Arthritis of HipPhase 2/3HIPFIBNCT03069183
Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Total Hip Arthroplasty
A Phase 2/3 study testing 0.5% Ropivacaine and Normal saline in people with Arthritis of Hip, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Total hip replacement (THR) is a common and major surgical procedure performed in elderly patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic modalities could play a significant role in minimizing the risk of adverse events in the perioperative period and potentially shorten time… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis of Hip
- What is being tested?
- 0.5% Ropivacaine and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2018to 1 May 2022
- Phase
- Phase 2/3
- 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
- Patients aged 18-75, ASA I-III scheduled to undergo unilateral total hip arthroplasty.
Who cannot join
- Patients not providing informed consent.
- Refusal of treatment plan.
- Pre-existing medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
- Revision total hip arthroplasty.
- Known allergy to any of the medications being used.
- History of drug or alcohol abuse.
Show all 14Show fewer
- Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day.
- Patients with Rheumatoid Arthritis.
- Patients with psychiatric disorders.
- Patients with prior surgery in the inguinal region or inguinal hernia
- Patients unable or unwilling to use Patient Control Analgesia.
- Diabetic patients with diabetic neuropathy or those with impaired renal function (Creatinine >106).
- Patients with BMI >45.
- Patients with body weight <65kg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block on Early Post-operative Analgesia After Total Hip Arthroplasty
Total hip replacement (THR) is a common and major surgical procedure performed in elderly patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic modalities could play a significant role in minimizing the risk of adverse events in the perioperative period and potentially shorten time to discharge and recovery.
Establishing a safe and effective post-operative analgesic plan is of central importance to successful THR anesthesia care. The application of ultrasound visualization has improved the efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following THR.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia in the first 24 hours than without a block.
Read the detailed description
The search for the optimal pain treatment strategies is a work in progress. As techniques and technology evolve so should our approach for the best analgesic regimen that would minimize unwanted side effects and potential risk and more importantly improve patient satisfaction.
The literature has supported the use of peripheral nerve blocks for analgesia as well as improved functional outcome after total knee arthroplasty. The addition of peripheral nerve blocks for THR has been more controversial, as the only effective nerve block, the posterior approach to the lumbar plexus, is an advanced regional technique with potential for serious complications. The application of ultrasound visualization has improved the efficacy of the infrainguinal fascia iliaca block. However, ultrasound guided suprainguinal fascia iliaca block has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following primary hip arthroplasty.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia than that obtained using the landmark "2-pop" technique and the infrainguinal blocks.
The aim of this study is to assess whether the ultrasound guided suprainguinal fascia iliaca block can provide superior early postoperative analgesia in patients undergoing primary hip arthroplasty, and minimizing the pain immediately after the resolution of the spinal anesthetic.
The investigators propose to perform the first triple-blinded RCT examining the early analgesic efficacy of ultrasound-guided suprainguinal FICB after THR (lateral approach) under spinal anesthesia.
- Conditions
- Arthritis of Hip
- Being tested
- 0.5% Ropivacaine, Normal saline
- Keywords
- Fascia Iliaca Block, Total Hip Arthroplasty, Total Hip Replacement, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% RopivacaineDrug
Also called Naropin
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
Normal salineDrug
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% Ropivacaine | Active comparator | Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine. Receives: Drug: 0.5% Ropivacaine |
| Normal Saline | Placebo comparator | Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption at 24 hours after arrival in post-operative care unit
Opioid consumption at 24 hours after arrival in PACU amongst the various treatment groups will be our primary outcome. Opioid usage for the first 24 hours will be simply determined from the patient-controlled analgesia data in addition to oral narcotics administered.
Measured: 24 hours
Secondary outcomes (5)
Pain Scores
Numerical Rating Scale (NRS-11) for pain will be used (0=no pain, 10=terrible pain) as the secondary outcome measure. The NRS score will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours at rest and during mobilization by the treating ward nurse.
Measured: Every 4 hours after arrival in post-operative care unit for 24 hours
Respiratory Depression
Respiratory rate will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Respiratory depression will be defined as respiratory rate less than 10 breaths per minute.
Measured: Every 4 hours after arrival in post-operative care unit for 24 hours
Nausea
Nausea will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours.
Nausea and Vomiting Scale:
0 = No N \& V
- = Mild N \& V, no treatment required
- = Severe N \& V, treatment required
- = Treatment effective
- = Treatment ineffective
Measured: Every 4 hours after arrival in post-operative care unit for 24 hours
Vomiting
Vomiting will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours.
Nausea and Vomiting Scale:
0 = No N \& V
- = Mild N \& V, no treatment required
- = Severe N \& V, treatment required
- = Treatment effective
- = Treatment ineffective
Measured: Every 4 hours after arrival in post-operative care unit for 24 hours
Pruritus
Pruritus will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours.
Pruritus Scale:
0 = No pruritis
- = Mild pruritis, no treatment required
- = Severe pruritis, treatment required
- = Treatment effective
- = Treatment ineffective
Measured: Every 4 hours after arrival in post-operative care unit for 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start30 Aug 2018
- Primary completion27 Apr 2022
- Study completion1 May 2022
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 Arthritis of HipStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069183
- Sponsor's protocol ID
- 838-2017
- Acronym
- HIPFIB
- Status last verified
- Jul 2018
- First submitted
- 27 Feb 2017
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
PubMed 38762396
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. 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 on Early Post-operative Analgesia After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03069183
- Acronym / sponsor ID
- HIPFIB / 838-2017
- Conditions
- Arthritis of Hip
- Keywords
- Fascia Iliaca Block, Total Hip Arthroplasty, Total Hip Replacement, Ultrasound
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 3 Mar 2017 (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 (THR) is a common and major surgical procedure performed in elderly patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic modalities could play a significant role in minimizing the risk of adverse events in the perioperative period and potentially shorten time to discharge and recovery.
Establishing a safe and effective post-operative analgesic plan is of central importance to successful THR anesthesia care. The application of ultrasound visualization has improved the efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following THR.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia in the first 24 hours than without a block.
Detailed description
The search for the optimal pain treatment strategies is a work in progress. As techniques and technology evolve so should our approach for the best analgesic regimen that would minimize unwanted side effects and potential risk and more importantly improve patient satisfaction.
The literature has supported the use of peripheral nerve blocks for analgesia as well as improved functional outcome after total knee arthroplasty. The addition of peripheral nerve blocks for THR has been more controversial, as the only effective nerve block, the posterior approach to the lumbar plexus, is an advanced regional technique with potential for serious complications. The application of ultrasound visualization has improved the efficacy of the infrainguinal fascia iliaca block. However, ultrasound guided suprainguinal fascia iliaca block has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following primary hip arthroplasty.
The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia than that obtained using the landmark "2-pop" technique and the infrainguinal blocks.
The aim of this study is to assess whether the ultrasound guided suprainguinal fascia iliaca block can provide superior early postoperative analgesia in patients undergoing primary hip arthroplasty, and minimizing the pain immediately after the resolution of the spinal anesthetic.
The investigators propose to perform the first triple-blinded RCT examining the early analgesic efficacy of ultrasound-guided suprainguinal FICB after THR (lateral approach) under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% Ropivacaine | Active comparator | Drug: 0.5% RopivacaineUltrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine. |
| Normal Saline | Placebo comparator | Drug: Normal salineUltrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-75, ASA I-III scheduled to undergo unilateral total hip arthroplasty.
Key exclusion criteria (14 listed)
- Patients not providing informed consent.
- Refusal of treatment plan.
- Pre-existing medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
- Revision total hip arthroplasty.
- Known allergy to any of the medications being used.
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 |
|---|---|---|
| 0.5% RopivacaineAlso: NaropinUltrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine. | Drug | 0.5% Ropivacaine |
| Normal salineUltrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline. | Drug | Normal Saline |
Primary outcome
Opioid Consumption at 24 hours after arrival in post-operative care unit
Time frame: 24 hours
Opioid consumption at 24 hours after arrival in PACU amongst the various treatment groups will be our primary outcome. Opioid usage for the first 24 hours will be simply determined from the patient-controlled analgesia data in addition to oral narcotics administered.
5 secondary outcomes
Pain Scores
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Respiratory Depression
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Nausea
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Vomiting
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
Pruritus
Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours
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 12 Dec 2023.
- Derived from this study: PubMed 38762396Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.
- 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.
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 2/3 study testing 0.5% Ropivacaine and Normal saline in people with Arthritis of Hip, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 14 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 12 Dec 2023. 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 Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Consumption at 24 hours after arrival in post-operative care unit (time frame: 24 hours). 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 NCT03069183, 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 12 Dec 2023.