- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01907191
Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy
August 12, 2022 updated by: Saint Francis Care
Comparison of Bupivacaine to Liposomal Bupivacaine for Ultrasound Guided Periarticular Hip Infiltration for Postoperative Analgesia After Hip Arthroscopy.
This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine.
Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing hip arthroscopy experience moderate to severe postoperative pain.
Effective pain control after surgery is an important component in the overall management of these patients.
Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction.
Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications.
Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.
Study Type
Interventional
Enrollment (Actual)
23
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients having hip arthroscopy
Exclusion Criteria:
- History of neurologic disease, neuropathy, diabetes
- Allergy to local anesthetic solution
- Chronic use of narcotics
- Inability to give consent/cooperate with study
- History of previous hip arthroscopy on the ipsilateral side
- Pregnancy
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liposomal bupivacaine
Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy
|
(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy
Other Names:
|
Active Comparator: Bupivacaine
Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
|
(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Time Frame: Post Operative Day 1, 2 & 3
|
Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3.
|
Post Operative Day 1, 2 & 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Scores
Time Frame: Post Operative Day 1, 2 & 3
|
Analysis of pain scores (at rest and ambulation) during hospital stay.
Measured on a 10 point pain scale (1 being no pain and 10 being worst pain imaginable)
|
Post Operative Day 1, 2 & 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Reporting Sleep Disturbance
Time Frame: Post Operative Day 1, 2 & 3
|
Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 & 3)
|
Post Operative Day 1, 2 & 3
|
Satisfaction With Pain Management
Time Frame: Post Operative Day 1, 2 & 3
|
Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)
|
Post Operative Day 1, 2 & 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sanjay Sinha, MD, Saint Francis Hospital and Medical Center
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
July 1, 2013
Primary Completion (Actual)
January 30, 2019
Study Completion (Actual)
January 30, 2019
Study Registration Dates
First Submitted
June 28, 2013
First Submitted That Met QC Criteria
July 18, 2013
First Posted (Estimate)
July 24, 2013
Study Record Updates
Last Update Posted (Actual)
August 16, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-06-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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