Hip Arthroscopy Pain Control Randomized Control Trial (RCT)
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/12/2018 |
| Start Date: | March 1, 2016 |
| End Date: | March 1, 2017 |
Liposomal Bupivacaine Versus Bupivacaine With Fascia Iliaca Blockade for Perioperative Pain Management During Hip Arthroscopy: A Double-Blinded Prospective Randomized Control Trial
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.
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.
This study is a double-blinded prospective randomized control trial. Patients will be
randomized in a 1:1 ratio to either the liposomal bupivacaine group versus bupivacaine alone.
Randomization assignment will be determined using a computer program based on random number
generation, with an equal number of treatments in blocks of 2, 4, and 6 patients. The order
of the blocks will be randomized as well. Treatment assignments will be concealed in
sequentially numbered opaque sealed envelopes (SNOSE). The anesthesia provider administering
the medication will not be an investigator of this study and will be allowed to know what
medication that is administered to ensure safety with regards to any potential medication
interactions the study medication may have with any other medication or anesthesia provided
during the operation. This study will be double blinded by having the associate investigator
(anesthesia resident/fellow) that will be conducting the post-operative pain score, Defense
and Veterans Pain Rating Scale (DVPRS) evaluations, un-aware of which medication each patient
received during the fascial iliac regional soft tissue infiltration blockade. The anesthesia
resident/fellow will remain blinded to which medication the patient received by not having
access to the patients electronic medical record, did not participate in the procedure, and
will not have access to the database created by the orthopaedics residents where this
information will be entered. The treating surgeons will also be blinded to which medication
was administered by not being present during the randomization process and will only be made
aware of which medication the patient received after the final two-week postoperative pain
assessment and oral pain medication pill count, after which patient study participation will
be concluded. The success of blinding will be evaluated by asking the patient, anesthesia
resident/fellow and treating surgeon to guess their treatment assignment the day of surgery,
during the pain score collection process and at the final two-week routine follow up
appointment.
randomized in a 1:1 ratio to either the liposomal bupivacaine group versus bupivacaine alone.
Randomization assignment will be determined using a computer program based on random number
generation, with an equal number of treatments in blocks of 2, 4, and 6 patients. The order
of the blocks will be randomized as well. Treatment assignments will be concealed in
sequentially numbered opaque sealed envelopes (SNOSE). The anesthesia provider administering
the medication will not be an investigator of this study and will be allowed to know what
medication that is administered to ensure safety with regards to any potential medication
interactions the study medication may have with any other medication or anesthesia provided
during the operation. This study will be double blinded by having the associate investigator
(anesthesia resident/fellow) that will be conducting the post-operative pain score, Defense
and Veterans Pain Rating Scale (DVPRS) evaluations, un-aware of which medication each patient
received during the fascial iliac regional soft tissue infiltration blockade. The anesthesia
resident/fellow will remain blinded to which medication the patient received by not having
access to the patients electronic medical record, did not participate in the procedure, and
will not have access to the database created by the orthopaedics residents where this
information will be entered. The treating surgeons will also be blinded to which medication
was administered by not being present during the randomization process and will only be made
aware of which medication the patient received after the final two-week postoperative pain
assessment and oral pain medication pill count, after which patient study participation will
be concluded. The success of blinding will be evaluated by asking the patient, anesthesia
resident/fellow and treating surgeon to guess their treatment assignment the day of surgery,
during the pain score collection process and at the final two-week routine follow up
appointment.
Inclusion Criteria:
1. Patient is scheduled to undergo hip arthroscopy
2. Patient is between 18-50 years of age
3. DEERS eligibility
Exclusion Criteria:
1. Patients who are on a medication pre-operatively that would prohibit them from
receiving one of the study medications
2. Patient is unable to speak/read the English language (Currently, the DVPRS has only
been scientifically validated in the English language and translating to languages
other than English would compromise the validity of the pain scale)
3. Patient has a history of previous hip arthroscopy surgery
4. The patient is pregnant - ruled out with routine urine pregnancy test the morning of
surgery in the anesthesia pre-operative unit.
5. The patient carries a pre-existing diagnosis of a pain disorder. (Example:
Fibromyalgia)
6. The patient has a previous history of narcotic pain medication abuse.
7. The patient has an allergy to one of the study medications
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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