Pain, PostoperativePhase 4NCT03844451
Enhanced Recovery With Liposomal Bupivacaine in Orthognathic Surgery
A Phase 4 study testing Liposomal Bupivacaine and Bupivacaine and Epinephrine in people with Pain, Postoperative, run by University of Texas at Austin at 1 site in United States.
Trial summary
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2… Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Liposomal Bupivacaine and Bupivacaine and Epinephrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2019to 1 Nov 2019
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.
Who cannot join
- Only those patients with insufficient data in their medical records or contraindications to the administration of liposomal bupivacaine (hepatic disease or allergy to amide local anesthetics) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dell Children's Medical Center
Austin, Texas, 78723
Kristopher Day, MD, 319-601-9283, kristophermday@gmail.com
About this study
Official title: ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).
Read the detailed description
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals.
- Conditions
- Pain, Postoperative
- Being tested
- Liposomal Bupivacaine, Bupivacaine and Epinephrine
- Keywords
- Exparel, liposomal bupivacaine, postoperative, pain control
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.
Bupivacaine and EpinephrineDrug
At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivicaine with nerve block | Experimental | The treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block. Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine and Epinephrine |
| Nerve block only | Placebo comparator | The control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block. Receives: Drug: Bupivacaine and Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization status post jaw surgery
The amount of time spent in the hospital after the surgery
Measured: Until discharge from hospital, an average of 3 days
Secondary outcomes (3)
Total morphine-equivalents
Amount of morphine-equivalents consumed by patient
Measured: First 48 hours after surgery
Pain Scores
On a 1-10 visual analogue scale, measured per nursing with vital signs
Measured: Until discharge from hospital, an average of 3 days
Oral intake
Oral intake measured in cc
Measured: First 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start17 May 2019 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
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.
- More trials run by University of Texas at AustinThe 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristopher Day, University of Texas at Austin
- Investigators
- Kristopher Day, MD, Principal investigator, Dell Children's Medical Center of Central Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844451
- Sponsor's protocol ID
- 2018-09-0046
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENHANCED RECOVERY AFTER ORTHOGNATHIC SURGERY USING LIPOSOMAL BUPIVACAINE: A RANDOMIZED CONTROL TRIAL
- ClinicalTrials.gov ID
- NCT03844451
- Acronym / sponsor ID
- 2018-09-0046
- Conditions
- Pain, Postoperative
- Keywords
- Exparel, liposomal bupivacaine, postoperative, pain control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 17 May 2019 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 18 Feb 2019 (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 proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30).
Detailed description
The proposed study design is a prospective, clinical trial comparing control group patients (CG; ncg = 30) that will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block to randomized treatment group patients that will receive an intraoperative V2 trigeminal nerve block using LB (TG; ntg = 30). The total study population size (N = 60) was determined by power analysis using a free online calculator for continuous variable comparison with two-sided equality. The hypotheses for this study is that a trigeminal nerve block LB-ERAS will confer better pain control to patients undergoing OGS compared to conventional bupivacaine and no ERAS protocol. We speculate that hospital stay, pain scores, duration to first postoperative oral intake, opioid pain medication requirements, and ORAE's will all be less in the TG than the CG. We postulate that the volume of oral nutrition tolerated in the first 48-hours postoperatively will be greater in the TG than the CG. Liposomal bupivacaine will be injected after a minimum of 20 minutes have passed since the pre-operative nerve block was administered. The patients' subjective pain experienced will be quantified by a traditional 10-point visual analogue score (VAS) in the post-anesthesia care unit (PACU), at time of admission to the post-operative recovery room, throughout the inpatient recovery period, and at time of discharge. The time to tolerance of first oral intake will be measured in hours. The amount of first-48-hour oral intake will be measured in milliliters (mL). We believe that a LB-ERAS protocol will result in lower necessary doses of opioid pain medications. This will be measured as first 48-hour total mg/kg dosage of opioid pain medication converted to oxycodone-equivalents by standard conversion ratios. The incidence of ORAE's will be tallied by the number of necessary prn doses of symptomatic management anti-pyretic and anti-nausea medications. We expect this to be lower in the TG. The degree of respiratory suppression will be measured by first 48-hour respiratory rate between CG and TG patients, which we expect to be lower in the CG relative to higher opioid pain medication totals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivicaine with nerve block | Experimental | Drug: Liposomal Bupivacaine, Drug: Bupivacaine and EpinephrineThe treatment group will receive an intraoperative V2 trigeminal nerve block using liposomal bupivacaine in addition to a standard bupivacaine nerve block. |
| Nerve block only | Placebo comparator | Drug: Bupivacaine and EpinephrineThe control group will undergo conventional perioperative management without an ERAS protocol and standard bupivacaine intraoperative nerve block. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All patients undergoing orthognathic surgery at Dell Children's Medical Center will be intended for inclusion in the study.
Key exclusion criteria (1 listed)
- Only those patients with insufficient data in their medical records or contraindications to the administration of liposomal bupivacaine (hepatic disease or allergy to amide local anesthetics) will be excluded from the study.
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 BupivacaineAt the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block. | Drug | Liposomal bupivicaine with nerve block |
| Bupivacaine and EpinephrineAt the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block. | Drug | Liposomal bupivicaine with nerve block, Nerve block only |
Primary outcome
Duration of hospitalization status post jaw surgery
Time frame: Until discharge from hospital, an average of 3 days
The amount of time spent in the hospital after the surgery
3 secondary outcomes
Total morphine-equivalents
Time frame: First 48 hours after surgery
Pain Scores
Time frame: Until discharge from hospital, an average of 3 days
Oral intake
Time frame: First 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- 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.
Kristopher Day, MD principal investigator
Dell Children's Medical Center of Central Texas
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 and Bupivacaine and Epinephrine in people with Pain, Postoperative, run by University of Texas at Austin 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 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: status not confirmed, as of the sponsor's last update on 18 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kristopher Day, MD (3196019283, kristophermday@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospitalization status post jaw surgery (time frame: Until discharge from hospital, an average of 3 days). 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 18 Feb 2019.