THAPhase 4NCT03691337
Fascia Iliaca Blocks for Total Hip Arthroplasty
A Phase 4 study testing Marcaine 0.25 % Injectable Solution and Sodium chloride in people with THA, run by New York School of Regional Anesthesia at 1 site in Belgium.
Trial summary
The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- THA
- What is being tested?
- Marcaine 0.25 % Injectable Solution and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2018to 4 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age at screening
- Scheduled for unilateral DAA THA
- American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
- Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold
- Able to ambulate
- Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments
Who cannot join
- Previous open hip surgery
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- Contraindication to bupivacaine or morphine
- Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
- Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
- Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.
- Conditions
- THA
- Being tested
- Marcaine 0.25 % Injectable Solution, Sodium chloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcaine 0.25 % Injectable SolutionDrug
Fascia iliaca block with volume 0.11 mL x subject height
Marcaine 0.25 % Injectable SolutionDrug
Fascia iliaca block with volume 0.22 mL x subject height
Sodium chlorideDrug
Fascia iliaca block with volume 0.11 mL x subject height
| Study group | Role | What they receive |
|---|---|---|
| Low dosis bupivacaine | Active comparator | Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height) Receives: Drug: Marcaine 0.25 % Injectable Solution |
| High dosis bupivacaine | Active comparator | Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height) Receives: Drug: Marcaine 0.25 % Injectable Solution |
| Placebo | Placebo comparator | Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height) Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement
Measured: Day 0
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: PACU arrival
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: PACU discharge
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: 6 hours
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: 12 hours
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: 24 hours
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: 36 hours
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: 48 hours
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 2 evening
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 3 morning
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 3 evening
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 4
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 5
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 6
Current pain assessed by numeric rating scale (NRS)
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Measured: Day 7
Secondary outcomes (22)
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: PACU arrival
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: PACU discharge
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: 6 hours
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: 12 hours
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: 24 hours
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: 36 hours
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: 48 hours
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 2 evening
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 3 morning
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 3 evening
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 4
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 5
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 6
Total opioid consumption
Amount of opioid medication taken (IVPCA or oral)
Measured: Day 7
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: Day 0
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: Post block
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: PACU arrival
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: PACU discharge
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: 6 hours
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: 12 hours
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: 36 hours
Sensory-motor blockade onset and duration
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start15 May 2018
- Primary completion12 Nov 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THAStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York School of Regional Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Vandepitte, M.D., New York School of Regional Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691337
- Sponsor's protocol ID
- 1802
- Status last verified
- Sep 2020
- First submitted
- 1 Aug 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03691337
- Acronym / sponsor ID
- 1802
- Conditions
- THA
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- New York School of Regional AnesthesiaUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 1 Oct 2018 (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.
The development of minimal-incision techniques for total hip arthroplasty (THA) with preservation of soft tissue is generally associated with reduction of postoperative pain and increased patient comfort. Although this technique requires a smaller incision than other approaches used for hip surgery, adequate postoperative pain management remains crucial for enhanced recovery and early rehabilitation. The fascia iliaca block (FIB) is commonly used to enhance analgesia after hip replacement surgery, however the effect of FIB volume on analgesia quality and sensory-motor blockade have not been adequately studied. In this study, total postsurgical opioid consumption (morphine equivalents IV in hospital and oral at home) through the first postoperative week will be compared and extent and duration of sensory motor block through the 2-day inpatient stay will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dosis bupivacaine | Active comparator | Drug: Marcaine 0.25 % Injectable SolutionPreoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height) |
| High dosis bupivacaine | Active comparator | Drug: Marcaine 0.25 % Injectable SolutionPreoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height) |
| Placebo | Placebo comparator | Drug: Sodium chloridePreoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, at least 18 years of age at screening
- Scheduled for unilateral DAA THA
- American Society of Anesthesiologists (ASA) physical status 1, 2 or 3
- Able to demonstrate sensory function by exhibiting sensitivity to light touch, pinprick and cold
- Able to ambulate
Key exclusion criteria (7 listed)
- Previous open hip surgery
- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics
- Contraindication to bupivacaine or morphine
- Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to the hip surgery and which may confound the postsurgical assessments
- Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
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 |
|---|---|---|
| Marcaine 0.25 % Injectable SolutionFascia iliaca block with volume 0.11 mL x subject height | Drug | Low dosis bupivacaine |
| Marcaine 0.25 % Injectable SolutionFascia iliaca block with volume 0.22 mL x subject height | Drug | High dosis bupivacaine |
| Sodium chlorideFascia iliaca block with volume 0.11 mL x subject height | Drug | Placebo |
Primary outcome
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 0
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement
Current pain assessed by numeric rating scale (NRS)
Time frame: PACU arrival
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: PACU discharge
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: 6 hours
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: 12 hours
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: 24 hours
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: 36 hours
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: 48 hours
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 2 evening
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 3 morning
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 3 evening
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 4
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 5
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 6
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
Current pain assessed by numeric rating scale (NRS)
Time frame: Day 7
Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with
22 secondary outcomes
Total opioid consumption
Time frame: PACU arrival
Total opioid consumption
Time frame: PACU discharge
Total opioid consumption
Time frame: 6 hours
Total opioid consumption
Time frame: 12 hours
Total opioid consumption
Time frame: 24 hours
Total opioid consumption
Time frame: 36 hours
Total opioid consumption
Time frame: 48 hours
Total opioid consumption
Time frame: Day 2 evening
Total opioid consumption
Time frame: Day 3 morning
Total opioid consumption
Time frame: Day 3 evening
Total opioid consumption
Time frame: Day 4
Total opioid consumption
Time frame: Day 5
Total opioid consumption
Time frame: Day 6
Total opioid consumption
Time frame: Day 7
Sensory-motor blockade onset and duration
Time frame: Day 0
Sensory-motor blockade onset and duration
Time frame: Post block
Sensory-motor blockade onset and duration
Time frame: PACU arrival
Sensory-motor blockade onset and duration
Time frame: PACU discharge
Sensory-motor blockade onset and duration
Time frame: 6 hours
Sensory-motor blockade onset and duration
Time frame: 12 hours
Sensory-motor blockade onset and duration
Time frame: 36 hours
Sensory-motor blockade onset and duration
Time frame: 48 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 10 Sep 2020.
- 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 4 study testing Marcaine 0.25 % Injectable Solution and Sodium chloride in people with THA, run by New York School of Regional Anesthesia 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 6 inclusion and 7 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 10 Sep 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 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?
Current pain assessed by numeric rating scale (NRS) (time frame: Day 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2020.