Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 80
Updated:12/1/2018
Start Date:April 5, 2016
End Date:December 16, 2017

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Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial

This randomized, controlled, observer-blinded study clinical trial was designed to evaluate
ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular
infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.

Despite substantial advances in our understanding of the pathophysiology of pain and
availability of newer analgesic techniques, postoperative pain is not always effectively
treated. Optimal pain management technique balances pain relief with concerns about safety
and adverse effects associated with analgesic techniques. Currently, postoperative pain is
commonly treated with systemic opioids, which are associated with numerous adverse effects
including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and
respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid
requirements and opioid-related side effects.

Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern
Medical Center Hospitals will be randomized into one of two groups to receive either
ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg
epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine
total (Group 2) for postoperative pain management. The remaining aspect of perioperative
care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative
care will be standardized and will be similar for all patients. The duration of the
involvement in the study will be until 48 hours postoperatively.

Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2
will receive ropivacaine via periarticular infiltration prior to closing the incision.

The postoperative analgesia will be documented using the visual analog score (0=no pain,
10=worst pain). In addition, total opioid dose over the 48-h study period will be documented.
Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1,
moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be
given to any patient who complains of nausea and/or vomiting. All variables will be assessed
at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group
allocation.

Inclusion Criteria:

- Female ASA physical status 1-3 scheduled for total hip arthroplasty

- Age 18-80 years old

- Able to participate personally or by legal representative in informed consent in
English or Spanish

Exclusion Criteria:

- History of relevant drug allergy

- Age less than 18 or greater than 80 years

- Chronic opioid use or drug abuse

- Significant psychiatric disturbance

- Inability to understand the study protocol

- Refusal to provide written consent
We found this trial at
1
site
Dallas, Texas 75390
Principal Investigator: IRINA GASANOVA, MD, PhD
Phone: 214-590-0064
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mi
from
Dallas, TX
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