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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard Anesthesia | No Intervention | Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Opioid Use | Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated. | 48 hours postoperatively |
| Rescue Analgesia in the PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingping Wang, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Standard Anesthesia | Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Worst PACU Pain Score - Opioid Free 4.9 (2.4) Worst PACU Pain Score - Standard of Care (Control) 4.4 (2.8) | Posted | Mean | Standard Deviation | units on a scale | Through in-hospital study completion, an average of 1 day |
|
Adverse event data was collected during the trial. Each participant was assessed within the 48 hours after their scheduled surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jingping Wang - Principal Investigator | Massachusetts General Hospital | 617-643-2729 | jwang23@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2021 | Apr 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2021 | Apr 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007649 | Ketamine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
| 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). | 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. | 48 hours postoperatively |
| Length of Stay (PACU Discharge) | Length of PACU and hospital stay will be reported. | 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. | 48 hours postoperatively |
| Length of Stay (Hospital Discharge) | Time to Hospital Discharge will be reported. | Through in-hospital study completion, an average of 1 day |
| BG001 | Standard Anesthesia | Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Standard Anesthesia | Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. |
|
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| Secondary | Perioperative Opioid Use | Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated. | Posted | Mean | Standard Deviation | morphine milligram equivalents | 48 hours postoperatively |
|
|
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| Secondary | Rescue Analgesia in the PACU | Use, dosage and time to use of rescue analgesia in the PACU will be reported. | 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] | Posted | Median | Inter-Quartile Range | Minutes | Through in-hospital study completion, an average of 1 day |
|
|
|
| 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). | Posted | Count of Participants | Participants | Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours |
|
|
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| Secondary | Incidence of Opioid Related Adverse Effects | The incidence of ileus, nausea/vomiting, and pruritis will be reported. | Posted | Count of Participants | Participants | 48 hours postoperatively |
|
|
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| Secondary | Length of Stay (PACU Discharge) | Length of PACU and hospital stay will be reported. | Posted | Median | Inter-Quartile Range | minutes for PACU | Through in-hospital study completion, an average of 1 day |
|
|
|
| Secondary | Percocet Use | The total dose of Percocet used at 24 and 48 hours after surgery will be reported. | Postoperative Percocet Use (mg) Opioid Free: 0 [0, 25] Standard of Care (Control): 5 [0, 25] | Posted | Median | Inter-Quartile Range | Milligrams | 48 hours postoperatively |
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| Secondary | Length of Stay (Hospital Discharge) | Time to Hospital Discharge will be reported. | Posted | Median | Inter-Quartile Range | Time to Hospital Discharge (hours) | Through in-hospital study completion, an average of 1 day |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 9 |
| 30 |
| EG001 | Standard Anesthesia | Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen. | 0 | 30 | 0 | 30 | 18 | 30 |
| Itching Sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Intestinal/Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
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| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D003510 |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| 2 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| 8 |
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| 9 |
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| 10 |
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| No Survey Completed |
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