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Pain Control in Hip Arthroscopy: Comparing Lumbar Plexus Versus Peri-capsular Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03244631
Recruitment Status : Active, not recruiting
First Posted : August 9, 2017
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew B. Wolff, MD, Washington Orthopaedics and Sports Medicine

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

Condition or disease Intervention/treatment Phase
Nerve Block Hip Arthroscopy Procedure: Lumbar Plexus BLock Procedure: Pericapsular injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Single Blind Randomzied Controlled Trial Comparing Lumbar Plexus Peripheral Nerve Block Versus Peri-capsular Injection for Hip Arthroscopy
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sports Fitness

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.
Procedure: Lumbar Plexus BLock
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.
Procedure: Pericapsular injection
Injection around the area undergoing surgery




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244631


Locations
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United States, Maryland
Washington Orthopedics and Sports Medicine
Chevy Chase, Maryland, United States, 20815
Sponsors and Collaborators
Washington Orthopaedics and Sports Medicine
Investigators
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Principal Investigator: Andrew Wolff, MD Washington Orthopaedics and Sports Medicine

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Responsible Party: Andrew B. Wolff, MD, Attending Surgeon, Washington Orthopaedics and Sports Medicine
ClinicalTrials.gov Identifier: NCT03244631    
Other Study ID Numbers: 20171307
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No