NCT02882633

Brief Summary

The purpose of this study is to compare lumbar plexus block to fascia iliac block done in adult patients who have undergone hip arthroscopy surgery. Visual analogue scores, opioid consumption, and quality of recovery 48 hours post operatively will be used for comparison.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 11, 2019

Status Verified

May 1, 2019

Enrollment Period

2.5 years

First QC Date

August 16, 2016

Results QC Date

April 15, 2019

Last Update Submit

May 23, 2019

Conditions

Keywords

lumbar plexus blockfascia iliac blockquality of recovery scorepain score

Outcome Measures

Primary Outcomes (2)

  • Pain Score Change

    Change in pain scores, as measured by the Visual Analog Scale (0-10). 10 is worst imaginable pain and 0 means no pain at all.

    Change from baseline through 15 minutes

  • Amount of Opiate Consumption

    Participants need for pain relief as measured by opiate consumption

    While in PACU. An average length of stay for Lumbar Plexus Block group was 165.04 min and 139.72 min for Fascia Iliaca Block group.

Secondary Outcomes (1)

  • Quality of Recovery

    Change from baseline through 24 hours

Study Arms (2)

Lumbar Plexus Block

ACTIVE COMPARATOR

Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain

Drug: 30ml bolus of bupivacaine

Fascia Iliac Block

ACTIVE COMPARATOR

Subjects will receive single shot local anesthetic, 30 ml bolus of bupivacaine, given preoperatively to help with postoperative pain

Drug: 30ml bolus of bupivacaine

Interventions

Local anesthetic

Also known as: Marcaine, Sensorcaine
Fascia Iliac BlockLumbar Plexus Block

Eligibility Criteria

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

You may qualify if:

  • Adult patients18 years and older scheduled for hip arthroscopy surgery
  • American Society of Anesthesiologists (ASA) physical status I -III
  • Mentally competent and able to give consent for enrollment in the study

You may not qualify if:

  • Chronic opioid use (use of any opioid daily or on most days of the week for more than 3 months)
  • Diagnosed peripheral neuropathy in the surgical lower extremity
  • Allergy to study medications
  • BMI \>42

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Ignacio Badiola
Organization
University of Pennsylvania

Study Officials

  • Ignacio Badiola, MD

    Univeristy of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 30, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 11, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-05

Locations