PainPhase 4NCT02606448
Exparel Infiltration in Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing Liposomal bupivacaine, Femoral nerve block and Ropivacaine in people with Pain, run by Henry Ford Health System.
Trial summary
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Liposomal bupivacaine, Femoral nerve block and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Nov 2015
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients over the age of 16 scheduled for primary or revision anterior cruciate ligament reconstruction by one fellowship trained sports surgeon will be eligible for inclusion
Who cannot join
- Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL
About this study
Official title: Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible. The study compares pain control and opioid consumption in patients undergoing ACL reconstruction between patients receiving liposomal bupivacaine and those who underwent a preoperative femoral nerve block.
Read the detailed description
Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age sixteen and scheduled for primary or revision anterior cruciate ligament reconstruction (ACL) a single fellowship trained sports surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL.
Liposomal Bupivacaine has a refrigerated shelf life of one month in our facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned anterior cruciate ligament reconstruction in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy.
The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Femoral nerve block (FNB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative FNB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative FNB.
Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline after harvest of the hamstring graft or patella tendon graft. The solution will be applied to the wound bed, graft site, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the knee joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.
Patient in the FNB will receive postoperative ultrasound guided FNB. Experienced anesthesiologists will apply all FNBs in this study.
Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes.
Planned Data Analysis:
Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.
- Conditions
- Pain
- Being tested
- Liposomal bupivacaine, Femoral nerve block, Ropivacaine
- Keywords
- pain control, patient satisfaction, liposomal bupivacaine, Anterior cruciate ligament reconstruction
- Medical subject headings
- Pain, Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Local infiltration of liposomal bupivacaine
Femoral nerve blockProcedure or surgery
Pre-operative femoral nerve block
RopivacaineDrug
Ropivicaine was used in all femoral nerve blocks
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Active comparator | Patients in this group received preoperative ultrasound guided femoral nerve blocks by senior anesthesiologist using ropivicaine. Receives: Procedure: Femoral nerve block; Drug: Ropivacaine |
| Liposomal Bupivacaine | Experimental | Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels
Patients recorded pain lvls every four hours using VAS scales for four days post operatively
Measured: 4 days postoperatively
Secondary outcomes (1)
Morphine equivalents
Patients recorded opioid intake for four days postoperatively
Measured: 4 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606448
- Sponsor's protocol ID
- EXP-ACL
- Status last verified
- Dec 2023
- First submitted
- 5 Oct 2015
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine Versus Femoral Nerve Block for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02606448
- Acronym / sponsor ID
- EXP-ACL
- Conditions
- Pain
- Keywords
- pain control, patient satisfaction, liposomal bupivacaine, Anterior cruciate ligament reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Nov 2015 (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.
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over sixteen desiring anterior cruciate ligament reconstruction will be eligible. The study compares pain control and opioid consumption in patients undergoing ACL reconstruction between patients receiving liposomal bupivacaine and those who underwent a preoperative femoral nerve block.
Detailed description
Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All patients over age sixteen and scheduled for primary or revision anterior cruciate ligament reconstruction (ACL) a single fellowship trained sports surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL.
Liposomal Bupivacaine has a refrigerated shelf life of one month in our facility. Patients will be sequentially recruited into the randomization process. Liposomal Bupivacaine will be held by the Henry Ford hospital pharmacy up to one month prior to planned anterior cruciate ligament reconstruction in anticipation of surgery on eligible patients. The sterile solutions will be delivered to and kept by the inpatient clinical pharmacy until the date of surgery and delivered to the operating room at the beginning of a surgical case. The current dose of Liposomal Bupivacaine has been chosen based on previously published data of local infiltrative analgesia with Liposomal Bupivacaine and one published study on Liposomal Bupivacaine efficacy.
The week prior to surgery, patients will be randomized to receive Local infiltration anesthesia (LIA) with Liposomal Bupivacaine, or Femoral nerve block (FNB) using a computer generated sequence. The results of randomization will be securely delivered to the anesthesiologist and the surgeon the week prior. The anesthesiologist will view the assigned group to determine if a preoperative FNB will be given. Depending on the randomization group either an Liposomal Bupivacaine solution will be delivered to the operating room for local infiltration or the anesthesiologist will perform a preoperative FNB.
Patients in the Liposomal Bupivacaine group will receive LIA with 10cc(133mg) of Liposomal Bupivacaine solution dissolved in 20cc of sterile saline after harvest of the hamstring graft or patella tendon graft. The solution will be applied to the wound bed, graft site, and periosteum. The solution will be left unperturbed for five minutes. Thereafter the solution will be suctioned from the wound and the knee joint. Incisions will be closed in typical fashion and the wound dressed.The tourniquet will be deflated.
Patient in the FNB will receive postoperative ultrasound guided FNB. Experienced anesthesiologists will apply all FNBs in this study.
Following the procedure pain will be accessed subjectively through visual analog scale and numeric rating scale pain scores, pain diaries given to the patient to record at home, pain summary scores at follow up visits and objectively through narcotic pain requirement. A blind observer will also access outcomes.
Planned Data Analysis:
Means and standard deviations, as well as medians and interquartile ranges will be computed for pain scores.These outcomes will be compared by Wilcoxon rank sum tests. The amount of pain medication and pain scores will be compared by Wilcoxon rank sum tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Active comparator | Procedure: Femoral nerve block, Drug: RopivacainePatients in this group received preoperative ultrasound guided femoral nerve blocks by senior anesthesiologist using ropivicaine. |
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacainePatients in this group received local infiltration of Liposomal bupivacaine before the end of surgery. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 16 scheduled for primary or revision anterior cruciate ligament reconstruction by one fellowship trained sports surgeon will be eligible for inclusion
Key exclusion criteria (1 listed)
- Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy. Secondary exclusion criterion is an intact ACL
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: ExparelLocal infiltration of liposomal bupivacaine | Drug | Liposomal Bupivacaine |
| Femoral nerve blockPre-operative femoral nerve block | Procedure or surgery | Femoral Nerve Block |
| RopivacaineRopivicaine was used in all femoral nerve blocks | Drug | Femoral Nerve Block |
Primary outcome
Pain levels
Time frame: 4 days postoperatively
Patients recorded pain lvls every four hours using VAS scales for four days post operatively
1 secondary outcome
Morphine equivalents
Time frame: 4 days postoperatively
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 8 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine, Femoral nerve block and Ropivacaine in people with Pain, run by Henry Ford Health System.
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 1 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 levels (time frame: 4 days postoperatively). 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 8 Dec 2023.