Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

• ClinicalTrials.gov Identifier: NCT02658240
• Recruitment Status: Completed
• First Posted: January 18, 2016
• Results First Posted: November 29, 2018
• Last Update Posted: November 29, 2018
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Irina Gasanova, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Ropivacaine; Drug: Epinephrine	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
• Actual Study Start Date: April 5, 2016
• Actual Primary Completion Date: November 13, 2017
• Actual Study Completion Date: December 16, 2017

Arms and Interventions

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 Name: 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 Name: Adrenaline

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain Score at Resting [ Time Frame: Postoperative 48 hours ]
   The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
2. Postoperative Pain Score With Movement [ Time Frame: Postoperative 48 hours ]
   The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively

Secondary Outcome Measures :

1. Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours [ Time Frame: Postoperative 48 hours ]
   Total amounts of postoperative opioid requirements for 48 hours postoperatively
2. The Time to Ambulation [ Time Frame: Postoperative 48 hours ]
   The time to ambulation during 48 hours postoperative period

Eligibility Criteria

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

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

Contacts and Locations

Locations

United States, Texas

UTSW Parkland Health Hospital System

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Irina Gasanova, MD; UT Southwestern Medical Center

  Study Documents (Full-Text)

Documents provided by Irina Gasanova, University of Texas Southwestern Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] April 1, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Irina Gasanova, Associate Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT02658240
• Other Study ID Numbers: STU 122015-022
• First Posted: January 18, 2016
• Results First Posted: November 29, 2018
• Last Update Posted: November 29, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Irina Gasanova, University of Texas Southwestern Medical Center:

Nerve block; Periarticular infiltration; Ropivacaine; Pain

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Epinephrine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents