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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Kristopher Day, MD contact

3196019283

kristophermday@gmail.com

Raymond Harshbarger, MD contact

(512) 324-0644

RJHarshbarger@ascension.org

United States1 site, 1 recruiting
  • Dell Children's Medical Center

    Austin, Texas, 78723

    Kristopher Day, MD, 319-601-9283, kristophermday@gmail.com

    Recruiting

Other trials in United States

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.

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 groups in NCT03844451
Study groupRoleWhat they receive
Liposomal bupivicaine with nerve blockExperimentalThe 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 onlyPlacebo comparatorThe 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.

  1. 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)
  1. Total morphine-equivalents

    Amount of morphine-equivalents consumed by patient

    Measured: First 48 hours after surgery

  2. 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

  3. 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.

  1. First posted18 Feb 2019
  2. Study start17 May 2019 (estimated)
  3. Primary completion1 Sep 2019 (estimated)
  4. Study completion1 Nov 2019 (estimated)

Resources

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)
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

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.

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