Chronic PainPhase 4NCT03325972
Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
A Phase 4 study testing Dexmedetomidine in people with Chronic Pain, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2016to 22 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Subjects with impaired renal or hepatic function
- Subjects with advanced heart block
- Subjects with severe ventricular dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
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.
- Conditions
- Chronic Pain
- Being tested
- Dexmedetomidine, Placebo Saline
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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 SalineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IV dexmedetomidine | Experimental | Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | saline placebo Receives: Other: Placebo Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalents Used During the First 48 Hours Post-Surgery
Amount of morphine administered during the 48 hours following surgery.
Measured: Up to 48 Hours Post-Surgery (Day 2)
Secondary outcomes (11)
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.'
Measured: 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.'
Measured: Week 6
Morphine Equivalents Used at 6 Weeks Post-Surgery
Amount of morphine administered during the 6 weeks following surgery.
Measured: 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).
Measured: 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
Measured: Up to 48 Hours Post-Surgery (Day 2)
Length of PACU Stay
Measured: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
Length of Hospital Stay
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start14 Sep 2016
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa Doan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325972
- Sponsor's protocol ID
- 14-00915
- Status last verified
- May 2023
- First submitted
- 26 Oct 2017
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery
- ClinicalTrials.gov ID
- NCT03325972
- Acronym / sponsor ID
- 14-00915
- Conditions
- Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Posted 21 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics. |
| Placebo | Placebo comparator | Other: Placebo Salinesaline placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineThe 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. | Drug | IV dexmedetomidine |
| Placebo SalinePlacebo 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. | Other | Placebo |
Primary outcome
Morphine Equivalents Used During the First 48 Hours Post-Surgery
Time frame: Up to 48 Hours Post-Surgery (Day 2)
Amount of morphine administered during the 48 hours following surgery.
11 secondary outcomes
Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery
Time frame: 48 Hours Post-Surgery (Day 2)
Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery
Time frame: Week 6
Morphine Equivalents Used at 6 Weeks Post-Surgery
Time frame: Up to Week 6
Number of Participants Requiring Pressor Use During Intraoperative Period
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
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
Time frame: 48 Hours Post-Surgery (Day 2)
Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery
Time frame: Week 6
Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery
Time frame: 48 Hours Post-Surgery (Day 2)
Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Doan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Chronic Pain, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Equivalents Used During the First 48 Hours Post-Surgery (time frame: Up to 48 Hours Post-Surgery (Day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.