Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Epinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compartment Block<br>Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery | Drug: Ropivacaine<br>* Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL<br>Drug: Epinephrine<br>* 0.5 mg epinephrine<br>* Other names: Adrenaline;|
| Active Comparator: Infiltration<br>Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision | Drug: Ropivacaine<br>* Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL<br>Drug: Epinephrine<br>* 0.5 mg epinephrine<br>* Other names: Adrenaline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Score at Resting | The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Postoperative 48 hours | 
| Postoperative Pain Score With Movement | The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively | Postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours | Total amounts of postoperative opioid requirements for 48 hours postoperatively | Postoperative 48 hours | 
| The Time to Ambulation | The time to ambulation during 48 hours postoperative period | Postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nerve block, Periarticular infiltration, Ropivacaine, Pain