AmputationPhase 4NCT04360421
Use of Long-acting Bupivacaine In Lower Extremity Amputation
A Phase 4 study testing Liposomal bupivacaine in people with Amputation and Anesthesia, Local, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Anesthesia, Local, Opioid Use
- What is being tested?
- Liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2020to 1 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients who underwent unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral [1 year retrospective analysis]
- Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral
Who cannot join
- Minor amputations
- Liver dysfunction (impaired metabolism of Amides)
- Concomitant psychiatric or chronic pain disorders
- Pregnancy
- Amide anesthetic allergy
- Presence of perioperative sepsis or acute organ dysfunction
Show all 9Show fewer
- Need for ICU admission at any point
- Polytrauma
- Quadriplegic/Paraplegic/Insensate
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Medical Center
Loma Linda, California, 92354
About this study
Official title: Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation
The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.
- Conditions
- Amputation, Anesthesia, Local, Opioid Use
- Being tested
- Liposomal bupivacaine
- Keywords
- lower extremity amputation, liposomal bupivacaine, expedited recovery, vascular surgery, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Patient's undergoing major extremity amputation and enrolled in the study as part of the experimental arm will, during their amputation operation, receive liposomal bupivicaine per recommended manufacturing dosing and administration in a "field block" for long-acting local anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative liposomal bupivacaine field block | Experimental | Patients will receive the maximum dosage of liposomal bupivacaine allowed for their body weight or the full vial, whichever is less. Injected once, along the incision before closure of the skin. Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid use
Total morphine equivalent
Measured: Up to 4 weeks
Total cost of stay
US Dollar cost
Measured: Up to 4 weeks
Secondary outcomes (1)
Pain scores
Numeric rating scale of 0 to 10, where 0 is no pain and 10 is the worst possible pain.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start21 Apr 2020
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristyn Mannoia, MD, Principal investigator, Loma Linda University Department of Vascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360421
- Sponsor's protocol ID
- 5200004
- Status last verified
- Aug 2023
- First submitted
- 20 Apr 2020
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Motakef S, Wong WW, Ingargiola MJ, Nguyen D, Galdyn IA, Kim HY, Gupta SC. Liposomal Bupivacaine in Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Nov 20;5(11):e1559. doi: 10.1097/GOX.0000000000001559. eCollection 2017 Nov.
PubMed 29263963Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
PubMed 25282071Hyland SJ, Deliberato DG, Fada RA, Romanelli MJ, Collins CL, Wasielewski RC. Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):488-494. doi: 10.1016/j.arth.2018.11.026. Epub 2018 Nov 23.
PubMed 30554925Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.
PubMed 30192328Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
PubMed 22900785
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Liposomal Bupivacaine (Exparel) In Expedited Recovery Following Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT04360421
- Acronym / sponsor ID
- 5200004
- Conditions
- Amputation, Anesthesia, Local, Opioid Use
- Keywords
- lower extremity amputation, liposomal bupivacaine, expedited recovery, vascular surgery, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- 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.
The purpose of this investigator-initiated study is to assess the use of liposomal bupivacaine in major extremity amputation and its effects on post-operative opioid narcotic use, length of stay, and in-hospital costs. Liposomal bupivacaine is an encapsulated, injectable amide anesthetic intended for use in long-acting local anesthesia. It has been shown in randomized trials to be effective in reducing post-operative pain while reducing opioid narcotic use and length of hospital stay following several surgical procedures, particularly after total knee arthroplasty. Extremity amputation is a painful operation often performed in seriously ill or debilitated patients, often related to infection, trauma or malignancy. Application of liposomal bupivacaine in extremity amputation is not well described. The investigators intend to enroll adults greater than age 18 years of age who are to undergo major extremity amputation. Patients will receive targeted injections of liposomal bupivacaine during their procedure. Patient pain scores, total opioid use, and length of hospital stay will be tracked. Patients receiving liposomal bupivicaine will be compared to similarly matched subjects who received standard anesthesia regimens without liposomal bupivicaine. The investigators hypothesize that liposomal bupivicaine used during major amputation decreases opioid use, hospital stay, and in-hospital costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative liposomal bupivacaine field block | Experimental | Drug: Liposomal bupivacainePatients will receive the maximum dosage of liposomal bupivacaine allowed for their body weight or the full vial, whichever is less. Injected once, along the incision before closure of the skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients who underwent unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral [1 year retrospective analysis]
- Patients who meet clinical indication for unilateral or bilateral lower extremity major amputation, either primary or revision: partial foot, ankle disarticulation, transtibial, knee disarticulation, transfemoral
Key exclusion criteria (9 listed)
- Minor amputations
- Liver dysfunction (impaired metabolism of Amides)
- Concomitant psychiatric or chronic pain disorders
- Pregnancy
- Amide anesthetic allergy
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 bupivacainePatient's undergoing major extremity amputation and enrolled in the study as part of the experimental arm will, during their amputation operation, receive liposomal bupivicaine per recommended manufacturing dosing and administration in a "field block" for long-acting local anesthesia. | Drug | Intraoperative liposomal bupivacaine field block |
Primary outcome
Total opioid use
Time frame: Up to 4 weeks
Total morphine equivalent
Total cost of stay
Time frame: Up to 4 weeks
US Dollar cost
1 secondary outcome
Pain scores
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 29263963Motakef S, Wong WW, Ingargiola MJ, Nguyen D, Galdyn IA, Kim HY, Gupta SC. Liposomal Bupivacaine in Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Nov 20;5(11):e1559. doi: 10.1097/GOX.0000000000001559. eCollection 2017 Nov.
- Background: PubMed 25282071Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
- Background: PubMed 30554925Hyland SJ, Deliberato DG, Fada RA, Romanelli MJ, Collins CL, Wasielewski RC. Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. J Arthroplasty. 2019 Mar;34(3):488-494. doi: 10.1016/j.arth.2018.11.026. Epub 2018 Nov 23.
- Background: PubMed 30192328Felling DR, Jackson MW, Ferraro J, Battaglia MA, Albright JJ, Wu J, Genord CK, Brockhaus KK, Bhave RA, McClure AM, Shanker BA, Cleary RK. Liposomal Bupivacaine Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colon and Rectal Surgery Enhanced Recovery Pathway: A Randomized Clinical Trial. Dis Colon Rectum. 2018 Oct;61(10):1196-1204. doi: 10.1097/DCR.0000000000001211.
- Background: PubMed 22900785Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.
- Individual participant dataSharing planned: No
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
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.
Kristyn Mannoia, MD principal investigator
Loma Linda University Department of Vascular Surgery
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 Liposomal bupivacaine in people with Amputation and Anesthesia, Local, run by Loma Linda University 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 9 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 22 Aug 2023. 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 was stopped early (reason given: PI left institution). Results are not available in the source record.
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?
Total opioid use (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04360421, which also lists 5 linked publications.
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 22 Aug 2023.