Chronic Pain
Conditions
Brief summary
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.
Interventions
DRUGDexmedetomidine
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.
OTHERPlacebo Saline
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults who will undergo lumbar spinal fusion, including surgeries extending into thoracic and sacral segments * Subject is non-lactating and is either: * Not of childbearing potential * Of childbearing potential but is not pregnant at time of surgery as determined by pre-surgical pregnancy testing * Subject is ASA physical status 1, 2, or 3.
Exclusion criteria
* Subject is pregnant or breastfeeding * Any subject whom the investigators deem unable to complete any/all research related tasks * Subjects who are cognitively impaired (by history) * Subject requires antipsychotic medications * Subject has received treatment with alpha-2 agonists or antagonists within 2 weeks prior to surgery * Subject has known allergy to dexmedetomidine * Subjects with impaired renal or hepatic function * Subjects with advanced heart block * Subjects with severe ventricular dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents Used During the First 48 Hours Post-Surgery | Up to 48 Hours Post-Surgery (Day 2) | Amount of morphine administered during the 48 hours following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery | Week 6 | 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.' |
| Morphine Equivalents Used at 6 Weeks Post-Surgery | Up to Week 6 | Amount of morphine administered during the 6 weeks following surgery. |
| Number of Participants Requiring Pressor Use During Intraoperative Period | From beginning up to end of surgery (Day 0 - typically 1 to 3 hours) | 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). |
| Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery | Up to 48 Hours Post-Surgery (Day 2) | — |
| Length of PACU Stay | From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours) | — |
| Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery | 48 Hours Post-Surgery (Day 2) | 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.' |
| Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery | 48 Hours Post-Surgery (Day 2) | 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. |
| Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery | Week 6 | 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. |
| Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery | 48 Hours Post-Surgery (Day 2) | 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. |
| Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery | Week 6 | 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. |
| Length of Hospital Stay | From admission up to discharge (Up to 6 Weeks) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IV Dexmedetomidine Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Dexmedetomidine: 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. | 33 |
| Placebo saline placebo
Placebo Saline: 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. | 31 |
| Total | 64 |
Baseline characteristics
| Characteristic | Total | Placebo | IV Dexmedetomidine |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 9.9 | 59.9 years STANDARD_DEVIATION 10.8 | 63.2 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 29 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 52 Participants | 27 Participants | 25 Participants |
| Region of Enrollment United States | 64 participants | 31 participants | 33 participants |
| Sex: Female, Male Female | 35 Participants | 16 Participants | 19 Participants |
| Sex: Female, Male Male | 29 Participants | 15 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 33 | 0 / 31 |
| other Total, other adverse events | 1 / 33 | 2 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Dexmedetomidine | Morphine Equivalents Used During the First 48 Hours Post-Surgery | 180 morphine milligram equivalent (MME) |
| Placebo | Morphine Equivalents Used During the First 48 Hours Post-Surgery | 142.5 morphine milligram equivalent (MME) |
Secondary
Length of Hospital Stay
Time frame: From admission up to discharge (Up to 6 Weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Length of Hospital Stay | 5.89 Days | Standard Deviation 2.55 |
| Placebo | Length of Hospital Stay | 5.03 Days | Standard Deviation 2.42 |
Secondary
Length of PACU Stay
Time frame: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Length of PACU Stay | 172 minutes | Standard Deviation 90.24 |
| Placebo | Length of PACU Stay | 152 minutes | Standard Deviation 58.77 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery | 7.27 score on a scale | Standard Deviation 1.96 |
| Placebo | Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery | 6.53 score on a scale | Standard Deviation 2.12 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery | 90.73 score on a scale | Standard Deviation 16.72 |
| Placebo | Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery | 89.3 score on a scale | Standard Deviation 21.03 |
Secondary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery | 27.9 score on a scale | Standard Deviation 8.9 |
| Placebo | Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery | 25.5 score on a scale | Standard Deviation 10.7 |
Secondary
Morphine Equivalents Used at 6 Weeks Post-Surgery
Amount of morphine administered during the 6 weeks following surgery.
Time frame: Up to Week 6
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| IV Dexmedetomidine | Morphine Equivalents Used at 6 Weeks Post-Surgery | 0 morphine milligram equivalent (MME) |
| Placebo | Morphine Equivalents Used at 6 Weeks Post-Surgery | 0 morphine milligram equivalent (MME) |
Secondary
Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
Time frame: Up to 48 Hours Post-Surgery (Day 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Dexmedetomidine | Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery | 7 Participants |
| Placebo | Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery | 2 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IV Dexmedetomidine | Number of Participants Requiring Pressor Use During Intraoperative Period | 25 Participants |
| Placebo | Number of Participants Requiring Pressor Use During Intraoperative Period | 20 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery | 3 score on a scale | Standard Deviation 2.61 |
| Placebo | Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery | 3.26 score on a scale | Standard Deviation 2.53 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery | 115.5 score on a scale | Standard Deviation 16.91 |
| Placebo | Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery | 120.67 score on a scale | Standard Deviation 16.57 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IV Dexmedetomidine | Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery | 15.2 score on a scale | Standard Deviation 23.1 |
| Placebo | Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery | 12.2 score on a scale | Standard Deviation 11.4 |