Fascia Iliaca Blocks for Total Hip Arthroplasty

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Catherine Vandepitte, M.D.，New York School of Regional Anesthesia

Tracking Information

First Submitted Date ^ICMJE

August 1, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

May 15, 2018

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Total opioid consumption[ Time Frame: PACU arrival ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: PACU discharge ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: 6 hours ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: 12 hours ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: 24 hours ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: 36 hours ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: 48 hours ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 2 evening ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 3 morning ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 3 evening ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 4 ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 5 ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 6 ]
Amount of opioid medication taken (IVPCA or oral)
Total opioid consumption[ Time Frame: Day 7 ]
Amount of opioid medication taken (IVPCA or oral)
Sensory-motor blockade onset and duration[ Time Frame: Day 0 ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: Post block ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: PACU arrival ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: PACU discharge ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: 6 hours ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: 12 hours ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: 36 hours ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Sensory-motor blockade onset and duration[ Time Frame: 48 hours ]
Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

Descriptive Information

Brief Title ^ICMJE

Fascia Iliaca Blocks for Total Hip Arthroplasty

Official Title ^ICMJE

Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Marcaine 0.25 % Injectable Solution
Fascia iliaca block with volume 0.11 mL x subject height
Drug: Marcaine 0.25 % Injectable Solution
Fascia iliaca block with volume 0.22 mL x subject height
Drug: Sodium chloride
Fascia iliaca block with volume 0.11 mL x subject height

Study Arms

Active Comparator: Low dosis bupivacaine
Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)
Active Comparator: High dosis bupivacaine
Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)
Placebo Comparator: Placebo
Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

75

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 31, 2019

Estimated Primary Completion Date

December 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

No

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Catherine Vandepitte, M.D.，New York School of Regional Anesthesia

Study Sponsor ^ICMJE

New York School of Regional Anesthesia

Collaborators ^ICMJE

Investigators ^ICMJE

:

PRS Account

New York School of Regional Anesthesia

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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