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NCT Number: NCT03325972

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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 saline

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Mean Numeric Pain Rating Scale (NRS) Scores During the First 48 Hours Post-Surgery

    Time frame: 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.'

  2. Numeric Pain Rating Scale (NPRS) Score at 6 Weeks Post-Surgery

    Time frame: 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.'

  3. Morphine Equivalents Used at 6 Weeks Post-Surgery

    Time frame: Up to Week 6

    Amount of morphine administered during the 6 weeks following surgery.

  4. 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)

    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).

  5. Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery

    Time frame: Up to 48 Hours Post-Surgery (Day 2)

  6. Length of PACU Stay

    Time frame: From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)

  7. Length of Hospital Stay

    Time frame: From admission up to discharge (Up to 6 Weeks)

  8. Mean Quality of Recovery After Anesthesia (QoR-15) Scores During the First 48 Hours Post-Surgery

    Time frame: 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.

  9. Quality of Recovery After Anesthesia (QoR-15) Score at 6 Weeks Post-Surgery

    Time frame: 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.

  10. Mean Short-Form McGill Pain Questionnaire (SF-MPQ) Scores During First 48 Hours Post-Surgery

    Time frame: 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.

  11. Short-Form McGill Pain Questionnaire (SF-MPQ) Scores at 6 Weeks Post-Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled Study on the Effects of Intravenous Dexmedetomidine on Pain in Patients Undergoing Elective Spinal Surgery

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2017
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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