Clinical trial NCT03691337: Fascia Iliaca Blocks for Total Hip Arthroplasty
Official title: Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: THA
Lead sponsor: New York School of Regional Anesthesia
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 0
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: PACU arrival
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: PACU discharge
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: 6 hours
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: 12 hours
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: 24 hours
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: 36 hours
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: 48 hours
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 2 evening
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 3 morning
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 3 evening
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 4
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 5
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 6
measure: Current pain assessed by numeric rating scale (NRS)
timeFrame: Day 7
Secondary outcomes:
measure: Total opioid consumption
timeFrame: PACU arrival
measure: Total opioid consumption
timeFrame: PACU discharge
measure: Total opioid consumption
timeFrame: 6 hours
measure: Total opioid consumption
timeFrame: 12 hours
measure: Total opioid consumption
timeFrame: 24 hours
measure: Total opioid consumption
timeFrame: 36 hours
measure: Total opioid consumption
timeFrame: 48 hours
measure: Total opioid consumption
timeFrame: Day 2 evening
measure: Total opioid consumption
timeFrame: Day 3 morning
measure: Total opioid consumption
timeFrame: Day 3 evening
measure: Total opioid consumption
timeFrame: Day 4
measure: Total opioid consumption
timeFrame: Day 5
measure: Total opioid consumption
timeFrame: Day 6
measure: Total opioid consumption
timeFrame: Day 7
measure: Sensory-motor blockade onset and duration
timeFrame: Day 0
measure: Sensory-motor blockade onset and duration
timeFrame: Post block
measure: Sensory-motor blockade onset and duration
timeFrame: PACU arrival
measure: Sensory-motor blockade onset and duration
timeFrame: PACU discharge
measure: Sensory-motor blockade onset and duration
timeFrame: 6 hours
measure: Sensory-motor blockade onset and duration
timeFrame: 12 hours
measure: Sensory-motor blockade onset and duration
timeFrame: 36 hours
measure: Sensory-motor blockade onset and duration
timeFrame: 48 hours
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: