analgesia. | Experimental | Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone. Receives: Other: Opioid and non opioid postoperative analgesia.; Other: Fascia iliaca compartment block |
| Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia | Experimental | Group of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone. Receives: Other: Opioid and non opioid postoperative analgesia.; Other: Fascia iliaca compartment block; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption [mg]
Postoperative opioid consumption was noted.
Measured: 48 hours
Opioid related adverse effects
Postoperative incidence of nausea, vomiting, constipation and apnea were noted.
Measured: 48 hours
Hospital stay [days]
Total length of hospital stay was noted.
Measured: 31 days
Secondary outcomes (1)
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.
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start28 Sep 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Lucas Hospital, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Gola, Saint Lucas Hospital, Poland
- Investigators
- Wojciech Gola, MD, Principal investigator, Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690647
- Sponsor's protocol ID
- FasiaIliaca
- Status last verified
- Dec 2020
- First submitted
- 4 Jun 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34064427
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04690647
- Acronym / sponsor ID
- FasiaIliaca
- Conditions
- Anesthesia, Local, Analgesia, Arthropathy of Hip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Saint Lucas Hospital, PolandUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid and non opioid postoperative analgesia. | Placebo comparator | Other: Opioid and non opioid postoperative analgesia.Group of patients with opioid and non opioid based postoperative analgesia without preoperative regional anaesthesia and dexamethasone. |
| Regional anaesthesia, opioid and non opioid postoperative analgesia. | Experimental | Other: Opioid and non opioid postoperative analgesia., Other: Fascia iliaca compartment blockGroup of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and without preoperative dexamethasone. |
| Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia | Experimental | Other: Opioid and non opioid postoperative analgesia., Other: Fascia iliaca compartment block, Drug: DexamethasoneGroup of patients with opioid and non opioid based postoperative analgesia with preoperative regional anaesthesia and dexamethasone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- contraindications to spinal anesthesia and regional blocks
- previously coexisting chronic pain
- previously opioids intake
- BMI>30kg/m2
- allergy to drugs using during study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid and non opioid postoperative analgesia.Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol. | Other | Opioid and non opioid postoperative analgesia., Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia, Regional anaesthesia, opioid and non opioid postoperative analgesia. |
| Fascia iliaca compartment blockUltrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol. | Other | Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia, Regional anaesthesia, opioid and non opioid postoperative analgesia. |
| DexamethasoneDexamethasone will be administered preoperatively in a dose of 0,1 mg/kg. | Drug | Regional anaesthesia, dexamethasone, opioid and non opioid postoperative analgesia |
Primary outcome
Opioid consumption [mg]
Time frame: 48 hours
Postoperative opioid consumption was noted.
Opioid related adverse effects
Time frame: 48 hours
Postoperative incidence of nausea, vomiting, constipation and apnea were noted.
Hospital stay [days]
Time frame: 31 days
Total length of hospital stay was noted.
1 secondary outcome
Likert scale
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Derived from this study: PubMed 34064427Gola 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wojciech Gola, MD principal investigator
Head of the Department of Anesthesia and Intensive Care Unit, Saint Lucas Hospital, Konskie, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid and non opioid postoperative analgesia., Fascia iliaca compartment block and Dexamethasone in people with Anesthesia, Local and Analgesia, run by Saint Lucas Hospital, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption [mg] (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.