Fascia Iliaca Blocks for Total Hip Arthroplasty

New York School of Regional Anesthesia

Status and phase: Completed; Phase 4

Conditions: THA

Treatments: Drug: Marcaine 0.25 % Injectable Solution; Drug: Sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT03691337

1802

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Low dosis bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Marcaine 0.25 % Injectable Solution

Drug: Marcaine 0.25 % Injectable Solution

High dosis bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: Marcaine 0.25 % Injectable Solution

Drug: Marcaine 0.25 % Injectable Solution

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium chloride