Hip Pain ChronicPhase 4NCT02947178
Hip Arthroscopy Pain Control Randomized Control Trial (RCT)
A Phase 4 study testing Fascial iliac regional soft tissue infiltration blockade, Pain Score Survey and Pill Count in people with Hip Pain Chronic and Anesthesia, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Pain Chronic, Anesthesia, Bupivacaine
- What is being tested?
- Fascial iliac regional soft tissue infiltration blockade, Pain Score Survey and Pill Count
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 1 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient is scheduled to undergo hip arthroscopy
- Patient is between 18-50 years of age
- DEERS eligibility
Who cannot join
- Patients who are on a medication pre-operatively that would prohibit them from receiving one of the study medications
- 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)
- Patient has a history of previous hip arthroscopy surgery
- The patient is pregnant - ruled out with routine urine pregnancy test the morning of surgery in the anesthesia pre-operative unit.
- The patient carries a pre-existing diagnosis of a pain disorder. (Example: Fibromyalgia)
- The patient has a previous history of narcotic pain medication abuse.
- The patient has an allergy to one of the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hip Pain Chronic, Anesthesia, Bupivacaine
- Being tested
- Fascial iliac regional soft tissue infiltration blockade, Pain Score Survey, Pill Count, Bupivacaine, Liposomal Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascial iliac regional soft tissue infiltration blockadeProcedure or surgery
Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy)
Pain Score SurveyBehavioural
Utilizing: Defense and Veterans Pain Rating Scale (DVPRS)
Pill CountBehavioural
Patient reported as needed (prn) pain medication usage
BupivacaineDrug
Liposomal BupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivicaine | Active comparator | Bupivicaine fascial iliaca regional soft tissue infiltration blockade Receives: Procedure: Fascial iliac regional soft tissue infiltration blockade; Behavioral: Pain Score Survey; Behavioral: Pill Count; Drug: Bupivacaine |
| Bupivacaine plus liposomal bupivacaine | Active comparator | Bupivacaine plus liposomal bupivacaine fascial iliaca regional soft tissue infiltration blockade Receives: Procedure: Fascial iliac regional soft tissue infiltration blockade; Behavioral: Pain Score Survey; Behavioral: Pill Count; Drug: Bupivacaine; Drug: Liposomal Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediate Post-operative
Secondary outcomes (1)
Opioid Use
To compare overall post-operative opioid use between the two treatment groups. Opioid usage will be quantified using a patient-reported medication diary and a pill count. The investigator's hypothesize that the addition of liposomal bupivacaine will result in a decrease in total opioid use during the post-operative time period.
Measured: Immediate Post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael Kent, MD, Study director, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947178
- Sponsor's protocol ID
- 500025
- Status last verified
- Jan 2018
- First submitted
- 12 Oct 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will be combined together for data analysis.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Versus Bupivacaine With Fascia Iliaca Blockade for Perioperative Pain Management During Hip Arthroscopy: A Double-Blinded Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02947178
- Acronym / sponsor ID
- 500025
- Conditions
- Hip Pain Chronic, Anesthesia, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivicaine | Active comparator | Procedure: Fascial iliac regional soft tissue infiltration blockade, Behavioral: Pain Score Survey, Behavioral: Pill Count, Drug: BupivacaineBupivicaine fascial iliaca regional soft tissue infiltration blockade |
| Bupivacaine plus liposomal bupivacaine | Active comparator | Procedure: Fascial iliac regional soft tissue infiltration blockade, Behavioral: Pain Score Survey, Behavioral: Pill Count, Drug: Bupivacaine, Drug: Liposomal BupivacaineBupivacaine plus liposomal bupivacaine fascial iliaca regional soft tissue infiltration blockade |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient is scheduled to undergo hip arthroscopy
- Patient is between 18-50 years of age
- DEERS eligibility
Key exclusion criteria (7 listed)
- Patients who are on a medication pre-operatively that would prohibit them from receiving one of the study medications
- 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)
- Patient has a history of previous hip arthroscopy surgery
- The patient is pregnant - ruled out with routine urine pregnancy test the morning of surgery in the anesthesia pre-operative unit.
- The patient carries a pre-existing diagnosis of a pain disorder. (Example: Fibromyalgia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascial iliac regional soft tissue infiltration blockadeFascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy) | Procedure or surgery | Bupivacaine plus liposomal bupivacaine, Bupivicaine |
| Pain Score SurveyUtilizing: Defense and Veterans Pain Rating Scale (DVPRS) | Behavioural | Bupivacaine plus liposomal bupivacaine, Bupivicaine |
| Pill CountPatient reported as needed (prn) pain medication usage | Behavioural | Bupivacaine plus liposomal bupivacaine, Bupivicaine |
| Bupivacaine | Drug | Bupivacaine plus liposomal bupivacaine, Bupivicaine |
| Liposomal Bupivacaine | Drug | Bupivacaine plus liposomal bupivacaine |
Primary outcome
Pain
Time frame: Immediate Post-operative
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.
1 secondary outcome
Opioid Use
Time frame: Immediate Post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Individual participant dataSharing planned: No. Individual participant data will be combined together for data analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Kent, MD study director
Walter Reed National Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fascial iliac regional soft tissue infiltration blockade, Pain Score Survey and Pill Count in people with Hip Pain Chronic and Anesthesia, run by Walter Reed National Military Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Immediate Post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.