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The Effect of Opioid-Free Anesthesia in TMJ Surgery

Primary Purpose

Temporomandibular Joint Disorders

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine / Ketamine / Lidocaine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Temporomandibular Joint Disorders focused on measuring Opioid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Opioid-free Anesthesia

Standard Anesthesia

Arm Description

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.

Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Perioperative Opioid Use
Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Rescue Analgesia in the PACU
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Pain Satisfaction
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
The incidence of ileus, nausea/vomiting, and pruritis will be reported.
Length of Stay
Length of PACU and hospital stay will be reported.
Percocet Use
The total dose of Percocet used at 24 and 48 hours after surgery will be reported.

Full Information

First Posted
December 30, 2020
Last Updated
July 14, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04724759
Brief Title
The Effect of Opioid-Free Anesthesia in TMJ Surgery
Official Title
The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Opioid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid-free Anesthesia
Arm Type
Experimental
Arm Description
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 Title
Standard Anesthesia
Arm Type
No Intervention
Arm Description
Patients in this arm will undergo the standard of care and receive opioids as part of their anesthetic regimen.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine / Ketamine / Lidocaine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Score
Description
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.
Time Frame
Through in-hospital study completion, an average of 1 day
Secondary Outcome Measure Information:
Title
Perioperative Opioid Use
Description
Intraoperative and postoperative opioid consumption in the first 12, 24 and 48 hours postoperatively will be evaluated.
Time Frame
48 hours postoperatively
Title
Rescue Analgesia in the PACU
Description
Use, dosage and time to use of rescue analgesia in the PACU will be reported.
Time Frame
Through in-hospital study completion, an average of 1 day
Title
Pain Satisfaction
Description
Self-report pain satisfaction will be assessed at the time of PACU discharge using the Revised American Pain Society Patient Outcome Questionnaire.
Time Frame
Through in-hospital study completion, an average of 1 day
Title
Incidence of Opioid Related Adverse Effects
Description
The incidence of ileus, nausea/vomiting, and pruritis will be reported.
Time Frame
48 hours postoperatively
Title
Length of Stay
Description
Length of PACU and hospital stay will be reported.
Time Frame
Through in-hospital study completion, an average of 1 day
Title
Percocet Use
Description
The total dose of Percocet used at 24 and 48 hours after surgery will be reported.
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jingping Wang, MD
Phone
(617) 643 - 2729
Email
JWANG23@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ariel Mueller, MA
Phone
(617) 726 - 9252
Email
almueller@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingping Wang, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingpng Wang, MD
Phone
617-643-2729
Email
jwang23@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Opioid-Free Anesthesia in TMJ Surgery

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