Trial Outcomes & Findings for The Effect of Opioid-Free Anesthesia in TMJ Surgery (NCT NCT04724759)
NCT ID: NCT04724759
Last Updated: 2024-11-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Through in-hospital study completion, an average of 1 day
Results posted on
2024-11-21
Participant Flow
Participant milestones
| Measure |
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.
|
Standard Anesthesia
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Opioid-Free Anesthesia in TMJ Surgery
Baseline characteristics by cohort
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Continuous
|
38.0 years
n=99 Participants
|
36.0 years
n=107 Participants
|
37.50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Through in-hospital study completion, an average of 1 dayPopulation: Worst PACU Pain Score - Opioid Free 4.9 (2.4) Worst PACU Pain Score - Standard of Care (Control) 4.4 (2.8)
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.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Pain Score
|
4.9 units on a scale
Standard Deviation 2.4
|
4.4 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 48 hours postoperativelyIntraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Perioperative Opioid Use
|
21 morphine milligram equivalents
Standard Deviation 70
|
20 morphine milligram equivalents
Standard Deviation 66.7
|
SECONDARY outcome
Timeframe: Through in-hospital study completion, an average of 1 dayPopulation: Time to Rescue Analgesia (minutes), Median \[Q1,Q3\] Opioid Free: 104.0 \[84.5, 224.0\] Standard of Care (Control): 83.5 \[51.1, 155.0\]
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Rescue Analgesia in the PACU
|
104.0 Minutes
Interval 84.5 to 224.0
|
83.5 Minutes
Interval 51.1 to 155.0
|
SECONDARY outcome
Timeframe: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hoursSelf-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).
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Pain Satisfaction
8
|
5 Participants
|
6 Participants
|
|
Pain Satisfaction
0
|
1 Participants
|
0 Participants
|
|
Pain Satisfaction
1
|
1 Participants
|
0 Participants
|
|
Pain Satisfaction
2
|
0 Participants
|
0 Participants
|
|
Pain Satisfaction
3
|
0 Participants
|
1 Participants
|
|
Pain Satisfaction
4
|
0 Participants
|
0 Participants
|
|
Pain Satisfaction
5
|
1 Participants
|
1 Participants
|
|
Pain Satisfaction
6
|
0 Participants
|
0 Participants
|
|
Pain Satisfaction
7
|
0 Participants
|
1 Participants
|
|
Pain Satisfaction
9
|
2 Participants
|
2 Participants
|
|
Pain Satisfaction
10
|
18 Participants
|
14 Participants
|
|
Pain Satisfaction
No Survey Completed
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 48 hours postoperativelyThe incidence of ileus, nausea/vomiting, and pruritis will be reported.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Incidence of Opioid Related Adverse Effects
|
6 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Through in-hospital study completion, an average of 1 dayLength of PACU and hospital stay will be reported.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Length of Stay (PACU Discharge)
|
227.0 minutes for PACU
Interval 192.5 to 268.0
|
206.0 minutes for PACU
Interval 176.3 to 244.8
|
SECONDARY outcome
Timeframe: 48 hours postoperativelyPopulation: Postoperative Percocet Use (mg) Opioid Free: 0 \[0, 25\] Standard of Care (Control): 5 \[0, 25\]
The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Percocet Use
|
0 Milligrams
Interval 0.0 to 25.0
|
5 Milligrams
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: Through in-hospital study completion, an average of 1 dayTime to Hospital Discharge will be reported.
Outcome measures
| Measure |
Opioid-free Anesthesia
n=30 Participants
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.
|
Standard Anesthesia
n=30 Participants
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Length of Stay (Hospital Discharge)
|
4.1 Time to Hospital Discharge (hours)
Interval 3.4 to 4.8
|
3.8 Time to Hospital Discharge (hours)
Interval 3.0 to 4.3
|
Adverse Events
Opioid-free Anesthesia
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Standard Anesthesia
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Opioid-free Anesthesia
n=30 participants at risk
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.
|
Standard Anesthesia
n=30 participants at risk
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
16.7%
5/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
30.0%
9/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
|
Skin and subcutaneous tissue disorders
Itching Sensation
|
6.7%
2/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
10.0%
3/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
3.3%
1/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
|
Gastrointestinal disorders
Intestinal/Bowel Obstruction
|
6.7%
2/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
16.7%
5/30 • Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
|
Additional Information
Jingping Wang - Principal Investigator
Massachusetts General Hospital
Phone: 617-643-2729
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place