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Liposomal Bupivacaine Versus Bupivacaine With Fascia Iliaca Blockade for Perioperative Pain Management During Hip Arthroscopy: A Double-Blinded Prospective Randomized Control Trial
Sponsor study identifier
interventional
74
1 country
1
Study Start
March 1, 2016
Actual (reported)Primary Completion
March 1, 2017
Actual (reported)Study Completion
March 1, 2017
Actual (reported)Femoroacetabular impingement is a pathologic process within the hip joint that results from a mechanical discord between the femoral head and neck and the acetabulum that results in chronic hip pain, hip labral tears and early progression of osteoarthritis of the hip.1, 2 Historically an open surgical hip dislocation was performed to treat patients with this condition, however with recent advances in arthroscopy, patients more commonly now undergo arthroscopic hip surgery. From a pain management standpoint, previous attempts to provide peri-operative analgesia included intraarticular or portal analgesic injections. More recently, regional anesthesia techniques are being employed to provide more reliable and longer lasting post-operative pain control.3, 4 Currently, there are several local anesthetics available for regional anesthesia. However, they only provide an average of 12-18 hours of post-operative pain control following a single injection.5 Bupivacaine is a local anesthetic that has been used for many years by multiple routes to control post-operative pain. A new formulation of the medication prolongs the release of the active ingredient after a single injection and has been shown to result in up to 72 hours of post-operative analgesia.6, 7 To the investigator's knowledge, there has not been any studies in the literature comparing a historical control local anesthetic to this new formulation of liposomal bupivacaine via a fascial iliaca regional soft tissue infiltration blockade to provide post operative pain control following hip arthroscopy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2017
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2016
Actual (reported)October 12, 2016
Actual (reported)October 27, 2016
Actual (reported)March 1, 2017
Actual (reported)March 1, 2017
Actual (reported)Pain
To compare post-operative pain scores between the two treatments groups. To advance this objective, DVPRS (Defense and Veterans Pain Rating Scale) scores will be collected and analyzed at discharge and on post-operative days one, two, and three. The investigator's hypothesize that the addition of liposomal bupivacaine will result in a 2-point improvement in DVPRS scores during the post-operative period.
Immediate Post-operative
Opioid Use
Immediate Post-operative
Bupivicaine fascial iliaca regional soft tissue infiltration blockade
Bupivacaine plus liposomal bupivacaine fascial iliaca regional soft tissue infiltration blockade
Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy)
Utilizing: Defense and Veterans Pain Rating Scale (DVPRS)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Liposomal Bupivacaine
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry recordWalter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Michael Kent, MD
Walter Reed National Military Medical Center
74 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2016
First Posted
October 27, 2016
Study Start
March 1, 2016
Actual (reported)Patient reported as needed (prn) pain medication usage
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
March 1, 2017
Actual (reported)Study Completion
March 1, 2017
Actual (reported)Last Updated
January 10, 2018
Record last verified: 2018-01
Individual participant data will be combined together for data analysis.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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