The Effect of Opioid-Free Anesthesia in TMJ Surgery

NCT04724759 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2020P003873
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Opioid

Outcome Measures

Primary Outcomes (1)

• Pain Score

  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.

  Through in-hospital study completion, an average of 1 day

Secondary Outcomes (7)

• Perioperative Opioid Use

  48 hours postoperatively

• Rescue Analgesia in the PACU

  Through in-hospital study completion, an average of 1 day

• Pain Satisfaction

  Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours

• Incidence of Opioid Related Adverse Effects

  48 hours postoperatively

• Length of Stay (PACU Discharge)

  Through in-hospital study completion, an average of 1 day

Study Arms (2)

Opioid-free Anesthesia

EXPERIMENTAL

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.

Drug: Dexmedetomidine / Ketamine / Lidocaine

Standard Anesthesia

NO INTERVENTION

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

Interventions

Dexmedetomidine / Ketamine / Lidocaine DRUG

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.

Also known as: Precedex

Opioid-free Anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide written informed consent
• Pregnant patients
• Open TMJ Surgeries
• Planned overnight admission
• Mental status disorder or patient who are unable to communicate

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Dexmedetomidine; Ketamine; Lidocaine

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Jingping Wang - Principal Investigator
• Organization: Massachusetts General Hospital

jwang23@mgh.harvard.edu

617-643-2729

Study Officials

• Jingping Wang, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 26, 2021
• Study Start: June 18, 2021
• Primary Completion: April 23, 2023
• Study Completion: April 23, 2023
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)