Fascia Iliaca Blocks for Total Hip Arthroplasty

THA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691337
• Other study ID #: 1802
• Status: Completed
• Phase: Phase 4
• Start date: May 15, 2018
• Est. completion date: December 4, 2019

Study information

• Verified date: September 2020
• Source: New York School of Regional Anesthesia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 4, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• THA

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
New York School of Regional Anesthesia

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with movement	Day 0
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	PACU arrival
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	PACU discharge
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	6 hours
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	12 hours
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	24 hours
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	36 hours
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	48 hours
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 2 evening
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 3 morning
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 3 evening
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 4
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 5
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 6
Primary	Current pain assessed by numeric rating scale (NRS)	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with	Day 7
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	PACU arrival
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	PACU discharge
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	6 hours
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	12 hours
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	24 hours
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	36 hours
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	48 hours
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 2 evening
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 3 morning
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 3 evening
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 4
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 5
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 6
Secondary	Total opioid consumption	Amount of opioid medication taken (IVPCA or oral)	Day 7
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	Day 0
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	Post block
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	PACU arrival
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	PACU discharge
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	6 hours
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	12 hours
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	36 hours
Secondary	Sensory-motor blockade onset and duration	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee	48 hours