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Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Irina Gasanova, University of Texas Southwestern Medical Center

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.

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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


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658240


Locations
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United States, Texas
UTSW Parkland Health Hospital System
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Irina Gasanova, MD UT Southwestern Medical Center
  Study Documents (Full-Text)

Documents provided by Irina Gasanova, University of Texas Southwestern Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
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:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
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