Clinical trial NCT04724759
Conditions: Temporomandibular Joint Disorders
Keywords: Opioid
Sponsor: Massachusetts General Hospital
Start date: 2021-06-18; Completion date: 2023-04-23
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
Interventions: intervention 1: Dexmedetomidine / Ketamine / Lidocaine
Intervention descriptions: intervention 1: 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.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
THE EFFECT OF OPIOID-FREE 
ANESTHESIA IN TMJ SURGERY:  
A PROSPECTIVE STUDY 
 
Principal Investigator: Jingping Wang, MD 
Detailed Study Protocol 
Version 12/01/2021 
 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
2 
Table of Contents 
Background and Significance .................................................................................................................................... 3 
Specific Aims ............................................................................................................................................................. 3 
Subject Selection ....................................................................................................................................................... 3 
Subject Recruitment .................................................................................................................................................. 4 
Consent Procedures .................................................................................................................................................. 4 
Randomization and Masking .................................................................................................................................... 5 
Drug Administration ................................................................................................................................................. 5 
Study Procedures ...................................................................................................................................................... 5 
Withdrawal or Early Termination of Study Procedures ............................................................................................. 6 
Other Standards of Care ........................................................................................................................................... 6 
Study Endpoints and Outcomes ................................................................................................................................ 6 
Sample Size Calculation ............................................................................................................................................ 7 
Statistical Analysis .................................................................................................................................................... 7 
Risks and Discomforts ............................................................................................................................................... 7 
Potential Benefits ...................................................................................................................................................... 8 
Data Collection, Source Documents and Confidentiality ........................................................................................... 8 
 
 
 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
3 
Background and Significance 
 
The intensity of pain after OMF surgery is often underestimated, and inadequate pain control may be 
associated with poor quality of recovery, increased opioid requirement and increased hospital length of stay 
postoperatively. 
 
This population of OMF surgery is also susceptible to opioid-induced complications such as respiratory 
depression and postoperative nausea and vomiting, and may benefit from opioid-free anesthetic 
techniques.  
 
Opioid free anesthesia is a safer option for anesthesia administration that maximizes a patient's respiratory 
ability and aggressively treats their pain, while eliminating the unwanted side effects of opioids. Although 
subanesthetic infusions of lidocaine, ketamine or dexmedetomidine supplemented with other intravenous 
agents and inhaled anesthetic has been used widely in surgeries, it's effect in postoperative pain 
management and overall hospital course has not been systematically studied in OMF surgeries. 
 
Specific Aims 
 
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.  
 
We hypothesize that by using an opioid free anesthetic technique, we can reduce the patients’ 
postoperative pain score, reduce the amount of time until the patient meets the criteria for discharge from 
PACU, and reduce postoperative opioid consumption while in the PACU and within the subsequent 24 
hours with less side effect of opioid usage.  
 
Subject Selection 
 
This study will enroll 60 patients undergoing TMJ surgery at Massachusetts General Hospital. Specifically 
we aim to enroll patients undergoing arthroscopic surgical procedures.  We will not exclude repeat 
surgeries, as the anticipated intraoperative medication use and postoperative course is believed to be 
similar to patients undergoing TMJ for the first time. Specific inclusion and exclusion criteria are detailed 
below:  
 
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 
 
We will enroll patients without regard to race, sex, or ethnicity.    
 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
4 
Subject Recruitment  
 
Prescreening will be accomplished by reviewing the operating room schedule and surgical consult lists for 
patients who are scheduled to undergo TMJ surgery. Patient medical records will be reviewed for inclusion 
and exclusion criteria. All patients meeting inclusion criteria with no exclusions will be considered eligible 
for participation and approached as outlined below. 
 
This study will utilize multiple modalities to recruit potential patients. Whenever possible a member of the 
study team will meet the patient at a preoperative clinic visit. At this time the study procedures will be 
explained in detail. The subject will be provided with a copy of the consent form and the consent process 
may be initiated. The patient will be provided with ample time to consider study participation, and will be 
encouraged to discuss participation with their surgeon or family members prior to making a decision.  
Subjects who are contacted in person and require additional time to consider participation will be 
reapproached on the morning of surgery in the preoperative holding area.   
 
In some cases however it is not possible to meet with patients in person prior to their scheduled surgery. 
This is increasingly common as telehealth is incorporated into the preoperative arena. For patients with 
whom we are unable to connect at their preoperative clinic visit, we will either contact them through Patient 
Gateway Targeted Research Announcements or mail them a recruitment letter (if they do not use Patient 
Gateway). Both methods of patient recruitment will have information that describes the study procedures 
and allows them to opt out of participating in the study. Importantly we will obtain approval from the patient’s 
surgeon or primary care physician prior to contacting any participants.  
 
The recruitment packet that will be mailed to participants includes a letter that is signed by both the principal 
investigator and the patients surgeon/PCP, as well as copy of the informed consent form.  Participants who 
are not interested in participation will be provided with a phone number and email address that they can 
contact in order to opt out of participating. If a subject remains interested in participating, they will be 
approached in person or via phone by a physician member of the research team to conduct the full informed 
consent process. Importantly, subjects can decide to participate or not in this study at this time. By providing 
the consent form in advance of the preoperative visit, this provides subjects ample time to consider 
participation and ask any questions.  
 
All patients will be reminded that participation is entirely voluntary and that their decision to participate will 
in no way affect the care that they receive.   
 
Consent Procedures  
 
Written informed consent will be obtained by one of the participating physician researchers of the study. At 
the time of consent, all study procedures will be explained in detail, including the associated risks and benefits.  
The subjects will have the opportunity to ask any and all questions, and will be reminded that participation is 
voluntarily.  Subjects will be reminded that their decision to participate or not will in no way affect the care that 
they would otherwise receive as part of their surgery.   
 
All subjects will be consented with curtains drawn or the door closed, assuring patient privacy.  Written 
informed consent will then be obtained prior to surgery and initiation of any research procedures. 
 
In addition to in-person consent, this study will also utilize a MGB REDCap eConsent. Participants who have 
not contacted the study team (to opt out) will be contacted via phone prior to surgery by one of the physician 
study team members. During this call the physician will describe all of the study procedures and ensure all of 
the patient’s questions have been answered.  If after this conversation, the patient agrees to participate, the 
study team will send them a link to the eConsent via email. The participant will then be able to review the 
consent form and sign to consent. The study physician will also receive a REDCap link to sign off on consent. 
A collated copy will be returned to the participant for their records. Patients who prefer to consent in person 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
5 
or those who are unable to complete the eConsent will be approached in person on the morning of their 
surgery as detailed above.  
 
Randomization and Masking 
 
Patients who consent to participate will be randomized to one of two groups in a 1:1 fashion using permuted 
block randomization. The randomization schema will be developed by a statistician and displayed in the 
REDCap randomization module.   
 
Because this study involves two distinctly different medication administration strategies in the operating 
room, it is not possible to blind the treating anesthesiologist.  Therefore this study will not be blinded to the 
treating provider. The patient will remain blinded to their assigned randomization group in order to obtain 
unbiased assessments of pain and anesthesia outcomes postoperatively.  
 
Drug Administration  
 
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.  
o 
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.  
o 
The exposure group will not receive opioid analgesic during the intraoperative period. 
  
• 
Group 2 – Standard Anesthesia Patients: Patients who undergo the standard of care and receive 
opioids as part of their anesthetic regimen. 
o 
In this group patients will receive fentanyl (1mcg/kg or equivalence dose) every 45 minutes 
until the end of surgery, or as needed clinically. 
 
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.  
 
Study Procedures 
 
Following intraoperative drug administration patients will be followed until discharge from the PACU to 
assess study endpoints while in the hospital. This includes a complete review of their medical record. 
Clinically documented pain scores will be abstracted from the medical record based off nursing 
documentation which routinely occurs every 15 minutes. Medication administration, particularly with respect 
to postoperative opioids, and anesthesia-related complication (postoperative nausea, vomiting, etc.) will be 
recorded.  
 
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.  This Revised American Pain Society Patient Outcome 
Questionnaire is a validated scale of 12 questions that takes approximately five minutes to complete.   
 
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 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
6 
complication they might experience at home.  This diary will help to avoid recall bias when reporting these 
to the study team.  Patients will then be contacted by the study team after postoperative day two to collect 
the information from the medication diary. The patient will be asked to mail or email a completed copy of 
the Medication Diary to the study team, if possible.  If these cannot be returned a complete record will be 
obtained verbally during the phone call. At this point the subjects participation will be considered complete.  
 
Withdrawal or Early Termination of Study Procedures   
 
Regardless of the randomization group patients are assigned to, the attending anesthesiologist has the 
discretion to treat any pain or discomfort, as needed clinically, as deemed appropriate. If subjects require 
additional pain medication dosing to achieve comfort, it will be provided to ensure adequate analgesia for 
both of groups. We will attempt to minimize crossover from the opioid-free group by standardizing the 
anesthetic regimen, as outlined above in the Drug Administration Section, while providing adjuvant non-
opioid strategies first. This will not constitute termination of the study.  If this is the case, these patients will 
be analyzed according to the intention-to-treat principle. Participants will be encouraged to complete the 
study, as planned, through postoperative day two.  
 
As with any research study, participation is completely voluntary. At any time the patient can request to 
withdraw from the study and all study procedures will be stopped.     
 
Other Standards of Care  
 
Importantly, enrolled patients will undergo the current institutional standards of care for their surgery and 
preoperative care. This includes, following adequate oxygenation, propofol (2-2.5 mg/kg), succinylcholine 
(1 mg/kg) and lidocaine (IV 1-1.5mg/kg bolus) as part of induction, and patients receiving general 
anesthesia with nasal intubation. 
 
 All patients will take receive PO acetaminophen 950 mg before going to the operating room unless 
otherwise contraindicated. Anesthesia maintenance will be maintained using a sevoflurane concentration 
of 0.7-1.3 minimum alveolar concentration (MAC). Ketorolac (30 mg IV) will be administered at the end of 
the case at the clinician's discretion. Local multimodal anesthesia infiltration will be performed before 
closure by the surgeon for all cases per standard protocol. Multimodal anti-emetics including 
dexamethasone (12mg IV), ondansetron (2-4 mg IV), haloperidol (1mg IV) or Toradol (30mg IV) will be 
administered prior to emergence per standard protocol, unless otherwise contraindicated.  
 
Patients will be discharged home the same day with the following standardized discharge medications for 
TMJ arthroscopic surgery (unless otherwise contraindicated): Percocet (5/325mg, PO Q6H PRN pain; disp: 
20 tablets), Mobic (7.5mg PO Q daily; disp: 60 tablets), and Flexeril (5mg PO QHS; disp: 60 tablets).  
 
Patients would receive the treatments above regardless of whether or not they decided to participate in the 
study.   
 
Study Endpoints and Outcomes 
 
Primary and secondary study endpoints include: 
 
Primary Endpoint 
1. Postoperative Pain Score: Pain will be measured using the eleven point (0 to 10) numeric rating 
scale. 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.   
 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
7 
Secondary Endpoints 
2. Perioperative Opioid Use: Intraoperative and postoperative opioid consumption in the first 12,  
24 and 48 hours postoperatively will be evaluated.    
3. The use, dosage and time to use of rescue analgesia in the PACU  
4. The incidence of postoperative nausea and vomiting in PACU and at home after surgery 
5. Pain Satisfaction: Self-report pain satisfaction will be assessed at the time of PACU discharge 
using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).   
6. Incidence of Opioid Related Adverse Effects: The incidence of ileus, nausea/vomiting, and 
pruritis will be reported.   
7. Length of PACU and Hospital Stay  
8. Total dose of Percocet used at 24 and 48 hours after surgery 
 
Sample Size Calculation 
 
Using data from previous study (Ahiskalioglu et al. Multimodal Approach to Postoperative Pain. J Oral 
Maxillofac Surg 2016.), the pain score in the standard of care (placebo) group immediately postoperatively 
was as high as 6. Assuming increased variability (standard deviation of 2.5) in the current study and a two 
point reduction in the opioid free group, 1:1 sampling ratio, type I error of 0.05 and power of 0.8, a total of 
26 subjects per group are required.  Given the expected potential for missing data, we will enroll 30 patients 
per group (N = 60 overall) in order to adequately power our study.   
 
Statistical Analysis  
 
Descriptive statistics of the data will be presented.  Continuous data will be reported as mean ± standard 
deviations or medians (interquartile range) depending on the distribution of the data and assessed with a 
parametric t-test or non-parametric equivalent, as appropriate. Categorical data will be reported as 
frequencies and proportions and assessed with a chi-square or Fishers exact test.  
 
Our primary outcome will be assessed by comparing the worst postoperative pain score between those 
who are with opioid free anesthesia (Group I) and those who are with opioid anesthesia (Group II). A t-test 
or non-parametric equivalent will be employed.  Although we expect randomization to account for baseline 
differences, multivariable linear regression may be employed to assess differences in the outcomes 
between groups. Secondary continuous outcomes (e.g. opioid consumption) will be assessed in a similar 
fashion.  Secondary categorical outcomes will be assessed with a chi-square test, employing logistic 
regression as necessary to adjust for baseline differences between groups.  In the case of both linear and 
logistic regression, models will be adjusted for clinically relevant differences at baseline, or variables for 
which the p-value is < 0.10 on the univariate level.  Given that some data may be collected at multiple time 
points (e.g. pain scores), we will employ the use of paired t-tests and repeated measures regression to 
account for the correlation between observations, as necessary. For all analyses two-sided p-values < 0.05 
considered statistically significant.   
 
Risks and Discomforts 
 
This study will utilize two routinely employed intraoperative opioid strategies. Thus, there is no anticipated 
physical risks outside those experienced as part of their routine care. 
 
This study will not ask any sensitive information as part of the study questionnaires; therefore this possibility 
of psychosocial risks is limited. As with any research study there is the possibility of a breach of 
confidentiality.  Investigators are explicitly trained in the appropriate handling of research data. Physical 
(locked offices) and electronic (password protected computers) barriers will be used to ensure 
confidentiality.   
 


The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study 
Principal Investigator: Jinping Wang, MD 
 
 
Detailed Protocol | Version 12/01/2021 
 
 
8 
The principal investigator, Dr.  Wang, Jinping will be responsible for monitoring and assure the safety and 
welfare of subjects, the validity and the integrity of the data, and adherence to the IRB-approved protocol. 
Any events occurring prior to the study procedure will be recorded as medical history. Any adverse events 
(AE) that occur during the course of this trial will be recorded and will be followed until resolution, study 
completion or termination.  Each event will be recorded as it happens (or as soon as it becomes known to 
study staff). Any serious or unexpected adverse events related to study, should they occur, will be 
expeditiously (within 5 working days) be reported to MGB IRB in accordance with the IRB reporting 
requirements. 
 
Potential Benefits 
 
It is hypothesized that use of opioid free anesthesia may lead to improved overall postoperative pain levels, 
less postoperative opiate medication, and shorter time to discharge from the PACU. Individual health 
benefits however cannot be guaranteed.  
 
It is likely that society as a whole will benefit from increased knowledge of the role of intraoperative opioid 
strategies on postoperative recovery, pain and anesthesia related complications.  Given the number of 
patients who currently undergo TMJ surgery and the rising opioid crisis, this study could have important 
implications for a large number of patients. 
 
Data Collection, Source Documents and Confidentiality  
 
Data will be collected in a study specific REDCap (Research Electronic Data Capture) account hosted on 
a MGB server. Data collection for this study includes but is not limited to: 
• 
Demographic data (age, race, ethnicity, height, weight, body mass index, sex)  
• 
Baseline medical comorbidities 
• 
Surgical characteristics (ex. repeated surgery, unilateral/bilateral, duration) 
• 
Intraoperative and postoperative medication administration (opioids and adjuvants) 
• 
Pain scores and pain satisfaction survey data  
• 
Postoperative complications (ex. ileus, nausea, vomiting) 
• 
PACU and hospital characteristics (ex. length of stay, unplanned admission)  
 
All participating investigators have received human subjects training. Study data will be maintained in a 
secure and encrypted environment (locked in the PI’s office) or REDCap and the data will be kept on a 
password protected hospital PC accessible to only study investigators. Computers and data collected on 
paper will be stored in locked rooms. For all analyses subjects will be identified only by their unique coded 
study ID number assigned for the sole purpose of this project. Access to the study crosswalk will be 
restricted to the study staff included on the protocol.  Limited information will be retained on patients who 
are prescreened and do not qualify, or who are approached and declined, for the purposes of generating a 
CONSORT diagram for the trial. The principal investigator will ensure the safety and integrity of all study 
data and the confidentiality of individual participants.   
 
Throughout the life of the study the principal investigator and study staff will be responsible for monitoring 
the validity and integrity of data. The principal investigator and/or study staff will review the accuracy and 
completeness of reports, documents, and informed consents. The principal investigator will monitor 
adherence to patient confidentiality and other applicable guidelines and will be responsible for overall study 
performance. The Principal Investigator will therefore be responsible for data integrity, and will ensure study 
compliance with the IRB approved protocol and applicable regulations. 
 
 
 

ICF_001.pdf: 
Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
Page 1 of 12 
 
 
Subject Identification 
Protocol Title: The Effect of Opioid-Free Anesthesia in TMJ Surgery: A 
Prospective Study 
 
Principal Investigator: Jinping Wang, MD  
 
Site Principal Investigator:  
 
Description of Subject Population: Surgical Patients 
About this consent form 
 
Please read this form carefully.  It tells you important information about a research study.  A 
member of our research team will also talk to you about taking part in this research study.  
People who agree to take part in research studies are called “subjects.”  This term will be used 
throughout this consent form. 
 
Partners HealthCare System is made up of Partners hospitals, health care providers, and 
researchers.  In the rest of this consent form, we refer to the Partners system simply as 
“Partners.” 
 
If you decide to take part in this research study, you must sign this form to show that you want to 
take part.  We will give you a signed copy of this form to keep. 
 
Key Information 
 
Taking part in this research study is up to you.  You can decide not to take part.  If you decide to 
take part now, you can change your mind and drop out later.  Your decision won’t change the 
medical care you get within Partners now or in the future.   
 
The following key information is to help you decide whether or not to take part in this research 
study.  We have included more details about the research in the Detailed Information section that 
follows the key information. 
 
Why is this research study being done? 
In this research study we want to learn more about the effect of an opioid-free anesthesia strategy 
in the operating room on postoperative recovery in patients undergoing facial surgery. 
 
How long will you take part in this research study? 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 2 of 12 
 
 
Subject Identification 
 
If you decide to join this research study, it will take you about three days to complete the study. 
This includes the day of surgery and two days after. You do no need to return to the hospital for 
these study visits.  
 
What will happen if you take part in this research study? 
If you decide to join this research study, you will be randomized, like the flip of a coin, to either 
an opioid-free group or to the control group. If you are randomized to the opioid-free group, you 
will receive all the usual medications for surgery, however we will not give you additional 
opioid medications while in the operating room. When you are transferred to the post-anesthesia 
recovery area, all usual medications will be resumed, as necessary. It is important to note that 
even if you are in the opioid free group while in the operating room, you can still receive opioid 
medications if you experience any discomfort. Additionally this study will include review of 
your medical record and a phone call two days after your surgery to see what medications you 
took after surgery and evaluate how you are recovering.  
 
Why might you choose to take part in this study? 
We cannot promise any benefits to you from taking part in this research study.  However, 
possible benefits may include reduced postoperative pain or side effects such as nausea or 
vomiting after surgery.  Others undergoing this surgery may benefit in the future from what we 
learn in this study. 
 
Why might you choose NOT to take part in this study? 
Taking part in this research study has some risks and requirements that you should consider 
carefully.  This study will utilize two routinely used strategies for administering medications in 
the operating room. The risks of the surgery and anesthetic drugs, which are part of your 
standard care and which you would be receiving whether you participate in the study or not, will 
be discussed with you separately as part of the clinical consent process. Thus, there is no 
anticipated risk outside those experienced as part of their routine care. As with any research 
study there is small possibility of a breach of confidentiality.  
 
A detailed description of side effects, risks, and possible discomforts can be found later in this 
consent form in the section called “What are the risks and possible discomforts from being in this 
research study?” 
 
What other treatments or procedures are available for your condition? 
You do not have to take part in this study. You can undergo surgery according to the current 
institutional standards of care without participating in this study.
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 3 of 12 
 
 
Subject Identification 
If you have questions or concerns about this research study, whom can 
you call? 
 
You can call us with your questions or concerns.  Our telephone numbers are listed below.  Ask 
questions as often as you want.   
 
Dr. Wang is the person in charge of this research study.  You can call him at (617) 643-2729 [M-
F 9-5].  You can also call the study team at (617) 726-9252 [M-F 9-5] with questions about this 
research study.  
 
If you want to speak with someone not directly involved in this research study, please contact 
the Partners Human Research Committee office.  You can call them at 857-282-1900. 
 
You can talk to them about: 
§ Your rights as a research subject 
§ Your concerns about the research 
§ A complaint about the research 
§ Any pressure to take part in, or to continue in the research study 
 
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 4 of 12 
 
 
Subject Identification 
Detailed Information 
 
Why is this research study being done? 
 
Patients undergoing surgery on their jaw (temporomandibular joint, TMJ) may experience pain 
after surgery that is often complicated by the opioid medications that are used to treat pain.  
These complications include the possibility of nausea and vomiting after surgery.  
 
Anesthesiologists routinely employ several strategies to manage the medications they administer 
while in the operating room, however the optimal strategy is not clear. In this study we aim to 
evaluate two strategies, namely the use of opioids intraoperatively or not, to evaluate the effect 
on postoperative recovery after TMJ surgery.  
 
Who will take part in this research? 
 
About 60 people will take part in this research study at Massachusetts General Hospital.  
 
What will happen in this research study? 
 
If you decide to participate in this study the following things will happen: 
 
• You will be randomly assigned, like the flip of a coin, to one of two common 
anesthesia strategies: 
o Standard Anesthesia Group: If you are randomized to this group you will undergo 
surgery according to the current institutional standards of care, which includes the 
receipt of opioid medications in the operating room. 
o Opioid-Free Anesthesia Group: If you are assigned to this group you will receive 
all the usual anesthetic medications you would normally receive for surgery, 
however this will not include any opioid medications while in the operating room. 
In order to manage your care during surgery, you may receive other medications to 
treat pain that are not considered opioids. These are all medications that you might 
routinely receive in the operating room.  
 
Neither you nor the study team will be able to choose which group you are assigned to. 
Additionally, once you are randomly assigned, only the study team and your surgical team 
will know which group you were assigned to. We will not tell you which group you were 
assigned to.  
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 5 of 12 
 
 
Subject Identification 
• It is important to know that regardless of which group you are assigned to, your pain 
will be treated. All other aspects of your care and surgery will follow the current 
institutional standards of care, including preoperative and postoperative medication 
administration and plans for hospital discharge after surgery.   
 
• Regardless of which group you are assigned to, we will review your medical record to 
collect data on your surgery, the medications you received while in the operating and 
recovery rooms, your pain after surgery, and other information about your hospital stay.  
 
• We will ask you a brief questionnaire about your satisfaction with your pain management 
when you are leaving the post anesthesia care unit. This survey takes approximately five 
minutes to complete.  
 
• We will ask you to complete a medication diary for the first two days after surgery 
while you are at home.  You will be asked to record all pain medications administered in 
the first two days after your surgery, as well as information about any pain you are 
experiencing every 12 hours. This diary will also ask you to record whether or not you 
experienced any nausea or vomiting after you left the hospital. We will call you after two 
days to collect this data from you over the phone. After two days your study participation 
will be considered complete.  
 
Study Information Included in Your Electronic Medical Record  
A notation that you are taking part in this research study may be made in your electronic medical 
record.  Information from the research that relates to your general medical care may be included 
in the record (for example, list of allergies, results of standard blood tests done at the hospital 
labs). 
 
How may we use and share your samples and health information for other 
research?
 
The information we collect in this study may help advance other research.  If you join this study, 
we may remove all information that identifies you (for example, your name, medical record 
number, and date of birth) and use these de-identified data in other research.  It won’t be possible 
to link the information or samples back to you.  Information may be shared with investigators at 
our hospitals, at other academic institutions or at for-profit, commercial entities.  You will not be 
asked to provide additional informed consent for these uses. 
 
Will you get the results of this research study? 
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 6 of 12 
 
 
Subject Identification 
No.  The research study we are doing is only a stepping stone in understanding the effect of 
intraoperative opioids.  Therefore, no information about the results of this research study or the 
results of your individual participation in the research study will be given to you or your doctor.  
Tests done for the research using your samples will not be useful in directing your medical 
treatment.  The results of the tests will not be placed in your medical record.    
 
What are the risks and possible discomforts from being in this research 
study? 
 
In this study we are evaluating two different anesthetic strategies that are routinely employed as 
part of the standard of care for TMJ surgery.  The risks of the surgery and anesthetic drugs, 
which are part of your standard care and which you would be receiving whether you participate 
in the study or not, will be discussed with you separately as part of the clinical consent process. 
There are therefore no anticipated physical risks associated with this research study outside of 
what you might experience as part of your routine care. There may be other risks that are 
currently unknown. 
 
As with any research study, there is a small risk of a breach of confidentiality. Investigators are 
explicitly trained in the appropriate handling of research data and will be use both physical 
(locked offices) and electronic (password protected computers) barriers to maintain 
confidentiality.  
 
What are the possible benefits from being in this research study? 
 
We cannot promise any benefits to you from taking part in this research study.  However, 
possible benefits may include reduced postoperative pain or side effects such as nausea or 
vomiting after surgery.  Others undergoing this surgery may benefit in the future from what we 
learn in this study. 
 
What other treatments or procedures are available for your condition? 
 
You do not have to take part in this study. You can undergo surgery according to the current 
institutional standards of care without participating in this study. 
 
Can you still get medical care within Partners if you don’t take part in 
this research study, or if you stop taking part?  
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 7 of 12 
 
 
Subject Identification 
Yes.  Your decision won’t change the medical care you get within Partners now or in the future.  
There will be no penalty, and you won’t lose any benefits you receive now or have a right to 
receive.  
 
We will tell you if we learn new information that could make you change your mind about taking 
part in this research study. 
 
 
What should you do if you want to stop taking part in the study? 
 
If you take part in this research study, and want to drop out, you should tell us.  We will make 
sure that you stop the study safely.  We will also talk to you about follow-up care, if needed. 
 
Also, it is possible that we will have to ask you to drop out of the study before you finish it.  If 
this happens, we will tell you why.  We will also help arrange other care for you, if needed.  
 
 
Will you be paid to take part in this research study? 
 
You will not be paid for taking part in this research study. 
 
We may use your information to develop a new product or medical test to be sold.  The Sponsor, 
hospital, and researchers may benefit if this happens.  There are no plans to pay you if your 
samples or information are used for this purpose. 
 
What will you have to pay for if you take part in this research study? 
 
Study funds will pay for certain study-related items and services.  We may bill your health 
insurer for, among other things, routine items and services you would have received even if you 
did not take part in the research.  You will be responsible for payment of any deductibles and co-
payments required by your insurer for this routine care or other billed care.  If you have any 
questions about costs to you that may result from taking part in the research, please speak with 
the study doctors and study staff.  If necessary, we will arrange for you to speak with someone in 
Patient Financial Services about these costs.  
 
What happens if you are injured as a result of taking part in this 
research study?
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 8 of 12 
 
 
Subject Identification 
We will offer you the care needed to treat any injury that directly results from taking part in this 
research study.  We reserve the right to bill your insurance company or other third parties, if 
appropriate, for the care you get for the injury.  We will try to have these costs paid for, but you 
may be responsible for some of them.  For example, if the care is billed to your insurer, you will 
be responsible for payment of any deductibles and co-payments required by your insurer. 
 
Injuries sometimes happen in research even when no one is at fault.  There are no plans to pay 
you or give you other compensation for an injury, should one occur.  However, you are not 
giving up any of your legal rights by signing this form. 
 
If you think you have been injured or have experienced a medical problem as a result of taking 
part in this research study, tell the person in charge of this study as soon as possible.  The 
researcher's name and phone number are listed in the beginning of this consent form.
 
 
If you take part in this research study, how will we protect your privacy? 
 
Federal law requires Partners to protect the privacy of health information and related information 
that identifies you.  We refer to this information as “identifiable information.” 
 
In this study, we may collect identifiable information about you from: 
• Past, present, and future medical records 
• Research procedures, including research office visits, tests, interviews, and 
questionnaires 
 
Who may see, use, and share your identifiable information and why they may need 
to do so: 
• Partners researchers and staff involved in this study 
• The sponsor(s) of the study, and people or groups it hires to help perform this research or 
to audit the research 
• Other researchers and medical centers that are part of this study 
• The Partners ethics board or an ethics board outside Partners that oversees the research 
• A group that oversees the data (study information) and safety of this study 
• Non-research staff within Partners who need identifiable information to do their jobs, 
such as for treatment, payment (billing), or hospital operations (such as assessing the 
quality of care or research) 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 9 of 12 
 
 
Subject Identification 
• People or groups that we hire to do certain work for us, such as data storage companies, 
accreditors, insurers, and lawyers 
• Federal agencies (such as the U.S. Department of Health and Human Services (DHHS) 
and agencies within DHHS like the Food and Drug Administration, the National 
Institutes of Health, and the Office for Human Research Protections), state agencies, and 
foreign government bodies that oversee, evaluate, and audit research, which may include 
inspection of your records 
• Public health and safety authorities, if we learn information that could mean harm to you 
or others (such as to make required reports about communicable diseases or about child 
or elder abuse) 
• Other:        
 
Some people or groups who get your identifiable information might not have to follow the same 
privacy rules that we follow and might use or share your identifiable information without your 
permission in ways that are not described in this form.  For example, we understand that the 
sponsor of this study may use your identifiable information to perform additional research on 
various products or conditions, to obtain regulatory approval of its products, to propose new 
products, and to oversee and improve its products’ performance.  We share your identifiable 
information only when we must, and we ask anyone who receives it from us to take measures to 
protect your privacy.  The sponsor has agreed that it will not contact you without your 
permission and will not use or share your identifiable information for any mailing or marketing 
list.  However, once your identifiable information is shared outside Partners, we cannot control 
all the ways that others use or share it and cannot promise that it will remain private. 
 
Because research is an ongoing process, we cannot give you an exact date when we will either 
destroy or stop using or sharing your identifiable information.  Your permission to use and share 
your identifiable information does not expire. 
 
The results of this research study may be published in a medical book or journal, or used to teach 
others.  However, your name or other identifiable information will not be used for these 
purposes without your specific permission. 
 
Your Privacy Rights 
 
You have the right not to sign this form that allows us to use and share your identifiable 
information for research; however, if you don’t sign it, you can’t take part in this research study. 
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 10 of 12 
 
 
Subject Identification 
You have the right to withdraw your permission for us to use or share your identifiable 
information for this research study.  If you want to withdraw your permission, you must notify 
the person in charge of this research study in writing.  Once permission is withdrawn, you cannot 
continue to take part in the study. 
 
If you withdraw your permission, we will not be able to take back information that has already 
been used or shared with others, and such information may continue to be used for certain 
purposes, such as to comply with the law or maintain the reliability of the study. 
 
You have the right to see and get a copy of your identifiable information that is used or shared 
for treatment or for payment.  To ask for this information, please contact the person in charge of 
this research study.  You may only get such information after the research is finished.  
 
 
Informed Consent and Authorization 
 
Statement of Person Giving Informed Consent and Authorization 
 
§ I have read this consent form. 
§ This research study has been explained to me, including risks and possible benefits (if 
any), other possible treatments or procedures, and other important things about the study. 
§ I have had the opportunity to ask questions. 
§ I understand the information given to me. 
 
Signature of Subject: 
 
I give my consent to take part in this research study and agree to allow my health information to 
be used and shared as described above. 
 
 
 
 
 
 
 
 
Subject 
Date 
Time  
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 11 of 12 
 
 
Subject Identification 
 
 
Signature of Study Doctor or Person Obtaining Consent: 
 
Statement of Study Doctor or Person Obtaining Consent 
 
§ I have explained the research to the study subject. 
§ I have answered all questions about this research study to the best of my ability. 
 
 
 
 
 
 
 
 
Study Doctor or Person Obtaining Consent 
Date 
Time 
 
 
 


Partners HealthCare System 
Research Consent Form 
 
 
 
General Consent Form Template 
Version Date:  January 2019 
 
 
 
 
Page 12 of 12 
 
 
Subject Identification 
Consent of Non-English Speaking Subjects Using the “Short Form” in the 
Subject’s Spoken Language 
 
 
Statement of Hospital Medical Interpreter 
As someone who understands both English and the language spoken by the subject, I interpreted, 
in the subject's language, the researcher's presentation of the English consent form.  The subject 
was given the opportunity to ask questions. 
 
 
 
 
 
 
 
 
Hospital Medical Interpreter 
Date 
Time 
 
OR 
 
Statement of Other Individual (Non-Interpreter) 
As someone who understands both English and the language spoken by the subject, I represent 
that the English version of the consent form was presented orally to the subject in the subject’s 
own language, and that the subject was given the opportunity to ask questions. 
 
 
 
 
 
 
 
 
Name 
Date 
Time   
 
 
Consent Form Version:  01/25/2021