Pain Management
Conditions
Keywords
otolaryngology, surgery, facial plastic, trauma
Brief summary
The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative facial fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence.
Detailed description
Effective pain management is critical to successful postoperative care and is known to decrease patient morbidity, incurred patient and hospital costs, and length of hospital stay. Pain and nausea after surgery for traumatic facial fractures can limit patients' early morbidity, oral intake, and ability to communicate. The study is a double-blind randomized, placebo controlled trial examining the impact of perioperative bupivacaine nerve block on PACU recovery metrics. Patients with operative mandibular or midface fractures are randomized to receive either bupivacaine or saline injections prior to the anesthesia emergence. The primary outcome measure is the amount of opioid that patients receive in PACU in morphine milligram equivalent (MMEs). The purpose of the study is to define whether a perioperative bupivacaine nerve block results in a decrease in the amounts of opioids and antiemetics that patients receive in PACU after CMF trauma surgery.
Interventions
DRUGBupivacaine/Epinephrine
injection
DRUGSaline
injection
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All study team members and the participants will be blinded to the assignment of participants in the study groups. Only the pharmacist will prepare the study syringes and the unblinded statistician will have access to the study group assignments.
Intervention model description
Double-blinded, placebo-controlled randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults age 18 and over 2. Isolated facial fracture to the mandible and/or midface undergoing surgical repair 3. No allergy to local anesthetic 4. Ability to read, write, and understand English
Exclusion criteria
1. Patients under the age of 18 2. Isolated nasal bone fracture 3. Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face) 4. Allergy to local anesthetic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs). | day 1 or the day of surgery | To evaluate the impact of a perioperative bupivacaine nerve block on PACU opioid use in patients undergoing operative fixation of facial fractures compared to placebo nerve block assessment of the amount of opioids that patients receive in PACU in morphine milligram equivalents (MMEs) will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of a perioperative bupivacaine nerve block on antiemetic use as assessed by the numbers who receive opioids and antiemetics, amount of antiemetics, pain score, frequency of emesis, and time until discharge. | within 1 month post surgery | To evaluate the impact of a perioperative bupivacaine nerve block on PACU antiemetic use in patients undergoing operative fixation of facial fractures compared to placebo nerve block. Additional variables that will be collected perioperatively include the medications used for induction/maintenance of anesthesia as well as intraoperative analgesia (I.e. fentanyl, hydromorphone, morphine, acetaminophen, ketorolac, etc.), operative time, estimated blood loss, and intraoperative complications. |
Countries
United States
Contacts
CONTACTAmrita Hari-Raj, MD
CONTACTSara Kukuljan
PRINCIPAL_INVESTIGATORAmrita Hari_Raj, MD
Washington University School of Medicine
STUDY_DIRECTORJay Piccirillo, MD
Washington University School of Medicine
Outcome results
None listed