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

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.

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
Measure Time Frame
Current pain assessed by numeric rating scale (NRS) Day 0
Current pain assessed by numeric rating scale (NRS) PACU arrival
Current pain assessed by numeric rating scale (NRS) PACU discharge
Current pain assessed by numeric rating scale (NRS) 6 hours
Current pain assessed by numeric rating scale (NRS) 12 hours
Current pain assessed by numeric rating scale (NRS) 24 hours
Current pain assessed by numeric rating scale (NRS) 36 hours
Current pain assessed by numeric rating scale (NRS) 48 hours
Current pain assessed by numeric rating scale (NRS) Day 2 evening
Current pain assessed by numeric rating scale (NRS) Day 3 morning
Current pain assessed by numeric rating scale (NRS) Day 3 evening
Current pain assessed by numeric rating scale (NRS) Day 4
Current pain assessed by numeric rating scale (NRS) Day 5
Current pain assessed by numeric rating scale (NRS) Day 6
Current pain assessed by numeric rating scale (NRS) Day 7
Secondary Outcome
Measure Time Frame
Total opioid consumption PACU arrival
Total opioid consumption PACU discharge
Total opioid consumption 6 hours
Total opioid consumption 12 hours
Total opioid consumption 24 hours
Total opioid consumption 36 hours
Total opioid consumption 48 hours
Total opioid consumption Day 2 evening
Total opioid consumption Day 3 morning
Total opioid consumption Day 3 evening
Total opioid consumption Day 4
Total opioid consumption Day 5
Total opioid consumption Day 6
Total opioid consumption Day 7
Sensory-motor blockade onset and duration Day 0
Sensory-motor blockade onset and duration Post block
Sensory-motor blockade onset and duration PACU arrival
Sensory-motor blockade onset and duration PACU discharge
Sensory-motor blockade onset and duration 6 hours
Sensory-motor blockade onset and duration 12 hours
Sensory-motor blockade onset and duration 36 hours
Sensory-motor blockade onset and duration 48 hours
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

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

Overall Contact

Last Name: Gülhan Özyürek, MSc

Phone: 003289325207

Email: [email protected]

Location
Facility: Status: Contact: Ziekenhuis Oost-Limburg Catherine Vandepitte, MD 003289325207 [email protected]
Location Countries

Belgium

Verification Date

September 2018

Responsible Party

Type: Principal Investigator

Investigator Affiliation: New York School of Regional Anesthesia

Investigator Full Name: Catherine Vandepitte, M.D.

Investigator Title: Medical Doctor

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)

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov