Ignite Creation Date:
2024-05-06 @ 2:08 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04220489
Status:
TERMINATED
Last Update Posted:
2024-01-30
First Post:
2019-11-21
Brief Title:
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
Sponsor:
Jacques E Chelly
Organization:
University of Pittsburgh
Study Overview
Official Title:
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery A Randomized Double-blind Placebo-controlled Trial
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to unexpected issues surrounding the 2020 COVID-19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate NMDA receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in chronic back pain patients undergoing spinal laminectomyfusion when compared to placebo
Opioid dependence will be defined as daily opioid use 2 or more doses per day for a period of two-months or longer Intraoperatively patients will receive a 1 mgkg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia Thereafter a continuous infusion of 020 mgkghr ketamine with a maximum dose of 20 mghr or saline will be run to conclude at 24 hours after the end of the surgery fascial closure The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively Secondary outcome measures will be VAS pain scores at rest and with movement in PACU 24 hr 48 hr 72 hr 2 week post-op visit 6 week follow-up visit as well as McGill Pain Questionnaire Pain Catastrophizing Scale and emotional distress surveys assessing depression and anxiety at preopscreening postop and 6 week follow-up PROMIS Emotional Distress-Anxiety Short Form PROMIS Emotional Distress-Depression Short Form as well as a Neuro-QOL Short Form v11 - Satisfaction with Social Roles and Activities
Opioid dependence will be defined as daily opioid use 2 or more doses per day for a period of two-months or longer Intraoperatively patients will receive a 1 mgkg dose of intravenous ketamine or saline with 15 minutes after induction of general anesthesia Thereafter a continuous infusion of 020 mgkghr ketamine with a maximum dose of 20 mghr or saline will be run to conclude at 24 hours after the end of the surgery fascial closure The primary outcome measure will be hydromorphone PCA usage during the first 72 hours postoperatively Secondary outcome measures will be VAS pain scores at rest and with movement in PACU 24 hr 48 hr 72 hr 2 week post-op visit 6 week follow-up visit as well as McGill Pain Questionnaire Pain Catastrophizing Scale and emotional distress surveys assessing depression and anxiety at preopscreening postop and 6 week follow-up PROMIS Emotional Distress-Anxiety Short Form PROMIS Emotional Distress-Depression Short Form as well as a Neuro-QOL Short Form v11 - Satisfaction with Social Roles and Activities
Detailed Description:
Patients will be recruited from the University of Pittsburgh Medical Center UPMC Neurosurgery Clinic and Operating Room Schedule The primary surgeon will identify patients who would be eligible for inclusion ask them if they would be interested in participating and if so the enrollment and consent process would be initiated The participating neurosurgeons include Dr Okonkwo and Dr Hamilton who have agreed to allow us access to their patients Informed consent will be performed by the surgeon or the PI Enrollment will be performed by the study coordinator andor trained representative from the Acute Interventional Perioperative Pain Service AIPPS Enrollment will include review of eligibility and detailed explanation of the study
Screening Visit
After patients are enrolled into the study at the preoperative neurosurgery clinic a number of forms will be filled out by the participants McGill Pain questionaire-Short form pain medication review form and the Pain Catastrophizing Scale PCS Sullivan 1995 PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed
Pre-Operative Visit
The participant will be asked to come into the Aiken Medical Building Suite 407 on a date after the clinic visit but before their day of surgery for a Pre-Operative Visit Investigators will work with the participant to determine their opioid dose regimen and the participant will be asked to come into the Aiken Medical Building thirty minutes before their opioid dose is due and will be asked to bring with them their upcoming dose of pain medication Prior to taking their pain medication the participant will then be administered a cold-pressor pain sensitivity test Heart rate and blood pressure will be recorded before and after the cold-pressor test Once the cold pressor test is completed the McGill Pain Questionnaire will be administered After this questionnaire is complete the participant will take the dose of opioid medication they have brought from home and are scheduled to receive and will wait in the clinic for 30 minutes for the pain medication to take effect Once the 30 minutes is complete the cold-pressor test will be repeated heart rate and blood pressure collected before and after and McGill Pain Questionnaire will be administered again
Surgical Visit
At the day of surgery participants will be seen by team members of the Acute Interventional Perioperative Pain Service preoperatively Patients will be randomized into the Ketamine Group or the Placebo Group
A standardized general anesthesia protocol will be used by the hands-on provider All drugs used intraoperatively including total hydromorphone dose will be collected from the electronic chart
The amount of narcotics and non-narcotic analgesics administered in the operative and postoperative period will be collected from the electronic chart from day of surgery until discharge Visual Analogue Scale VAS pain scores will be collected
Post-Op Visit
Patients will follow-up at Neurosurgery clinic at 10-14 days postoperatively At this time daily opioid usage will be assessed and converted to morphine equivalents24 hr At this visit pain medication review form and the Pain Catastrophizing Scale PCS Sullivan 1995 PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed by the participant
6-Week Follow-Up Visit
The participant will be asked to come to the Aiken Medical Building Suite 407 approximately 6 weeks after their surgery Investigators will work with the participant to determine their post-operative opioid dose regimen Prior to taking their pain medication the participant will then be administered a cold-pressor pain sensitivity test in a manner identical to that use during the pre-operative assessmentIn addition to the McGill Pain Questionnaire-Short form a pain medication review form the Pain Catastrophizing Scale PCS Sullivan 1995 the PROMIS Emotional Distress-Anxiety Short Form the PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed
Screening Visit
After patients are enrolled into the study at the preoperative neurosurgery clinic a number of forms will be filled out by the participants McGill Pain questionaire-Short form pain medication review form and the Pain Catastrophizing Scale PCS Sullivan 1995 PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed
Pre-Operative Visit
The participant will be asked to come into the Aiken Medical Building Suite 407 on a date after the clinic visit but before their day of surgery for a Pre-Operative Visit Investigators will work with the participant to determine their opioid dose regimen and the participant will be asked to come into the Aiken Medical Building thirty minutes before their opioid dose is due and will be asked to bring with them their upcoming dose of pain medication Prior to taking their pain medication the participant will then be administered a cold-pressor pain sensitivity test Heart rate and blood pressure will be recorded before and after the cold-pressor test Once the cold pressor test is completed the McGill Pain Questionnaire will be administered After this questionnaire is complete the participant will take the dose of opioid medication they have brought from home and are scheduled to receive and will wait in the clinic for 30 minutes for the pain medication to take effect Once the 30 minutes is complete the cold-pressor test will be repeated heart rate and blood pressure collected before and after and McGill Pain Questionnaire will be administered again
Surgical Visit
At the day of surgery participants will be seen by team members of the Acute Interventional Perioperative Pain Service preoperatively Patients will be randomized into the Ketamine Group or the Placebo Group
A standardized general anesthesia protocol will be used by the hands-on provider All drugs used intraoperatively including total hydromorphone dose will be collected from the electronic chart
The amount of narcotics and non-narcotic analgesics administered in the operative and postoperative period will be collected from the electronic chart from day of surgery until discharge Visual Analogue Scale VAS pain scores will be collected
Post-Op Visit
Patients will follow-up at Neurosurgery clinic at 10-14 days postoperatively At this time daily opioid usage will be assessed and converted to morphine equivalents24 hr At this visit pain medication review form and the Pain Catastrophizing Scale PCS Sullivan 1995 PROMIS Emotional Distress-Anxiety Short Form and PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed by the participant
6-Week Follow-Up Visit
The participant will be asked to come to the Aiken Medical Building Suite 407 approximately 6 weeks after their surgery Investigators will work with the participant to determine their post-operative opioid dose regimen Prior to taking their pain medication the participant will then be administered a cold-pressor pain sensitivity test in a manner identical to that use during the pre-operative assessmentIn addition to the McGill Pain Questionnaire-Short form a pain medication review form the Pain Catastrophizing Scale PCS Sullivan 1995 the PROMIS Emotional Distress-Anxiety Short Form the PROMIS Emotional Distress-Depression Short Form Brief Psychiatric Rating Scale and Neuro-QoL Short Form v11 - Satisfaction with Social Roles and Activities will also be completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None