BurnsEarly Phase 1NCT03705637
Liposomal Bupivicaine for Skin Graft Donor Sites in Burn Patients
A Early Phase 1 study testing Exparel in people with Burns and Postoperative Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Postoperative Pain
- What is being tested?
- Exparel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 24 Mar 2020
- Phase
- Early Phase 1
- 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
- Burn size ≤15% TBSA
- Anticipated one trip to operating room for single stage excision and grafting
- Total donor site surface area <500cm2
- Opioid naïve prior to admission for treatment of burn
- Patient able to consent
- 18 years or older
Who cannot join
- Medical Exclusions:
- Cardiac arrhythmias
- Heart block
- Pregnancy
- Breast-feeding mothers who will be unable to stop breastfeeding for 8 days post-injection
- Allergy to bupvicaine
Show all 14Show fewer
- Bradycardia
- Severe liver disease
- Incapacity to consent themselves
- Unlikely to survive burn Burn related exclusions
- Current substance abuse
- On opioids prior to admission
- Burn larger than 15% TBSA
- Prior autografting for this particular burn
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Liposomal Bipivicaine in Split Thickness Skin Graft Donor Sites in Burn Patients
Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to minimize that pain with local anesthetic as well as a combination of pain medications, the donor site pain lasts for days and is what patients often report as being the most painful part of their burn care.
There has been the development of a new form of local anesthesia that can last up to 72 hours when injected into tissue. Based on encouraging results in the literature in areas outside of burns, this study aims to evaluate whether administration of this medication at the time of surgery can help improve pain for burn patients in the postoperative period.
Read the detailed description
Patients suffer from pain resulting from the injury, wound care, and surgical treatment of their burns. As a result, they often require considerable amounts of narcotics. Given the concern for opiate addiction and the national opiate crisis the investigators have tried to explore other non-opiate means of pain control. One of the newest methods for pain relief is with liposomal bupivacaine, which can provide local analgesia for up to 72 hours at the site of injection. This medication has been used with good effect in multiple contexts.
Skin graft donor sites are the most painful portion of their surgical treatment and the pain typically is most severe during the first few days after surgery. For this reason, the investigators believe the addition of Exparel to the donor site will help with improved multi-modal pain control, making patients more comfortable. It also may decrease opiate requirements which would be beneficial for burn patients.
Few previous studies have been conducted using Exparel at the donor sites of skin grafted burn patients. One case series compares usage of Exparel from two different institutions, however the sample size at each was relatively small (n=20, 5, respectively). Their findings suggest that Exparel may be an effective way of managing postsurgical donor site pain. Based on these limited data there is a need for more robust studies, which is the motivation for doing this larger evaluation of patients.
The investigators believe that the use of Exparel can decrease pain for patients after surgery, in particular at their skin graft donor sites. The investigators want to conduct this study to evaluate whether Exparel can improve pain control for their patients and decrease their need for opiate narcotics.
- Conditions
- Burns, Postoperative Pain
- Being tested
- Exparel
- Medical subject headings
- Burns, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
- Donor sites will receive up to 50mg of 0.25marcaine with epinephrine injected uniformly into the wound.
- The donor site will also receive one bottle (266mg) of Exparel, diluted to be administered uniformly into the entire donor site, spaced out ever 3-4cm. The dilution will be as follows:
- 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
- Injection of local anesthesia will be performed after the donor site has been harvested and is hemostatic. The goal is to provide the maximum time possible for the local anesthetic to work while under anesthesia, so it can benefit the patient and not be administered at the end of the case just prior to extubation.
| Study group | Role | What they receive |
|---|---|---|
| Exparel Arm | Experimental | 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site. Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine milligram equivalents (MME) administered after receiving Exparel
Hypothesis: Subjects that receive Exparel will require fewer opioids to control their pain post-operatively (compared to historical controls).
Measured: 3 weeks after hospital discharge
Secondary outcomes (1)
Length of hospital stay
Hypothesis: Subjects who receive Exparel will be ready or discharge sooner than historical controls due to improved pain control
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 posted15 Oct 2018
- Study start1 Jun 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Friedstat, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705637
- Sponsor's protocol ID
- MGH2018P001992
- Status last verified
- Feb 2023
- First submitted
- 29 Sep 2018
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers outside of those directly involved in this study.
Publications
Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.
PubMed 25912739Mehran RJ, Martin LW, Baker CM, Mena GE, Rice DC. Pain Management in an Enhanced Recovery Pathway After Thoracic Surgical Procedures. Ann Thorac Surg. 2016 Dec;102(6):e595-e596. doi: 10.1016/j.athoracsur.2016.05.050.
PubMed 27847094Dissanaike S, McCauley J, Alphonso C. Liposomal bupivacaine for the management of postsurgical donor site pain in patients with burn injuries: a case series from two institutions. Clin Case Rep. 2017 Dec 5;6(1):129-135. doi: 10.1002/ccr3.1292. eCollection 2018 Jan.
PubMed 29375852Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011 Sep;89(9):46-52, 54, 56-61 passim.
PubMed 21939127
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liposomal Bipivicaine in Split Thickness Skin Graft Donor Sites in Burn Patients
- ClinicalTrials.gov ID
- NCT03705637
- Acronym / sponsor ID
- MGH2018P001992
- Conditions
- Burns, Postoperative Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 15 Oct 2018 (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.
Burn injuries are painful to patients and the sources of pain result from many areas including: the injury itself, wound care, and surgery. Inpatients that require surgical skin grafting is often required and the donor site of a skin graft is quite painful for patients. The investigators try to minimize that pain with local anesthetic as well as a combination of pain medications, the donor site pain lasts for days and is what patients often report as being the most painful part of their burn care.
There has been the development of a new form of local anesthesia that can last up to 72 hours when injected into tissue. Based on encouraging results in the literature in areas outside of burns, this study aims to evaluate whether administration of this medication at the time of surgery can help improve pain for burn patients in the postoperative period.
Detailed description
Patients suffer from pain resulting from the injury, wound care, and surgical treatment of their burns. As a result, they often require considerable amounts of narcotics. Given the concern for opiate addiction and the national opiate crisis the investigators have tried to explore other non-opiate means of pain control. One of the newest methods for pain relief is with liposomal bupivacaine, which can provide local analgesia for up to 72 hours at the site of injection. This medication has been used with good effect in multiple contexts.
Skin graft donor sites are the most painful portion of their surgical treatment and the pain typically is most severe during the first few days after surgery. For this reason, the investigators believe the addition of Exparel to the donor site will help with improved multi-modal pain control, making patients more comfortable. It also may decrease opiate requirements which would be beneficial for burn patients.
Few previous studies have been conducted using Exparel at the donor sites of skin grafted burn patients. One case series compares usage of Exparel from two different institutions, however the sample size at each was relatively small (n=20, 5, respectively). Their findings suggest that Exparel may be an effective way of managing postsurgical donor site pain. Based on these limited data there is a need for more robust studies, which is the motivation for doing this larger evaluation of patients.
The investigators believe that the use of Exparel can decrease pain for patients after surgery, in particular at their skin graft donor sites. The investigators want to conduct this study to evaluate whether Exparel can improve pain control for their patients and decrease their need for opiate narcotics.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exparel Arm | Experimental | Drug: Exparel20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Burn size ≤15% TBSA
- Anticipated one trip to operating room for single stage excision and grafting
- Total donor site surface area <500cm2
- Opioid naïve prior to admission for treatment of burn
- Patient able to consent
Key exclusion criteria (14 listed)
- Cardiac arrhythmias
- Heart block
- Pregnancy
- Breast-feeding mothers who will be unable to stop breastfeeding for 8 days post-injection
- Allergy to bupvicaine
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 |
|---|---|---|
| Exparel* Donor sites will receive up to 50mg of 0.25marcaine with epinephrine injected uniformly into the wound. * The donor site will also receive one bottle (266mg) of Exparel, diluted to be administered uniformly into the entire donor site, spaced out ever 3-4cm. The dilution will be as follows: o 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site. * Injection of local anesthesia will be performed after the donor site has been harvested and is hemostatic. The goal is to provide the maximum time possible for the local anesthetic to work while under anesthesia, so it can benefit the patient and not be administered at the end of the case just prior to extubation. | Drug | Exparel Arm |
Primary outcome
Morphine milligram equivalents (MME) administered after receiving Exparel
Time frame: 3 weeks after hospital discharge
Hypothesis: Subjects that receive Exparel will require fewer opioids to control their pain post-operatively (compared to historical controls).
1 secondary outcome
Length of hospital stay
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Background: PubMed 25912739Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.
- Background: PubMed 27847094Mehran RJ, Martin LW, Baker CM, Mena GE, Rice DC. Pain Management in an Enhanced Recovery Pathway After Thoracic Surgical Procedures. Ann Thorac Surg. 2016 Dec;102(6):e595-e596. doi: 10.1016/j.athoracsur.2016.05.050.
- Background: PubMed 29375852Dissanaike S, McCauley J, Alphonso C. Liposomal bupivacaine for the management of postsurgical donor site pain in patients with burn injuries: a case series from two institutions. Clin Case Rep. 2017 Dec 5;6(1):129-135. doi: 10.1002/ccr3.1292. eCollection 2018 Jan.
- Background: PubMed 21939127Kaplan RS, Porter ME. How to solve the cost crisis in health care. Harv Bus Rev. 2011 Sep;89(9):46-52, 54, 56-61 passim.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers outside of those directly involved in this study.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Exparel in people with Burns and Postoperative Pain, run by Massachusetts General Hospital 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 6 inclusion and 14 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 2 Mar 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Patient population too low to reasonably continue study, pandemic had started at time of cessation, further leading to study discontinuation.). 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?
Morphine milligram equivalents (MME) administered after receiving Exparel (time frame: 3 weeks after hospital discharge). 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 NCT03705637, which also lists 4 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 2 Mar 2023.