Post-operative PainPhase 4NCT02274870
Liposomal Bupivacaine for Post Operative Pain After Knee Replacement Surgery
A Phase 4 study testing Liposome Bupivacaine and Bupivacaine HCl in people with Post-operative Pain, run by Northwell Health at 1 site in United States.
Trial summary
Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Liposome Bupivacaine and Bupivacaine HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2017
- Phase
- Phase 4
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Status I-III
- Scheduled to undergo primary unilateral total knee arthroplasty
Who cannot join
- Patients who are pregnant or nursing
- Alcohol or narcotic dependence within the last 2 years
- Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
- BMI > 40kg/m2
- Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
- Allergies to amide-type local anesthetics
Show all 10Show fewer
- Any disease condition or lab result that could complicate a patients postoperative recovery
- History of hypotension
- Abnormal liver, renal or cardiac function
- Other physical, mental or medical conditions that, in the opinion of the investigator, make study participation inadvisable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery
Read the detailed description
This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.
266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.
It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.
- Conditions
- Post-operative Pain
- Being tested
- Liposome Bupivacaine, Bupivacaine HCl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposome BupivacaineDrug
Also called Bupivacaine Liposome, Injectable Suspension
Administered via local tissue infiltration around the knee joint
Bupivacaine HClDrug
Also called Standard of Care
Administered via CFNB
| Study group | Role | What they receive |
|---|---|---|
| Liposome Bupivacaine, | Experimental | Liposome Bupivacaine 266mg, Knee Infiltration Receives: Drug: Liposome Bupivacaine |
| Bupivacaine HCl | Active comparator | Bupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) Receives: Drug: Bupivacaine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity at Movement
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Measured: 24hrs
Secondary outcomes (9)
Pain Intensity at Rest
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale.
Higher values represent a higher pain intensity or worse outcome.
Measured: 24hrs
Opioid Consumption
Measured: 24hrs
Mean Plasma Bupivicaine Level
Measured: 72hrs
Mean Plasma Bupivacaine Levels
Measured: 48hrs
Mean Plasma Bupivacaine Level
Measured: 24hrs
Mean Plasma Bupivacaine Level
Measured: 12hrs
Mean Plasma Bupivacaine Level
Measured: 4hrs
Mean Plasma Bupivacaine Level
Measured: 2hrs
Mean Plasma Bupivacaine Level
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2016
- Study completionJan 2017
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 Post-operative PainStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Marino M.D., Northwell Health
- Investigators
- Joseph Marino, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274870
- Sponsor's protocol ID
- IRB: 14-237B
- Status last verified
- Jun 2018
- First submitted
- 22 Oct 2014
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine for Total Knee Arthroplasty Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT02274870
- Acronym / sponsor ID
- IRB: 14-237B
- Conditions
- Post-operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 24 Oct 2014 (estimated)
- Results
- Posted 14 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous femoral nerve blocks (CFNB) provide effective pain control to patients undergoing total knee replacement (TKR). However the resulting motor blockade can lead to decreased quadriceps muscle strength and delayed functional recovery.The purpose of this study is to compare the effect of Liposome Bupivacaine infiltration into the knee to CFNB on pain control and functional recovery
Detailed description
This is a prospective, randomized, active controlled study in patients undergoing total knee replacement. The objective of this study is to compare the efficacy of Liposome Bupivacaine, in managing postoperative pain, to standard of care CFNB. Following informed consent, patients will be randomized to one of two groups, Liposome Bupivacaine or active control, CFNB group.
266 mg Liposome Bupivacaine plus Bupivicaine HCL (150mg) will be administered via local joint infiltration around the knee joint prior to wound closure. In the control group a CFNB will be placed for 48hrs prior to surgery. Outcomes measured included pain at rest, movement and quadriceps muscle strength on the first and second postoperative day.
It is hypothesized that Liposome Bupivacaine will provide effective pain control and improved preservation of quadriceps muscle strength, in comparison to CFNB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposome Bupivacaine, | Experimental | Drug: Liposome BupivacaineLiposome Bupivacaine 266mg, Knee Infiltration |
| Bupivacaine HCl | Active comparator | Drug: Bupivacaine HClBupivacaine HCl Continuous Femoral Nerve Block (CFNB), bolus and continuous for 48 hrs) |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Status I-III
- Scheduled to undergo primary unilateral total knee arthroplasty
Key exclusion criteria (10 listed)
- Patients who are pregnant or nursing
- Alcohol or narcotic dependence within the last 2 years
- Condition requiring regular use of analgesia that may confound post surgical assessments as determined by principle investigator
- BMI > 40kg/m2
- Contraindication to acetaminophen, morphine, oxycodone, ketorolac, epinephrine, or pathological conditions potentially aggravated by epinephrine
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 |
|---|---|---|
| Liposome BupivacaineAlso: Bupivacaine Liposome, Injectable SuspensionAdministered via local tissue infiltration around the knee joint | Drug | Liposome Bupivacaine, |
| Bupivacaine HClAlso: Standard of CareAdministered via CFNB | Drug | Bupivacaine HCl |
Primary outcome
Pain Intensity at Movement
Time frame: 24hrs
Pain intensity at maximum knee flexion measured using a 0-10 visual analog scale. Higher values represent a higher pain intensity or worse outcome.
9 secondary outcomes
Pain Intensity at Rest
Time frame: 24hrs
Opioid Consumption
Time frame: 24hrs
Mean Plasma Bupivicaine Level
Time frame: 72hrs
Mean Plasma Bupivacaine Levels
Time frame: 48hrs
Mean Plasma Bupivacaine Level
Time frame: 24hrs
Mean Plasma Bupivacaine Level
Time frame: 12hrs
Mean Plasma Bupivacaine Level
Time frame: 4hrs
Mean Plasma Bupivacaine Level
Time frame: 2hrs
Mean Plasma Bupivacaine Level
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Joseph Marino, MD principal investigator
Northwell Health
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 Liposome Bupivacaine and Bupivacaine HCl in people with Post-operative Pain, run by Northwell Health 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 2 inclusion and 10 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 14 Jun 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?
Yes. Results are posted in the registry (first posted 14 Jun 2018). 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?
Pain Intensity at Movement (time frame: 24hrs). 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 14 Jun 2018.