This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
83
The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
New York University School of Medicine
New York, New York, United States
Morphine Equivalents Used During the First 48 Hours Post-Surgery
Amount of morphine administered during the 48 hours following surgery.
Time frame: Up to 48 Hours Post-Surgery (Day 2)
Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery
The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.'
Time frame: 48 Hours Post-Surgery (Day 2)
Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery
The NPRS is a self-assessment of pain. Participants select a number between 0 and 10 that fits best to their pain intensity, where 0 represents 'no pain at all' and 10 represents 'the worst pain ever possible.'
Time frame: Week 6
Morphine Equivalents Used at 6 Weeks Post-Surgery
Amount of morphine administered during the 6 weeks following surgery.
Time frame: Up to Week 6
Number of Participants Requiring Pressor Use During Intraoperative Period
The intraoperative period begins when the patient is transferred to the operating room table and ends with the transfer of a patient to the Post Anesthesia Care Unit (PACU).
Time frame: From beginning up to end of surgery (Day 0 - typically 1 to 3 hours)
Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
Time frame: Up to 48 Hours Post-Surgery (Day 2)
Length of PACU Stay
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Time frame: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
Length of Hospital Stay
Time frame: From admission up to discharge (Up to 6 Weeks)
Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery
The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery.
Time frame: 48 Hours Post-Surgery (Day 2)
Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery
The QoR-15 is a 15-item self measurement of patients' overall satisfaction with postoperative recovery. Items are ranked on a Likert scale of 0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]. Higher scores indicate greater satisfaction with postoperative recovery. The total score ranges from 0 to 150; higher scores indicate greater satisfaction with postoperative recovery.
Time frame: Week 6
Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery
The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale (VAS) item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain. The SF-MPQ is administered on postoperative days 1 and 2.
Time frame: 48 Hours Post-Surgery (Day 2)
Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery
The SF-MPQ is a self-assessment of pain symptoms. The questionnaire includes 15 pain descriptor items that are ranked on a Likert scale from 0 (none) to 3 (severe); one Visual Analogue Scale item on which participants rank pain on a 10 cm VAS; and one Present Pain Intensity item on which participants rank their present pain on a Likert scale from 0 (no pain) to 5 (excruciating). The total score is the sum of responses and ranges from 0-60; lower scores indicate less pain.
Time frame: Week 6