NCT02365961

Brief Summary

Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2015

Typical duration for phase_4

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

February 4, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 14, 2019

Completed
Last Updated

March 14, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

February 4, 2015

Results QC Date

October 31, 2018

Last Update Submit

February 20, 2019

Conditions

Hip DysplasiaFemoroacetabular ImpingementAcetabular Labrum Tear

Keywords

Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.

    3 Months

Secondary Outcomes (1)

  • Opioid Consumption

    3 Months

Other Outcomes (3)

  • Time in PACU

    Duration of PACU stay in minutes from end of surgery to discharge from PACA

  • Total Number of Episodes of Nausea and Vomiting

    From end of surgery to discharge from PACU

  • Hospital Readmission

    3 months

Study Arms (2)

FI Block

EXPERIMENTAL

Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)

Drug: ropivicaineDrug: clonidineDrug: Epinephrine

Local Injection

ACTIVE COMPARATOR

Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin

Drug: Noropin

Interventions

ropivicaineDRUG
FI Block
clonidineDRUG
FI Block
EpinephrineDRUG
FI Block
NoropinDRUG
Local Injection

Eligibility Criteria

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

You may qualify if:

  • Scheduled for outpatient hip arthroscopy
  • American Society of Anesthesiologists (ASA) 1-3

You may not qualify if:

  • Prior surgery on ipsilateral hip
  • ASA 4-6
  • Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day
  • Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes
  • Allergy to amide local anesthetics
  • Contraindication to regional anesthesia
  • BMI \> 40
  • Females who are pregnant or plan to get pregnant during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Greenville, South Carolina, 29615, United States

Location

Related Publications (1)

  • Glomset JL, Kim E, Tokish JM, Renfro SD, Seckel TB, Adams KJ, Folk J. Reduction of Postoperative Hip Arthroscopy Pain With an Ultrasound-Guided Fascia Iliaca Block: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Mar;48(3):682-688. doi: 10.1177/0363546519898205. Epub 2020 Jan 30.

    PMID: 31999469DERIVED

MeSH Terms

Conditions

Hip DislocationFemoracetabular Impingement

Interventions

ClonidineEpinephrine

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Hawkins Foundation Research Coordinator
Organization
Hawkins Foundation
info@hawkinsfoundation.com
864 454 7458

Study Officials

  • Eugene Kim, MD

    Greenville Anesthesiology - Greenville Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2015

First Posted

February 19, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 14, 2019

Results First Posted

March 14, 2019

Record last verified: 2019-02

Locations

US(1)