Arthropathy of HipPhase 4NCT04574479
Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
A Phase 4 study testing Supra-inguinal fascia iliaca compartment block and Multimodal analgesia and PCA morphine pump in people with Arthropathy of Hip, run by University of Liege at 1 site in Belgium.
Trial summary
Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Hip
- What is being tested?
- Supra-inguinal fascia iliaca compartment block and Multimodal analgesia and PCA morphine pump
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Dec 2020to 2 Sep 2021
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults patients scheduled to undergo elective surgery of total hip arthroplasty by posterior surgical aboard
Who cannot join
- Patient refusal
- Allergy to used medications or local infection.
- Pregnancy
- Obesity with body mass index > 35
- History of chronic pain or fibromyalgia
- Drug (opioids) addiction
Show all 9Show fewer
- Treatment with corticosteroids for more than 6 months
- Severe kidney or liver diseases
- Mental disorders or serious neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach
Read the detailed description
ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip arthroplasty under spinal anesthesia.
The investigators would like to study the impact of supra-inguinal fascia iliaca block on postoperative pain management after total hip arthroplasty by posterior surgical approach. The principal investigator perform this block with ultrasound technique. The investigators also want to observe if this loco-regional new approach to fascia iliaca block could have influence on opioid side effects, postoperative nausea and vomiting, length of hospitalisation and first mobilisation side effects.
- Conditions
- Arthropathy of Hip
- Being tested
- Supra-inguinal fascia iliaca compartment block, Multimodal analgesia and PCA morphine pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra-inguinal fascia iliaca compartment blockProcedure or surgery
Ultrasound guided loco-regional technique as described by Desmet et al. Fascia iliaca compartment block with in-plane 40 ml ropivacaine 0,375% injection between the ilio-psoas muscle and the internal oblique muscle.
Patients in SFICB group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
Multimodal analgesia and PCA morphine pumpDrug
Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block Receives: Drug: Multimodal analgesia and PCA morphine pump |
| Fascia iliaca block | Experimental | Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery Receives: Procedure: Supra-inguinal fascia iliaca compartment block; Drug: Multimodal analgesia and PCA morphine pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid sparing
Difference in cumulated morphine consumption in the first 48 hours after surgery
Measured: 48 hours after the intervention
Secondary outcomes (2)
Opioid secondaries effects
incidence of secondary effects related to morphine consumption
Measured: 48 hours after the intervention
Pain management satisfaction: questionnaire
pain management satisfaction score by IPO (International Pain Outcomes) questionnaire
Measured: 48 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Dec 2020
- Primary completion1 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of HipStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574479
- Sponsor's protocol ID
- 2020/67
- Status last verified
- May 2022
- First submitted
- 31 Aug 2020
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.
PubMed 31272654Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print.
PubMed 35705263
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
- ClinicalTrials.gov ID
- NCT04574479
- Acronym / sponsor ID
- 2020/67
- Conditions
- Arthropathy of Hip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 5 Oct 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.
Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach
Detailed description
ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip arthroplasty under spinal anesthesia.
The investigators would like to study the impact of supra-inguinal fascia iliaca block on postoperative pain management after total hip arthroplasty by posterior surgical approach. The principal investigator perform this block with ultrasound technique. The investigators also want to observe if this loco-regional new approach to fascia iliaca block could have influence on opioid side effects, postoperative nausea and vomiting, length of hospitalisation and first mobilisation side effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Multimodal analgesia and PCA morphine pumpPlacebo group: patients have multimodal analgesia without fascia-iliaca compartment block |
| Fascia iliaca block | Experimental | Procedure: Supra-inguinal fascia iliaca compartment block, Drug: Multimodal analgesia and PCA morphine pumpPatients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients scheduled to undergo elective surgery of total hip arthroplasty by posterior surgical aboard
Key exclusion criteria (9 listed)
- Patient refusal
- Allergy to used medications or local infection.
- Pregnancy
- Obesity with body mass index > 35
- History of chronic pain or fibromyalgia
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 |
|---|---|---|
| Supra-inguinal fascia iliaca compartment blockUltrasound guided loco-regional technique as described by Desmet et al. Fascia iliaca compartment block with in-plane 40 ml ropivacaine 0,375% injection between the ilio-psoas muscle and the internal oblique muscle. Patients in SFICB group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump | Procedure or surgery | Fascia iliaca block |
| Multimodal analgesia and PCA morphine pumpPatients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump | Drug | Fascia iliaca block, Placebo |
Primary outcome
Opioid sparing
Time frame: 48 hours after the intervention
Difference in cumulated morphine consumption in the first 48 hours after surgery
2 secondary outcomes
Opioid secondaries effects
Time frame: 48 hours after the intervention
Pain management satisfaction: questionnaire
Time frame: 48 hours after the intervention
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 17 May 2022.
- Background: PubMed 31272654Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.
- Derived from this study: PubMed 35705263Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supra-inguinal fascia iliaca compartment block and Multimodal analgesia and PCA morphine pump in people with Arthropathy of Hip, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 9 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 17 May 2022. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 sparing (time frame: 48 hours after the intervention). 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 NCT04574479, which also lists 2 linked publications.
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 17 May 2022.