Fascia Iliaca Blocks for Total Hip Arthroplasty

NCT ID: NCT03691337

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2019-12-04

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.

Conditions

THA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low dosis bupivacaine

Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height)

Group Type: ACTIVE_COMPARATOR

Marcaine 0.25 % Injectable Solution

Intervention Type: DRUG

Fascia iliaca block with volume 0.11 mL x subject height

High dosis bupivacaine

Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height)

Group Type: ACTIVE_COMPARATOR

Marcaine 0.25 % Injectable Solution

Intervention Type: DRUG

Fascia iliaca block with volume 0.22 mL x subject height

Placebo

Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height)

Group Type: PLACEBO_COMPARATOR

Sodium chloride

Intervention Type: DRUG

Fascia iliaca block with volume 0.11 mL x subject height

Interventions

Marcaine 0.25 % Injectable Solution

Fascia iliaca block with volume 0.11 mL x subject height

Intervention Type: DRUG

Marcaine 0.25 % Injectable Solution

Fascia iliaca block with volume 0.22 mL x subject height

Intervention Type: DRUG

Sodium chloride

Fascia iliaca block with volume 0.11 mL x subject height

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

New York School of Regional Anesthesia

OTHER

Sponsor Role: lead

Responsible Party

Catherine Vandepitte, M.D.

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Countries

Belgium

Other Identifiers

1802

Identifier Type: -

Identifier Source: org_study_id