Back to resultsStudy on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo Saline
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IV dexmedetomidine
Placebo
Arm Description
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
saline placebo
Outcomes
Primary Outcome Measures
Morphine Equivalents Used During the First 48 Hours Post-Surgery
Amount of morphine administered during the 48 hours following surgery.
Secondary Outcome Measures
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.'
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.'
Morphine Equivalents Used at 6 Weeks Post-Surgery
Amount of morphine administered during the 6 weeks following surgery.
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).
Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
Length of PACU Stay
Length of Hospital Stay
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03325972
Brief Title
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Official Title
Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
February 22, 2022 (Actual)
Study Completion Date
February 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
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.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IV dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
saline placebo
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine Equivalents Used During the First 48 Hours Post-Surgery
Description
Amount of morphine administered during the 48 hours following surgery.
Time Frame
Up to 48 Hours Post-Surgery (Day 2)
Secondary Outcome Measure Information:
Title
Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery
Description
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)
Title
Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery
Description
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
Title
Morphine Equivalents Used at 6 Weeks Post-Surgery
Description
Amount of morphine administered during the 6 weeks following surgery.
Time Frame
Up to Week 6
Title
Number of Participants Requiring Pressor Use During Intraoperative Period
Description
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)
Title
Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery
Time Frame
Up to 48 Hours Post-Surgery (Day 2)
Title
Length of PACU Stay
Time Frame
From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
Title
Length of Hospital Stay
Time Frame
From admission up to discharge (Up to 6 Weeks)
Title
Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery
Description
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)
Title
Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery
Description
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
Title
Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery
Description
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)
Title
Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Doan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
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