Hip InjuriesNCT01907191
Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy
A study testing liposomal bupivacaine and Bupivacaine in people with Hip Injuries, run by Trinity Health Of New England at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Injuries
- What is being tested?
- liposomal bupivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having hip arthroscopy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: 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
Read the 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.
- Conditions
- Hip Injuries
- Being tested
- liposomal bupivacaine, Bupivacaine
- Keywords
- Hip Arthroscopy, Liposomal Bupivacaine, Bupivacaine
- Medical subject headings
- Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal bupivacaineDrug
Also called Exparel
(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy
BupivacaineDrug
Also called Marcaine
(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine | Experimental | Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy Receives: Drug: liposomal bupivacaine |
| Bupivacaine | Active comparator | Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)
Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 \& 3.
Measured: Post Operative Day 1, 2 & 3
Secondary outcomes (1)
Pain Scores
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)
Measured: Post Operative Day 1, 2 & 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip InjuriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, MD, Principal investigator, Saint Francis Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907191
- Sponsor's protocol ID
- 13-06-001
- Status last verified
- Aug 2022
- First submitted
- 28 Jun 2013
- Last updated
- 16 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bupivacaine to Liposomal Bupivacaine for Ultrasound Guided Periarticular Hip Infiltration for Postoperative Analgesia After Hip Arthroscopy.
- ClinicalTrials.gov ID
- NCT01907191
- Acronym / sponsor ID
- 13-06-001
- Conditions
- Hip Injuries
- Keywords
- Hip Arthroscopy, Liposomal Bupivacaine, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 19 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine | Experimental | Drug: liposomal bupivacaineUltrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy |
| Bupivacaine | Active comparator | Drug: BupivacaineBupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having hip arthroscopy
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| liposomal bupivacaineAlso: Exparel(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy | Drug | Liposomal bupivacaine |
| BupivacaineAlso: Marcaine(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy | Drug | Bupivacaine |
Primary outcome
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.
1 secondary outcome
Pain Scores
Time frame: Post Operative Day 1, 2 & 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sanjay Sinha, MD principal investigator
Saint Francis Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liposomal bupivacaine and Bupivacaine in people with Hip Injuries, run by Trinity Health Of New England 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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 16 Aug 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed) (time frame: Post Operative Day 1, 2 & 3). 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 16 Aug 2022.