Fascia Iliaca Blocks for Total Hip Arthroplasty
Fascia Iliaca Block for Analgesia in Unilateral Direct Anterior Approach Total Hip Arthroplasty
| Sponsors |
Lead Sponsor: New York School of Regional Anesthesia |
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| Source | 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. |
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| Overall Status | Recruiting | ||||||||||||||||||||||||||||||||||||||||||||||
| Start Date | May 15, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||
| Completion Date | March 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | December 31, 2018 | ||||||||||||||||||||||||||||||||||||||||||||||
| Phase | Phase 4 | ||||||||||||||||||||||||||||||||||||||||||||||
| Study Type | Interventional | ||||||||||||||||||||||||||||||||||||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 75 | ||||||||||||||||||||||||||||||||||||||||||||||
| Condition | |||||||||||||||||||||||||||||||||||||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Marcaine 0.25 % Injectable Solution Description: Fascia iliaca block with volume 0.11 mL x subject height Arm Group Label: Low dosis bupivacaine Intervention Type: Drug Intervention Name: Marcaine 0.25 % Injectable Solution Description: Fascia iliaca block with volume 0.22 mL x subject height Arm Group Label: High dosis bupivacaine Intervention Type: Drug Intervention Name: Sodium chloride Description: Fascia iliaca block with volume 0.11 mL x subject height Arm Group Label: Placebo |
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| 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 Gender: All Minimum Age: 18 Years Maximum Age: N/A Healthy Volunteers: Accepts Healthy Volunteers |
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| Overall Contact |
Last Name: Gülhan Özyürek, MSc Phone: 003289325207 Email: [email protected] |
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| Location |
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| Location Countries |
Belgium |
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| Verification Date |
September 2018 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: New York School of Regional Anesthesia Investigator Full Name: Catherine Vandepitte, M.D. Investigator Title: Medical Doctor |
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| Has Expanded Access | No | ||||||||||||||||||||||||||||||||||||||||||||||
| Number Of Arms | 3 | ||||||||||||||||||||||||||||||||||||||||||||||
| Arm Group |
Label: Low dosis bupivacaine Type: Active Comparator Description: Preoperative fascia iliaca block with Marcaine 0.25% (0.11 mL x subject height) Label: High dosis bupivacaine Type: Active Comparator Description: Preoperative fascia iliaca block with Marcaine 0.25% (0.22 mL x subject height) Label: Placebo Type: Placebo Comparator Description: Preoperative fascia iliaca block with Sodium Chloride 0.9% (0.11 mL x subject height) |
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| Patient Data | Undecided | ||||||||||||||||||||||||||||||||||||||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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