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Recruiting NCT06429501

Local Anesthesia for Facial Fractures

Phase II Interventional Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bupivacaine/Epinephrine, Saline.
Who it may be relevant to
Registry conditions: Pain Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Perioperative Nerve Block on Opioid Use After Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial

Overview

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

  • Drug Bupivacaine/Epinephrine
    injection
  • Drug Saline
    injection

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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. [Time frame: within 1 month post surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Washington University — St Louis

Publications

  • Hedegaard H, Minino AM, Spencer MR, Warner M. Drug Overdose Deaths in the United States, 1999-2020. NCHS Data Brief. 2021 Dec;(426):1-8. PMID 34978529
  • Abraham AJ, Rieckmann T, Gu Y, Lind BK. Inappropriate Opioid Prescribing in Oregon's Coordinated Care Organizations. J Addict Med. 2020 Jul/Aug;14(4):293-299. doi: 10.1097/ADM.0000000000000569. PMID 31609864
  • BJC Healthcare. Level I Trauma Center. Barnes-Jewish Hospital. https://www.barnesjewish.org/Medical-Services/Trauma-Acute-CareSurgery/Level-I-Trauma-Center
  • Lapidus JB, Santosa KB, Skolnick GB, Som A, Cho GJ, Waljee JF, AuBuchon JD, Patel KB. Opioid Prescribing and Use Patterns in Postsurgical Facial Trauma Patients. Plast Reconstr Surg. 2020 Mar;145(3):780-789. doi: 10.1097/PRS.0000000000006588. PMID 32097326
  • Perloff MD, Chung JS. Urgent care peripheral nerve blocks for refractory trigeminal neuralgia. Am J Emerg Med. 2018 Nov;36(11):2058-2060. doi: 10.1016/j.ajem.2018.08.019. Epub 2018 Aug 8. PMID 30119988
  • Staity G, Saadi RA, Pool C, Lighthall JG. The Safety Profile of Liposomal Bupivacaine Use in Septorhinoplasty. Facial Plast Surg Aesthet Med. 2022 May-Jun;24(3):202-206. doi: 10.1089/fpsam.2020.0544. Epub 2021 Feb 22. PMID 33617355
  • Schumacher JK, Cristel RT, Talugula S, Shah AR. The Use of Adjunctive Perioperative Nerve Blocks in Rhinoplasty in the Immediate Postoperative Period. Facial Plast Surg Aesthet Med. 2023 Jul-Aug;25(4):361-362. doi: 10.1089/fpsam.2022.0125. Epub 2022 Sep 14. No abstract available. PMID 36106969
  • The University of Iowa Otolaryngology Protocols. https://medicine.uiowa.edu/iowaprotocols/maximum-recommended-doses-andduration-local-anesthetics

Identifiers

NCT: NCT06429501 · 202401085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗