Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Epinephrine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UTSW Parkland Health Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Irina Gasanova, MD, UT Southwestern Medical Center

Publications and helpful links

General Publications

• Gasanova I, Alexander JC, Estrera K, Wells J, Sunna M, Minhajuddin A, Joshi GP. Ultrasound-guided suprainguinal fascia iliaca compartment block versus periarticular infiltration for pain management after total hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2019 Feb;44(2):206-211. doi: 10.1136/rapm-2018-000016.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2016
• Primary Completion (Actual): November 13, 2017
• Study Completion (Actual): December 16, 2017

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 15, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Ropivacaine; Nerve block; Periarticular infiltration
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Ropivacaine; Epinephrine
• Other Study ID Numbers: STU 122015-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED