- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454518
Local Infiltration Analgesia for Hip Arthroscopy
March 8, 2013 updated by: Saint Francis Care
Effectiveness of Ultrasound Guided Hip Infiltration With Local Anesthetic Solution for Pain Control After Hip Arthroscopy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06105
- Saint Francis Hospital and Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hip arthroscopy
- ages 18-80
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Infiltration of local anesthetic
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
|
30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
|
|
Placebo Comparator: Normal Saline Injection
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
|
injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative opioid consumption.
Time Frame: Within 24 hours after surgery
|
Amount in milligrams of opioid consumption post surgery in the recovery room and for a 24 hour period.
|
Within 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores in recovery room.
Time Frame: Within 24 hours of the surgery
|
Mesures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 24 hour period after discharge from recovery room.
|
Within 24 hours of the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, M.D., Saint Francis Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 18, 2011
First Posted (Estimate)
October 19, 2011
Study Record Updates
Last Update Posted (Estimate)
March 11, 2013
Last Update Submitted That Met QC Criteria
March 8, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-08-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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