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Clinical Trials/NCT02658240
NCT02658240
Completed
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country60 target enrollmentApril 5, 2016

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Postoperative Pain
Sponsor
University of Texas Southwestern Medical Center
Enrollment
60
Locations
1
Primary Endpoint
Postoperative Pain Score With Movement
Status
Completed
Last Updated
7 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 5, 2016
End Date
December 16, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Irina Gasanova

Associate Professor

University of Texas Southwestern Medical Center

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

Arms & Interventions

Compartment Block

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Intervention: Ropivacaine

Compartment Block

Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery

Intervention: Epinephrine

Infiltration

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Intervention: Ropivacaine

Infiltration

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Intervention: Epinephrine

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours(Postoperative 48 hours)
  • The Time to Ambulation(Postoperative 48 hours)

Study Sites (1)

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