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Completed

NCT Number: NCT03691337

Fascia Iliaca Blocks for 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.

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Key information

Conditions

THA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, B-3600, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marcaine 0.25 % Injectable Solution

Drug

Fascia iliaca block with volume 0.11 mL x subject height

Sodium Chloride

Drug

Fascia iliaca block with volume 0.11 mL x subject height

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Secondary outcomes

  1. Total opioid consumption

    Time frame: PACU arrival

    Amount of opioid medication taken (IVPCA or oral)

  2. Total opioid consumption

    Time frame: PACU discharge

    Amount of opioid medication taken (IVPCA or oral)

  3. Total opioid consumption

    Time frame: 6 hours

    Amount of opioid medication taken (IVPCA or oral)

  4. Total opioid consumption

    Time frame: 12 hours

    Amount of opioid medication taken (IVPCA or oral)

  5. Total opioid consumption

    Time frame: 24 hours

    Amount of opioid medication taken (IVPCA or oral)

  6. Total opioid consumption

    Time frame: 36 hours

    Amount of opioid medication taken (IVPCA or oral)

  7. Total opioid consumption

    Time frame: 48 hours

    Amount of opioid medication taken (IVPCA or oral)

  8. Total opioid consumption

    Time frame: Day 2 evening

    Amount of opioid medication taken (IVPCA or oral)

  9. Total opioid consumption

    Time frame: Day 3 morning

    Amount of opioid medication taken (IVPCA or oral)

  10. Total opioid consumption

    Time frame: Day 3 evening

    Amount of opioid medication taken (IVPCA or oral)

  11. Total opioid consumption

    Time frame: Day 4

    Amount of opioid medication taken (IVPCA or oral)

  12. Total opioid consumption

    Time frame: Day 5

    Amount of opioid medication taken (IVPCA or oral)

  13. Total opioid consumption

    Time frame: Day 6

    Amount of opioid medication taken (IVPCA or oral)

  14. Total opioid consumption

    Time frame: Day 7

    Amount of opioid medication taken (IVPCA or oral)

  15. Sensory-motor blockade onset and duration

    Time frame: Day 0

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  16. Sensory-motor blockade onset and duration

    Time frame: Post block

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  17. Sensory-motor blockade onset and duration

    Time frame: PACU arrival

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  18. Sensory-motor blockade onset and duration

    Time frame: PACU discharge

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  19. Sensory-motor blockade onset and duration

    Time frame: 6 hours

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  20. Sensory-motor blockade onset and duration

    Time frame: 12 hours

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  21. Sensory-motor blockade onset and duration

    Time frame: 36 hours

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

  22. Sensory-motor blockade onset and duration

    Time frame: 48 hours

    Cold, pinprick, light touch in affected dermatomes + strength and angle of knee

Sponsors and collaborators

Lead sponsor

New York School of Regional Anesthesia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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