The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Bupivacaine/Epinephrine
- Conditions
- Pain Management
- Sponsor
- Washington University School of Medicine
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs).
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults age 18 and over
- •Isolated facial fracture to the mandible and/or midface undergoing surgical repair
- •No allergy to local anesthetic
- •Ability to read, write, and understand English
Exclusion Criteria
- •Patients under the age of 18
- •Isolated nasal bone fracture
- •Polytrauma (I.e. injury pattern resulting in hospital admission for multiple bony fractures outside of the face)
- •Allergy to local anesthetic
Arms & Interventions
Bupivacaine injection
The surgeon will be provided with a 10 mL syringe, and he/she will be blinded to the contents of the syringe. The appropriate landmarks will be identified, and a 21, 25, or 27- gauge needle will be used to perform the nerve block with 0.25% bupivacaine.
Intervention: Bupivacaine/Epinephrine
Saline injection
The placebo sham injection will be performed in an identical fashion as the nerve block with the exception of using 10 mL of 0.9% saline injection instead of bupivacaine.
Intervention: Saline
Outcomes
Primary Outcomes
Impact of a perioperative bupivacaine nerve block on PACU opioid use as assessed by the amount of opioids received in morphine milligram equivalents (MMEs).
Time Frame: 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 Outcomes
- 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)