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The Effect of Opioid-Free Anesthesia in TMJ Surgery

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ClinicalTrials.gov Identifier: NCT04724759
Recruitment Status : Not yet recruiting
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Jingping Wang, MD, Ph.D., Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 30, 2020
First Posted Date  ICMJE January 26, 2021
Last Update Posted Date January 26, 2021
Estimated Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
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. 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Perioperative Opioid Use [ Time Frame: 48 hours postoperatively ]
    Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
  • Rescue Analgesia in the PACU [ Time Frame: Through in-hospital study completion, an average of 1 day ]
    Use, dosage and time to use of rescue analgesia in the PACU will be reported.
  • Pain Satisfaction [ Time Frame: Through in-hospital study completion, an average of 1 day ]
    Self-report pain satisfaction will be assessed at the time of PACU discharge using the Revised American Pain Society Patient Outcome Questionnaire.
  • Incidence of Opioid Related Adverse Effects [ Time Frame: 48 hours postoperatively ]
    The incidence of ileus, nausea/vomiting, and pruritis will be reported.
  • Length of Stay [ Time Frame: Through in-hospital study completion, an average of 1 day ]
    Length of PACU and hospital stay will be reported.
  • Percocet Use [ Time Frame: 48 hours postoperatively ]
    The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Opioid-Free Anesthesia in TMJ Surgery
Official Title  ICMJE The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Temporomandibular Joint Disorders
Intervention  ICMJE Drug: 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.
Other Name: Precedex
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Dexmedetomidine / Ketamine / Lidocaine
  • No Intervention: Standard Anesthesia
    Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jingping Wang, MD (617) 643 - 2729 JWANG23@mgh.harvard.edu
Contact: Ariel Mueller, MA (617) 726 - 9252 almueller@mgh.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04724759
Other Study ID Numbers  ICMJE 2020P003873
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jingping Wang, MD, Ph.D., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jingping Wang, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP