Pain, PostoperativeEarly Phase 1NCT06499181
Multimodal Orthognathic Study Comparing Use of Exparel With Standard of Care.
A Early Phase 1 study testing Liposomal bupivacaine, Bupivacain and Epinephrin in people with Pain, Postoperative, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
A prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life, versus traditional bupivicaine alone. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Liposomal bupivacaine, Bupivacain and Epinephrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 1 Jan 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years or older
- Scheduled for Maxillary Orthognathic Surgery
- American Society of Anesthesiologists classification 1,2,3
- Able to provide consent, adhere to study schedule, complete study journal
Who cannot join
- 1 History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
- 2 Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone
- 3 Significant drug allergy history
- 4 Positive result from urine drug screen at pre-op visit
- 5 Currently pregnant or nursing at time of study or within 1 month of drug administration
- 6 Severe renal or hepatic impairment, significant cardiovascular disease; migraines, frequent headaches
Show all 10Show fewer
- 7 Use of any of the following medication within 1 month of liposomal bupivacaine infiltration or if the medications are being given to control pain: Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin Nonadrenaline Reuptake Inhibitors (SNRIs), gabapentin, pregabalin, or duloxetine.
- 8 Current use of systemic glucocorticosteroids within 1 month of enrollment in the study.
- 9 No concurrent procedures with 2 weeks before or after orthognathic procedure
- 10 No more than 1 previous surgery for similar condition or diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Can Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery?
A prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life, versus traditional bupivicaine alone.
Read the detailed description
A prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life versus traditional bupivicaine alone. A total of 100 patients who would ordinarily undergo maxillary orthognathic procedures will be randomized into 2 groups. One group will receive 133mg of Exparel (must limit volume of product due to spaces involved and other studies in oral surgery have used 133mg) at the completion of the procedure while the control group receives 50 mg of bupivicaine at the completion of the procedure as is typical standard of care. The injections will be made in similar regions near the incision lines. No other differences will be made between the groups. Perioperative anesthesia will consist of non-opioid techniques, and patients will be monitored post-operatively during a 1 night hospital admission. Patients will complete an anonymous daily diary for 7 days. The diary will consist of information regarding pain scores, quality of life (nausea, swelling, oral function, etc) and medicines taken.
At one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous week's experience regarding the topics of the questionnaires.
- Conditions
- Pain, Postoperative
- Being tested
- Liposomal bupivacaine, Bupivacain, Epinephrin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
The primary objective is to examine differences in post-operative opioid consumption between the two groups.
BupivacainDrug
Also called Marcaine, Sensorcaine
Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.
EpinephrinDrug
Also called Adrenalin Chloride, Epipen
Control group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group Exparel | Experimental | The experimental arm will be injected with 133mg (10cc) of liposomal bupivacaine (Exparel) near to the incision site one time only at the completion of the procedure. Receives: Drug: Liposomal bupivacaine |
| Control Group Bupivacaine | Active comparator | The control arm will be injected with 10cc of 0.5% bupivacaine (50 mg) with 1:50,000 epinephrine near to the incision site one time only at the completion of the procedure per standard procedure. Receives: Drug: Bupivacain; Drug: Epinephrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.
The primary objective is to examine differences in post-operative opioid consumption between the two groups
Measured: Daily up to seven days post operative procedure.
Secondary outcomes (5)
Post-operative nausea and vomiting
Examine the number of times per day the participant experiences nausea and/or vomiting.
Measured: Daily up to seven days post operative procedure.
Post-operative sleeping quality.
The Epworth Sleepiness Scale will be used to ascertain the quality of sleep. Eight situations are presented with the participant choosing the following responses:
No chance of dozing = 0 Slight chance of dozing = 1 Moderate chance of dozing = 2 High chance of dozing = 3
The higher the combined score the poorer the quality of sleep.
Measured: Daily up to seven days post operative procedure.
Post operative quality of life.
Post operative quality of life was ascertained with the 10 point Likert scaled question, "What is your rating for your actual overall comfort?'. 1 = Very low overall comfort, 5 = Neither low or high overall comfort, 10 = Very high overall comfort.
The higher the score means a better outcome.
Measured: Daily up to seven days post operative procedure.
Post operative oral function.
Clinician will assess occlusion and midline symmetry on day of surgery post operative procedure and at one week post operative procedure clinic visit per standard of care with the aid of photographs using a millimeter ruler.
Measured: Day of surgery and at seventh day post operative procedure.
Post operative swelling.
Photos comparing cheek and lower jaw swelling with a millimeter ruler taken on day of surgery post operative procedure and one week post operative procedure clinic visit will be made by clinician per standard of care.
Measured: Day of surgery and on post operative procedure day seven.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start28 Feb 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The control arm will be injected with 10cc of 0.5% bupivacaine with 1:50,000 epinephrine. The study arm will be injected with 133mg (10cc) of liposomal bupivacaine.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Patrick Morrell, United States Naval Medical Center, San Diego
- Investigators
- Patrick T Morrell, DMD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499181
- Sponsor's protocol ID
- NMCSD.2017.0067
- Status last verified
- Jul 2024
- First submitted
- 4 Jun 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Using Exparel Decrease the Post Operative Use of Narcotics in Maxillary Orthognathic Surgery?
- ClinicalTrials.gov ID
- NCT06499181
- Acronym / sponsor ID
- NMCSD.2017.0067
- Conditions
- Pain, Postoperative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 12 Jul 2024 (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.
A prospective, randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life, versus traditional bupivicaine alone.
Detailed description
A prospective randomized clinical trial to determine if using liposomal bupivicaine in maxillary orthognathic procedures can reduce the post-operative use of opioids as well as improving the patient's quality of life versus traditional bupivicaine alone. A total of 100 patients who would ordinarily undergo maxillary orthognathic procedures will be randomized into 2 groups. One group will receive 133mg of Exparel (must limit volume of product due to spaces involved and other studies in oral surgery have used 133mg) at the completion of the procedure while the control group receives 50 mg of bupivicaine at the completion of the procedure as is typical standard of care. The injections will be made in similar regions near the incision lines. No other differences will be made between the groups. Perioperative anesthesia will consist of non-opioid techniques, and patients will be monitored post-operatively during a 1 night hospital admission. Patients will complete an anonymous daily diary for 7 days. The diary will consist of information regarding pain scores, quality of life (nausea, swelling, oral function, etc) and medicines taken.
At one week post op the participant will return to the clinic where they will fill out a final questionnaire discussing the previous week's experience regarding the topics of the questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The control arm will be injected with 10cc of 0.5% bupivacaine with 1:50,000 epinephrine. The study arm will be injected with 133mg (10cc) of liposomal bupivacaine.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group Exparel | Experimental | Drug: Liposomal bupivacaineThe experimental arm will be injected with 133mg (10cc) of liposomal bupivacaine (Exparel) near to the incision site one time only at the completion of the procedure. |
| Control Group Bupivacaine | Active comparator | Drug: Bupivacain, Drug: EpinephrinThe control arm will be injected with 10cc of 0.5% bupivacaine (50 mg) with 1:50,000 epinephrine near to the incision site one time only at the completion of the procedure per standard procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 years or older
- Scheduled for Maxillary Orthognathic Surgery
- American Society of Anesthesiologists classification 1,2,3
- Able to provide consent, adhere to study schedule, complete study journal
Key exclusion criteria (10 listed)
- 1 History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
- 2 Contraindication to lidocaine, epinephrine, bupivacaine, or oxycodone
- 3 Significant drug allergy history
- 4 Positive result from urine drug screen at pre-op visit
- 5 Currently pregnant or nursing at time of study or within 1 month of drug administration
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: ExparelThe primary objective is to examine differences in post-operative opioid consumption between the two groups. | Drug | Experimental Group Exparel |
| BupivacainAlso: Marcaine, SensorcaineControl group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care. | Drug | Control Group Bupivacaine |
| EpinephrinAlso: Adrenalin Chloride, EpipenControl group to receive 10cc of 0.5% bupivacaine with 1:50,000 epinephrine at the completion of the procedure per typical standard of care. | Drug | Control Group Bupivacaine |
Primary outcome
Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures.
Time frame: Daily up to seven days post operative procedure.
The primary objective is to examine differences in post-operative opioid consumption between the two groups
5 secondary outcomes
Post-operative nausea and vomiting
Time frame: Daily up to seven days post operative procedure.
Post-operative sleeping quality.
Time frame: Daily up to seven days post operative procedure.
Post operative quality of life.
Time frame: Daily up to seven days post operative procedure.
Post operative oral function.
Time frame: Day of surgery and at seventh day post operative procedure.
Post operative swelling.
Time frame: Day of surgery and on post operative procedure day seven.
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 19 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Patrick T Morrell, DMD principal investigator
United States Naval Medical Center, San Diego
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 Liposomal bupivacaine, Bupivacain and Epinephrin in people with Pain, Postoperative, run by United States Naval Medical Center, San Diego 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 4 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 19 Jul 2024. 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 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?
Differences in post-op opioid consumption between local Exparel infiltration and bupivacaine in maxillary orthognathic procedures. (time frame: Daily up to seven days post operative procedure.). 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 19 Jul 2024.