NCT03244631

Brief Summary

Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

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

First Submitted

Initial submission to the registry

July 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

July 28, 2017

Last Update Submit

February 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Compare post-operative pain scores in the immediate post-operative period as defined by visual-analog pain scale at the time point of one hour spent in the post-anesthesia care unit (PACU).

    At the one hour point in the PACU

Secondary Outcomes (2)

  • Morphine equivalents

    At the two hour point in the PACU

  • Time spent in PACU

    Immediately after surgery

Study Arms (2)

Lumbar Plexus Block

ACTIVE COMPARATOR

A lumbar plexus 'nerve block' is a procedure in which local anesthetic ("numbing medicine") is injected around a specific group of nerves to provide pain relief directly to the nerves supplying the area of the body undergoing surgery.

Procedure: Lumbar Plexus BLock

Pericapsular Injection

ACTIVE COMPARATOR

The pericapsular injection is a procedure in which local anesthetic ("numbing medicine") is injected around the hip joint to provide direct pain relief to the area undergoing surgery.

Procedure: Pericapsular injection

Interventions

Peripheral nerve block

Lumbar Plexus Block

Injection around the area undergoing surgery

Pericapsular Injection

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient scheduled to undergo hip arthroscopy with Dr. Wolff
  • Patient age between 25 and 60 years of age.

You may not qualify if:

  • Patient has known allergy to ropivicaine or morphine.
  • Patient unable to speak/read English (No translators available in clinic site).
  • Pregnant female.
  • Patient has a pre-operative narcotic use for hip pain
  • Patient has pre-existing chronic pain disorder (i.e. fibromyalgia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Orthopedics and Sports Medicine

Chevy Chase, Maryland, 20815, United States

Location

Related Publications (1)

  • Scanaliato JP, Christensen D, Polmear MM, Salfiti C, Gaspar PS, Wolff AB. Prospective Single-Blinded Randomized Controlled Trial Comparing Pericapsular Injection Versus Lumbar Plexus Peripheral Nerve Block for Hip Arthroscopy. Am J Sports Med. 2020 Sep;48(11):2740-2746. doi: 10.1177/0363546520943580. Epub 2020 Aug 6.

Study Officials

  • Andrew Wolff, MD

    Washington Orthopaedics and Sports Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 9, 2017

Study Start

September 26, 2017

Primary Completion

September 1, 2018

Study Completion

February 1, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations