Temporomandibular Joint Disorders
Conditions
Keywords
Opioid
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.
Interventions
DRUGDexmedetomidine / 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Perioperative Opioid Use | 48 hours postoperatively | Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated. |
| 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. |
| Length of Stay (PACU Discharge) | Through in-hospital study completion, an average of 1 day | Length of PACU and hospital stay will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opioid-free Anesthesia 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.
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. | 30 |
| Standard Anesthesia Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Opioid-free Anesthesia | Standard Anesthesia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 38.0 years | 36.0 years | 37.50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 25 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 23 Participants | 24 Participants | 47 Participants |
| Region of Enrollment United States | 30 Participants | 30 Participants | 60 Participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 9 / 30 | 18 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: Through in-hospital study completion, an average of 1 day
Population: Worst PACU Pain Score - Opioid Free 4.9 (2.4)~Worst PACU Pain Score - Standard of Care (Control) 4.4 (2.8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid-free Anesthesia | Pain Score | 4.9 units on a scale | Standard Deviation 2.4 |
| Standard Anesthesia | Pain Score | 4.4 units on a scale | Standard Deviation 2.8 |
Secondary
Incidence of Opioid Related Adverse Effects
The incidence of ileus, nausea/vomiting, and pruritis will be reported.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid-free Anesthesia | Incidence of Opioid Related Adverse Effects | 6 Participants |
| Standard Anesthesia | Incidence of Opioid Related Adverse Effects | 14 Participants |
Secondary
Length of Stay (Hospital Discharge)
Time to Hospital Discharge will be reported.
Time frame: Through in-hospital study completion, an average of 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid-free Anesthesia | Length of Stay (Hospital Discharge) | 4.1 Time to Hospital Discharge (hours) |
| Standard Anesthesia | Length of Stay (Hospital Discharge) | 3.8 Time to Hospital Discharge (hours) |
Secondary
Length of Stay (PACU Discharge)
Length of PACU and hospital stay will be reported.
Time frame: Through in-hospital study completion, an average of 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid-free Anesthesia | Length of Stay (PACU Discharge) | 227.0 minutes for PACU |
| Standard Anesthesia | Length of Stay (PACU Discharge) | 206.0 minutes for PACU |
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. 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).
Time frame: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Opioid-free Anesthesia | Pain Satisfaction | 2 | 0 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 5 | 1 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 0 | 1 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 6 | 0 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | No Survey Completed | 2 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 7 | 0 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 8 | 5 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 3 | 0 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 9 | 2 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 4 | 0 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 10 | 18 Participants |
| Opioid-free Anesthesia | Pain Satisfaction | 1 | 1 Participants |
| Standard Anesthesia | Pain Satisfaction | 10 | 14 Participants |
| Standard Anesthesia | Pain Satisfaction | 1 | 0 Participants |
| Standard Anesthesia | Pain Satisfaction | 3 | 1 Participants |
| Standard Anesthesia | Pain Satisfaction | No Survey Completed | 5 Participants |
| Standard Anesthesia | Pain Satisfaction | 7 | 1 Participants |
| Standard Anesthesia | Pain Satisfaction | 0 | 0 Participants |
| Standard Anesthesia | Pain Satisfaction | 2 | 0 Participants |
| Standard Anesthesia | Pain Satisfaction | 4 | 0 Participants |
| Standard Anesthesia | Pain Satisfaction | 5 | 1 Participants |
| Standard Anesthesia | Pain Satisfaction | 6 | 0 Participants |
| Standard Anesthesia | Pain Satisfaction | 8 | 6 Participants |
| Standard Anesthesia | Pain Satisfaction | 9 | 2 Participants |
Secondary
Percocet Use
The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Time frame: 48 hours postoperatively
Population: Postoperative Percocet Use (mg) Opioid Free: 0 \[0, 25\] Standard of Care (Control): 5 \[0, 25\]
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid-free Anesthesia | Percocet Use | 0 Milligrams |
| Standard Anesthesia | Percocet Use | 5 Milligrams |
Secondary
Perioperative Opioid Use
Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Time frame: 48 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid-free Anesthesia | Perioperative Opioid Use | 21 morphine milligram equivalents | Standard Deviation 70 |
| Standard Anesthesia | Perioperative Opioid Use | 20 morphine milligram equivalents | Standard Deviation 66.7 |
Secondary
Rescue Analgesia in the PACU
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Time frame: Through in-hospital study completion, an average of 1 day
Population: Time to Rescue Analgesia (minutes), Median \[Q1,Q3\] Opioid Free: 104.0 \[84.5, 224.0\] Standard of Care (Control): 83.5 \[51.1, 155.0\]
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid-free Anesthesia | Rescue Analgesia in the PACU | 104.0 Minutes |
| Standard Anesthesia | Rescue Analgesia in the PACU | 83.5 Minutes |