Temporomandibular Joint DisordersPhase 2NCT04724759
The Effect of Opioid-Free Anesthesia in TMJ Surgery
A Phase 2 study testing Dexmedetomidine / Ketamine / Lidocaine in people with Temporomandibular Joint Disorders, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Dexmedetomidine / Ketamine / Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2021to 23 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide written informed consent
- Pregnant patients
- Open TMJ Surgeries
- Planned overnight admission
- Mental status disorder or patient who are unable to communicate
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Dexmedetomidine / Ketamine / Lidocaine
- Keywords
- Opioid
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine / Ketamine / LidocaineDrug
Also called Precedex
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through in-hospital study completion, an average of 1 day
Secondary outcomes (7)
Perioperative Opioid Use
Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Measured: 48 hours postoperatively
Rescue Analgesia in the PACU
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Measured: Through in-hospital study completion, an average of 1 day
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).
Measured: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours
Incidence of Opioid Related Adverse Effects
The incidence of ileus, nausea/vomiting, and pruritis will be reported.
Measured: 48 hours postoperatively
Length of Stay (PACU Discharge)
Length of PACU and hospital stay will be reported.
Measured: Through in-hospital study completion, an average of 1 day
Percocet Use
The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Measured: 48 hours postoperatively
Length of Stay (Hospital Discharge)
Time to Hospital Discharge will be reported.
Measured: Through in-hospital study completion, an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start18 Jun 2021
- Primary completion23 Apr 2023
- Study completion23 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingping Wang, MD, Ph.D., Massachusetts General Hospital
- Investigators
- Jingping Wang, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724759
- Sponsor's protocol ID
- 2020P003873
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2020
- Last updated
- 21 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
- ClinicalTrials.gov ID
- NCT04724759
- Acronym / sponsor ID
- 2020P003873
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Opioid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 23 Apr 2023 (actual)
- First posted
- 26 Jan 2021 (actual)
- Results
- Posted 21 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free Anesthesia | Experimental | Drug: Dexmedetomidine / Ketamine / LidocainePatients 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. |
| Standard Anesthesia | No intervention | –Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Inability to provide written informed consent
- Pregnant patients
- Open TMJ Surgeries
- Planned overnight admission
- Mental status disorder or patient who are unable to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine / Ketamine / LidocaineAlso: PrecedexPatients 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. | Drug | Opioid-free Anesthesia |
Primary outcome
Pain Score
Time frame: 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.
7 secondary outcomes
Perioperative Opioid Use
Time frame: 48 hours postoperatively
Rescue Analgesia in the PACU
Time frame: Through in-hospital study completion, an average of 1 day
Pain Satisfaction
Time frame: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours
Incidence of Opioid Related Adverse Effects
Time frame: 48 hours postoperatively
Length of Stay (PACU Discharge)
Time frame: Through in-hospital study completion, an average of 1 day
Percocet Use
Time frame: 48 hours postoperatively
Length of Stay (Hospital Discharge)
Time frame: Through in-hospital study completion, an average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingping Wang, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine / Ketamine / Lidocaine in people with Temporomandibular Joint Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: Through in-hospital study completion, an average of 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.