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Clinical Trials/NCT02933671
NCT02933671
Terminated
Phase 4

Suprainguinal Fascia Iliaca (SIFI) Block Improves Analgesia Following Total Hip Arthroplasty

Duke University1 site in 1 country11 target enrollmentAugust 1, 2017

Overview

Phase
Phase 4
Intervention
Saline
Conditions
Hip Osteoarthritis
Sponsor
Duke University
Enrollment
11
Locations
1
Primary Endpoint
Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11
Status
Terminated
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to learn if using a suprainguinal fascia iliaca (SIFI) injection technique (also called a "nerve block") that numbs the nerves going to the side and front of the upper leg will improve pain control after surgery. The SIFI technique uses a numbing solution (local anesthetics) that is injected next to nerves in the hip to reduce pain. This block may affect movement in the leg and make the legs weak. The amount of leg weakness is not known and assessment of this will be included in the study. Many institutions use the SIFI block for patients having total hip replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
March 17, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • English speaking
  • between 18 and 75 years old
  • American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total hip arthroplasty

Exclusion Criteria

  • ASA 4 or 5
  • revision hip arthroplasty
  • diagnosis of chronic pain
  • daily chronic opioid use (over 3 months of continuous opioid use)
  • inability to communicate pain scores or need for analgesia
  • acute hip fracture
  • Infection at the site of block placement
  • Age under 18 years old or greater than 75 years old
  • Pregnant women
  • Intolerance/allergy to local anesthetics

Arms & Interventions

Sham group

The same nerve block technique as above, however using an inactive solution of salt water.

Intervention: Saline

Suprainguinal Fascia Iliaca (SIFI) block

A nerve block technique using a numbing medication called ropivacaine.

Intervention: Suprainguinal fascia iliaca (SIFI) block

Suprainguinal Fascia Iliaca (SIFI) block

A nerve block technique using a numbing medication called ropivacaine.

Intervention: Ropivacaine

Sham group

The same nerve block technique as above, however using an inactive solution of salt water.

Intervention: Sham block

Outcomes

Primary Outcomes

Numeric Pain Score at 4 Hours Postoperatively, as Measured by Numerical Rating Scale (NRS) 11

Time Frame: 4 hours postoperatively

The NRS 11 ranges from 0 (no pain) to 10 (intense pain).

Secondary Outcomes

  • Motor Strength, as Measured by Dynamometry(4 hours postoperatively)
  • Numeric Pain Score at 24 Hours, as Measured by NRS 11(24 hours)
  • Cumulative Opioid Consumption(24 hours)
  • Ambulation, as Measured by Distanced Walked(post-op day 0)

Study Sites (1)

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