Phase 2
N=60
The Effect of Opioid-Free Anesthesia in TMJ Surgery
Temporomandibular Joint Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04724759 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Pain Score — 4.9; 4.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexmedetomidine / Ketamine / Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score |
4.9; 4.4 | — |
| SECONDARY Perioperative Opioid Use |
21; 20 | — |
| SECONDARY Rescue Analgesia in the PACU |
104.0; 83.5 | — |
| SECONDARY Pain Satisfaction |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Incidence of Opioid Related Adverse Effects |
6; 14 | — |
| SECONDARY Length of Stay (PACU Discharge) |
227.0; 206.0 | — |
| SECONDARY Percocet Use |
0; 5 | — |
| SECONDARY Length of Stay (Hospital Discharge) |
4.1; 3.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04724759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.