- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244631
Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection
February 11, 2020 updated by: Andrew B. Wolff, MD, Washington Orthopaedics and Sports Medicine
Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy
Comparison of lumbar plexus nerve block versus pericapsular injection for pain control during hip arthroscopy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare two different methods of pain control during and after hip arthroscopy surgery.
It is not clear which of many different pain control methods are ideal to reduce pain for patients; consequently, the investigators are performing this study to compare the two main choices for pain control commonly used in order to identify if either is superior to the other.
Study Type
Interventional
Enrollment (Actual)
64
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
-
-
Maryland
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Chevy Chase, Maryland, United States, 20815
- Washington Orthopedics and Sports Medicine
-
-
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
23 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient scheduled to undergo hip arthroscopy with Dr. Wolff
- Patient age between 25 and 60 years of age.
Exclusion Criteria:
- 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)
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lumbar Plexus Block
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.
|
Peripheral nerve block
|
Active Comparator: Pericapsular Injection
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.
|
Injection around the area undergoing surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain score
Time Frame: At the one hour point in the PACU
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine equivalents
Time Frame: At the two hour point in the PACU
|
Compare the total morphine equivalents of opioids provided in the PACU within the first two hours of time spent in the PACU
|
At the two hour point in the PACU
|
Time spent in PACU
Time Frame: Immediately after surgery
|
Compare the overall time spent in the PACU as defined by time to arrival to time to discharge vitals.
|
Immediately after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Wolff, MD, Washington Orthopaedics and Sports Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
September 26, 2017
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
February 1, 2020
Study Registration Dates
First Submitted
July 28, 2017
First Submitted That Met QC Criteria
August 4, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 20171307
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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