The Effect of Opioid-Free Anesthesia in TMJ Surgery

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Temporomandibular Joint Disorders

Treatments: Drug: Dexmedetomidine / Ketamine / Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04724759

2020P003873

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Opioid-free Anesthesia

Experimental group

Description:

Patients in this arm will not receiving opioids but the total intravenous anesthetic during surgery. Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics.

Treatment:

Drug: Dexmedetomidine / Ketamine / Lidocaine

Standard Anesthesia

No Intervention group

Description:

Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.