The Effect of Opioid-Free Anesthesia in TMJ Surgery

Phase 2

Completed

Conditions: Temporomandibular Joint Disorders

Interventions: Drug: Dexmedetomidine / Ketamine / Lidocaine

Registration Number: NCT04724759

Lead Sponsor: Massachusetts General Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-free Anesthesia	Dexmedetomidine / Ketamine / Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Pain Score	Through in-hospital study completion, an average of 1 day	Pain will be measured using the eleven point (0 to 10) numeric rating scale with higher values representing a worse outcome. Pain scores will be recorded every 15 minutes until discharge from the post-anesthesia care unit (PACU) and at 12 and 24 hours postoperatively. Clinically documented pain scores will be recorded. Our primary outcome will be the worst documented pain score while in the PACU. Additional pain score time points will be evaluated as secondary endpoints.

Secondary Outcome Measures

Name	Time	Method
Percocet Use	48 hours postoperatively	The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Length of Stay (Hospital Discharge)	Through in-hospital study completion, an average of 1 day	Time to Hospital Discharge will be reported.
Perioperative Opioid Use	48 hours postoperatively	Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Rescue Analgesia in the PACU	Through in-hospital study completion, an average of 1 day	Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Pain Satisfaction	Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours	Self-report pain satisfaction will be assessed at the time of PACU discharge using the Revised American Pain Society Patient Outcome Questionnaire. This survey asked patients to grade pain either the pain experienced (graded from a 0-10 scale, 0 bring no pain and 10 being the worst pain possible), pain associated with certain movements (0-10 scale, 0 does not interfere and 10 being completely interferes), pain associated with emotions (0-10 scale, 0 not at all and 10 being extremely), side effects (0-10 scale, 0 none and 10 Severe), pain relief (0-10 scale, 0 no relief and 10 being complete relief), and satisfaction (0-10 scale, 0 extremely dissatisfied and 10 being extremely satisfied).
Incidence of Opioid Related Adverse Effects	48 hours postoperatively	The incidence of ileus, nausea/vomiting, and pruritis will be reported.
Length of Stay (PACU Discharge)	Through in-hospital study completion, an average of 1 day	Length of PACU and hospital stay will be reported.