Fascia Iliaca Blocks for Total Hip Arthroplasty

Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach 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.

Study Overview

• Status: Completed
• Conditions: THA
• Intervention / Treatment: Drug: Marcaine 0.25 % Injectable Solution; Drug: Marcaine 0.25 % Injectable Solution; Drug: Sodium chloride

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, B-3600
      • Ziekenhuis Oost-Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dosis bupivacaine; Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)	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
Active Comparator: High dosis bupivacaine; Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)	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
Placebo Comparator: Placebo; Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)	Drug: Sodium chloride; Fascia iliaca block with volume 0.11 mL x subject height

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: New York School of Regional Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): November 12, 2019
• Study Completion (Actual): December 4, 2019

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Bupivacaine
• Other Study ID Numbers: 1802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No