The Effect of Opioid-Free Anesthesia in TMJ Surgery

Last updated: November 14, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

2

Condition

Oral Facial Pain

Treatment

Dexmedetomidine / Ketamine / Lidocaine

Clinical Study ID

NCT04724759
2020P003873
  • Ages 18-75
  • All Genders

Study Summary

This study aims is to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing oral and maxillofacial surgery (OMF) temporomandibular joint (TMJ) surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 to 75 (inclusive)

  • Scheduled for TMJ surgery (including both unilateral and bilateral procedures)

  • Planned arthroscopic surgical procedure

  • Preoperative plan to discharge the same day

Exclusion

Exclusion Criteria:

  • Inability to provide written informed consent

  • Pregnant patients

  • Open TMJ Surgeries

  • Planned overnight admission

  • Mental status disorder or patient who are unable to communicate

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Dexmedetomidine / Ketamine / Lidocaine
Phase: 2
Study Start date:
June 18, 2021
Estimated Completion Date:
April 23, 2023

Study Description

This study will enroll 60 patients undergoing TMJ surgery at Massachusetts General Hospital. Anesthetic care will be standardized according to current institutional standards of care. Intraoperative clinicians will not be blinded to group assignment. Patients will be randomized to one of two groups:

  • Group 1 - Opioid-free Anesthesia Patients: Patients who are not receiving opioids but the total intravenous anesthetic during surgery.

  • Group 2 - Standard Anesthesia Patients: Patients who undergo the standard of care and receive opioids as part of their anesthetic regimen.

Both groups employ strategies that are routinely used as part of standard clinical practice for TMJ surgery. Patients will otherwise receive the institutional standards of care for their surgical procedure and perioperative care.

Following intraoperative drug administration patients will be followed until discharge from the PACU to assess study endpoints while in the hospital. At the time of discharge from the PACU, members of the study team will ask the patient to compete a brief survey on their satisfaction with pain management.

Patients in this study will be anticipated to be discharged the same day as the surgical procedure. At the time of hospital or PACU discharge, the patient will be provided with a Medication Diary. This will be used to record pain medication administration in the first 48 hours after surgery, as well as any pain or complication they might experience at home.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

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