The Effect of Opioid-Free Anesthesia in TMJ Surgery

Temporomandibular Joint Disorders Clinical Trial

Official title:

The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724759
• Other study ID #: 2020P003873
• Status: Recruiting
• Phase: Phase 2
• Start date: June 18, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2022
• Source: Massachusetts General Hospital
• Contact: Jingping Wang, MD
• Phone: (617) 643 - 2729
• Email: JWANG23[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Drug:
• Dexmedetomidine / Ketamine / Lidocaine
Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics, as needed clinically. This includes administration of 5 mcg/kg/min of ketamine plus 0.5 - 1.0 µg/kg/hr of dexmedetomidine (Precedex) as a continuous infusion, started from induction to stop one hour before surgery is anticipated to end.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	Pain will be measured using the eleven point (0 to 10) numeric rating scale. 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.	Through in-hospital study completion, an average of 1 day
Secondary	Perioperative Opioid Use	Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.	48 hours postoperatively
Secondary	Rescue Analgesia in the PACU	Use, dosage and time to use of rescue analgesia in the PACU will be reported.	Through in-hospital study completion, an average of 1 day
Secondary	Pain Satisfaction	Self-report pain satisfaction will be assessed at the time of PACU discharge using the Revised American Pain Society Patient Outcome Questionnaire.	Through in-hospital study completion, an average of 1 day
Secondary	Incidence of Opioid Related Adverse Effects	The incidence of ileus, nausea/vomiting, and pruritis will be reported.	48 hours postoperatively
Secondary	Length of Stay	Length of PACU and hospital stay will be reported.	Through in-hospital study completion, an average of 1 day
Secondary	Percocet Use	The total dose of Percocet used at 24 and 48 hours after surgery will be reported.	48 hours postoperatively