Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Placebo Saline

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV dexmedetomidine; Dexmedetomidine is an alpha-2-adrenergic agonist. It is commonly used for sedation and as an adjunct to general anesthetics.	Drug: 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.
Placebo Comparator: Placebo; saline placebo	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine Equivalents Used During the First 48 Hours Post-Surgery	Amount of morphine administered during the 48 hours following surgery.	Up to 48 Hours Post-Surgery (Day 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.'	Week 6
Morphine Equivalents Used at 6 Weeks Post-Surgery	Amount of morphine administered during the 6 weeks following surgery.	Up to Week 6
Length of PACU Stay		From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
Length of Hospital Stay		From admission up to discharge (Up to 6 Weeks)
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.	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).	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		Up to 48 Hours Post-Surgery (Day 2)
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.	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.	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.	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.'	48 Hours Post-Surgery (Day 2)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Lisa Doan, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Actual): February 22, 2022
• Study Completion (Actual): February 22, 2022

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 14-00915

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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