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NCT Number: NCT04724759

The Effect of Opioid-Free Anesthesia in TMJ Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Precedex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Pain Satisfaction

    Time frame: Completed upon the patient reaching PACU Phase I in the hospital, up to approximately 6 hours

    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).

  4. Incidence of Opioid Related Adverse Effects

    Time frame: 48 hours postoperatively

    The incidence of ileus, nausea/vomiting, and pruritis will be reported.

  5. Length of Stay (PACU Discharge)

    Time frame: Through in-hospital study completion, an average of 1 day

    Length of PACU and hospital stay will be reported.

  6. Percocet Use

    Time frame: 48 hours postoperatively

    The total dose of Percocet used at 24 and 48 hours after surgery will be reported.

  7. Length of Stay (Hospital Discharge)

    Time frame: Through in-hospital study completion, an average of 1 day

    Time to Hospital Discharge will be reported.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

The Effect of Opioid-Free Anesthesia in TMJ Surgery: A Prospective Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2021
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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