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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325972
• Other study ID #: 14-00915
• Status: Completed
• Phase: Phase 4
• Start date: September 14, 2016
• Est. completion date: February 22, 2022

Study information

• Verified date: May 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 22, 2022
• Est. primary completion date: February 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
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.'	Week 6
Secondary	Morphine Equivalents Used at 6 Weeks Post-Surgery	Amount of morphine administered during the 6 weeks following surgery.	Up to Week 6
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).	From beginning up to end of surgery (Day 0 - typically 1 to 3 hours)
Secondary	Number of Participants Requiring Pressor Use During First 48-Hours Post-Surgery		Up to 48 Hours Post-Surgery (Day 2)
Secondary	Length of PACU Stay		From PACU admission up to end of PACU stay (Day 0 - typically 1 to 3 hours)
Secondary	Length of Hospital Stay		From admission up to discharge (Up to 6 Weeks)
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.	48 Hours Post-Surgery (Day 2)
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.	Week 6
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.	48 Hours Post-Surgery (Day 2)
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.	Week 6