Fascia Iliaca Blocks for Total Hip Arthroplasty

Phase 4

Completed

• Conditions: THA
• Interventions: Drug: Marcaine 0.25 % Injectable Solution; Drug: Sodium chloride

• Registration Number: NCT03691337
• Lead Sponsor: New York School of Regional Anesthesia

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

Not available

Study Timeline

• Study Start: 2018-05-15
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-01
• Primary Completion: 2019-11-12
• Study Completion: 2019-12-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dosis bupivacaine	Marcaine 0.25 % Injectable Solution	Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)
Placebo	Sodium chloride	Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)
Low dosis bupivacaine	Marcaine 0.25 % Injectable Solution	Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)

Primary Outcome Measures

Name	Time	Method
Current pain assessed by numeric rating scale (NRS)	Day 7	Pain rating (Numeric Rating Scale: 0 (no pain) - 10 (worst pain)) at rest and with

Secondary Outcome Measures

Name	Time	Method
Sensory-motor blockade onset and duration	48 hours	Cold, pinprick, light touch in affected dermatomes + strength and angle of knee
Total opioid consumption	Day 7	Amount of opioid medication taken (IVPCA or oral)

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium