NCT02658240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2017

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 29, 2018

Completed
Last Updated

November 29, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

January 14, 2016

Results QC Date

October 3, 2018

Last Update Submit

November 26, 2018

Conditions

Postoperative Pain

Keywords

Nerve blockPeriarticular infiltrationRopivacainePain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Oral Morphine Equivalents of Postoperative Opioid Requirements for 48 Hours

    Postoperative 48 hours

  • The Time to Ambulation

    Postoperative 48 hours

Study Arms (2)

Compartment Block

ACTIVE COMPARATOR

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

Drug: RopivacaineDrug: Epinephrine

Infiltration

ACTIVE COMPARATOR

Periarticular infiltration with ropivacaine and epinephrine prior to closing the incision

Drug: RopivacaineDrug: Epinephrine

Interventions

RopivacaineDRUG

Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL

Compartment BlockInfiltration
EpinephrineDRUG

0.5 mg epinephrine

Also known as: Adrenaline
Compartment BlockInfiltration

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTSW Parkland Health Hospital System

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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.

    PMID: 30700615DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

RopivacaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Irina Gasanova
Organization
UT Southwestern Medical Center
Irina.Gasanova@UTSouthwestern.edu
4694191997

Study Officials

  • Irina Gasanova, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 18, 2016

Study Start

April 5, 2016

Primary Completion

November 13, 2017

Study Completion

December 16, 2017

Last Updated

November 29, 2018

Results First Posted

November 29, 2018

Record last verified: 2018-11

Locations

US(1)