Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
Fascia Iliaca Blocks for Total Hip Arthroplasty
Sponsors
Source
New York School of Regional Anesthesia
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief 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. 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.
Overall Status
Recruiting
Start Date
2018-05-15
Completion Date
2019-03-31
Primary Completion Date
2018-12-31
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Current pain assessed by numeric rating scale (NRS) |
Day 0 |
|
Current pain assessed by numeric rating scale (NRS) |
PACU arrival |
|
Current pain assessed by numeric rating scale (NRS) |
PACU discharge |
|
Current pain assessed by numeric rating scale (NRS) |
6 hours |
|
Current pain assessed by numeric rating scale (NRS) |
12 hours |
|
Current pain assessed by numeric rating scale (NRS) |
24 hours |
|
Current pain assessed by numeric rating scale (NRS) |
36 hours |
|
Current pain assessed by numeric rating scale (NRS) |
48 hours |
|
Current pain assessed by numeric rating scale (NRS) |
Day 2 evening |
|
Current pain assessed by numeric rating scale (NRS) |
Day 3 morning |
|
Current pain assessed by numeric rating scale (NRS) |
Day 3 evening |
|
Current pain assessed by numeric rating scale (NRS) |
Day 4 |
|
Current pain assessed by numeric rating scale (NRS) |
Day 5 |
|
Current pain assessed by numeric rating scale (NRS) |
Day 6 |
|
Current pain assessed by numeric rating scale (NRS) |
Day 7 |
Secondary Outcome
Measure |
Time Frame |
|
Total opioid consumption |
PACU arrival |
|
Total opioid consumption |
PACU discharge |
|
Total opioid consumption |
6 hours |
|
Total opioid consumption |
12 hours |
|
Total opioid consumption |
24 hours |
|
Total opioid consumption |
36 hours |
|
Total opioid consumption |
48 hours |
|
Total opioid consumption |
Day 2 evening |
|
Total opioid consumption |
Day 3 morning |
|
Total opioid consumption |
Day 3 evening |
|
Total opioid consumption |
Day 4 |
|
Total opioid consumption |
Day 5 |
|
Total opioid consumption |
Day 6 |
|
Total opioid consumption |
Day 7 |
|
Sensory-motor blockade onset and duration |
Day 0 |
|
Sensory-motor blockade onset and duration |
Post block |
|
Sensory-motor blockade onset and duration |
PACU arrival |
|
Sensory-motor blockade onset and duration |
PACU discharge |
|
Sensory-motor blockade onset and duration |
6 hours |
|
Sensory-motor blockade onset and duration |
12 hours |
|
Sensory-motor blockade onset and duration |
36 hours |
|
Sensory-motor blockade onset and duration |
48 hours |
Enrollment
75
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Fascia iliaca block with volume 0.11 mL x subject height
Arm Group Label
Low dosis bupivacaine
Intervention Type
Drug
Intervention Name
Description
Fascia iliaca block with volume 0.22 mL x subject height
Arm Group Label
High dosis bupivacaine
Intervention Type
Drug
Intervention Name
Description
Fascia iliaca block with volume 0.11 mL x subject height
Arm Group Label
Placebo
Eligibility
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Contact
Location
Facility |
Status |
Contact |
|
Ziekenhuis Oost-Limburg Genk Limburg B-3600 Belgium |
Recruiting |
Location Countries
Country
Belgium
Verification Date
2018-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
New York School of Regional Anesthesia
Investigator Full Name
Catherine Vandepitte, M.D.
Investigator Title
Medical Doctor
Has Expanded Access
No
Number Of Arms
3
Intervention Browse
Mesh Term
Bupivacaine
Pharmaceutical Solutions
Arm Group
Arm Group Label
Low dosis bupivacaine
Arm Group Type
Active Comparator
Description
Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)
Arm Group Label
High dosis bupivacaine
Arm Group Type
Active Comparator
Description
Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
August 1, 2018
Study First Submitted Qc
September 28, 2018
Study First Posted
October 1, 2018
Last Update Submitted
September 28, 2018
Last Update Submitted Qc
September 28, 2018
Last Update Posted
October 1, 2018
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.