NCT01454518

Brief Summary

The purpose of this study is to examine if ultrasound guided infiltration of local anesthetic solution around the hip joint will provide effective pain control after hip arthroscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable 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

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

October 6, 2011

Last Update Submit

March 8, 2013

Conditions

Keywords

hip arthroscopypost operative analgesia

Outcome Measures

Primary Outcomes (1)

  • Post operative opioid consumption.

    Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.

    Within 24 hours after surgery

Secondary Outcomes (1)

  • Pain scores in recovery room.

    Within 24 hours of the surgery

Study Arms (2)

Infiltration of local anesthetic

EXPERIMENTAL

30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

Procedure: Infiltration of local anesthetic

Normal Saline Injection

PLACEBO COMPARATOR

injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

Procedure: Normal Saline Injection

Interventions

30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

Infiltration of local anesthetic

injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.

Normal Saline Injection

Eligibility Criteria

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

You may qualify if:

  • hip arthroscopy
  • ages 18-80

You may not qualify if:

  • history of neurological disease
  • diabetes
  • pregnancy
  • neuropathy
  • chronic narcotic use
  • allergy to local anesthetic solution
  • inability to give consent or cooperate with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sanjay Sinha, M.D.

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 19, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

February 1, 2013

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations