Clinical trial NCT04724759: The Effect of Opioid-Free Anesthesia in TMJ Surgery
Official title: The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Keywords: Opioid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: Through in-hospital study completion, an average of 1 day
Secondary outcomes:
measure: Perioperative Opioid Use
timeFrame: 48 hours postoperatively
measure: Rescue Analgesia in the PACU
timeFrame: Through in-hospital study completion, an average of 1 day
measure: Pain Satisfaction
timeFrame: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours
measure: Incidence of Opioid Related Adverse Effects
timeFrame: 48 hours postoperatively
measure: Length of Stay (PACU Discharge)
timeFrame: Through in-hospital study completion, an average of 1 day
measure: Percocet Use
timeFrame: 48 hours postoperatively
measure: Length of Stay (Hospital Discharge)
timeFrame: Through in-hospital study completion, an average of 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jingping Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: