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Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Epinephrine
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Nerve block, Periarticular infiltration, Ropivacaine, Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UTSW Parkland Health Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Compartment Block

Infiltration

Arm Description

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

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Outcomes

Primary Outcome Measures

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 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

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2016
Last Updated
November 26, 2018
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02658240
Brief Title
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration
Official Title
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration for Pain Management After Total Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
November 13, 2017 (Actual)
Study Completion Date
December 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Nerve block, Periarticular infiltration, Ropivacaine, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compartment Block
Arm Type
Active Comparator
Arm Description
Fascia iliaca compartment block (FICB) with ropivacaine and epinephrine after surgery
Arm Title
Infiltration
Arm Type
Active Comparator
Arm Description
Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Other Intervention Name(s)
Adrenaline
Intervention Description
0.5 mg epinephrine
Primary Outcome Measure Information:
Title
Postoperative Pain Score at Resting
Description
The Visual Analog Pain Score (VAS) at resting on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time Frame
Postoperative 48 hours
Title
Postoperative Pain Score With Movement
Description
The Visual Analog Pain Score (VAS) with movement on the scale of 10 (0= No pain, 10= Worst pain) at 48 hours postoperatively
Time Frame
Postoperative 48 hours
Secondary Outcome Measure Information:
Title
Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours
Description
Total amounts of postoperative opioid requirements for 48 hours postoperatively
Time Frame
Postoperative 48 hours
Title
The Time to Ambulation
Description
The time to ambulation during 48 hours postoperative period
Time Frame
Postoperative 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irina Gasanova, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTSW Parkland Health Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30700615
Citation
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.
Results Reference
derived

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Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

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