Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335517
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2006-06-08
Brief Title:
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DepoDur
Brief Summary:
The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery The study will also assess the safety of this drug in this patient population
Detailed Description:
Patients will be recruited from the general practices of Drs Rechtine Rubery Molinari and Zeidman An epidural catheter will be placed under direct vision at the conclusion of surgery The catheter will be advanced at least 4 cm to L1 level prior to injection Two milliliters of air will be injected through the catheter to ensure patency Aspiration will then be done to ensure no intradural injections Then the undiluted 1 or 15 cc DepoDurTM will be injected
The type of surgery will be recorded as to
1 The number of levels of surgery
2 The number of levels fused
3 The number of levels instrumented
4 The number of levels with an interbody fusion
5 Time to ambulate
6 Time to use oral analgesics
7 The time of DepoDur injection
8 The amount of pain medications used in the 0-2 hour time interval after injection 2-4 hours and each subsequent 4 hour interval
9 Pain scores will be recorded with vital signs The pain score is from 1 to 10 and is asked orally to patients This is part of the standard of care
In a one-to-one randomization patients will receive either a 10 or 15 mg dose of DepoDur at the time of surgery
Each patient will be provided with a morphine PCA patient controlled analgesia system postoperatively and then oral analgesics as appropriate Analgesic requirements in morphine equivalents will be recorded Comparison between the 10 and 15 mg dose will be done as to analgesic effectiveness and safety
Post-operative orders for 48 hours will include epidural narcotic protocol to include The following post-operative orders are standard of care
1 Patients bedside and chart will be identified as spinal narcotic
2 Head of bed maintained at 30 degrees of elevation
3 04 mg of Narcan naloxone will be added to each liter of IV fluid
4 Counted respirations and pupil size to be included with vital signs
5 Pain scores with vital signs The pain score is from 1 to 10 and is asked orally to patients This is part of the standard of care
6 Continuous pulse oxymetry measurement
7 Call House officer for respiratory rate of 8 minute or changes in saturation as measured by pulse oxymetry
Current post-operative PCA orders usually start with 1 mg of morphine per cc with a seven to ten minute lockout Based on work by Rawal 2-3 who demonstrated that small doses of Naloxone could help eliminate nuisance side effects of epidural narcotics such as localized pruritis 04 mg of Naloxon will be added to each liter of IV fluid Continuous pulse oxymetry should be used to monitor the patients respiratory function for 48 hours after the last dose of the epidural narcotic Post-operative vital signs will be obtained in the recovery room by anesthesia policy Once the patient is transferred to the floor vital signs would be obtained every hour for the first four hours and every four hours after that
The standard of care involves providing patients after lumbar surgery with the best pain relief possible This can be done in a number of different ways The use of Duramorph has been possible for many years It has not been used recently only because of the need to re-dose The pain relief provided by the epidural narcotic is detailed in the literature What will be altered through this study is the addition of the long acting epidural narcotic DepoDur This will potentially provide for sustained pain relief for 48 hours Usually by 48 hours postoperatively the patient is starting to improve to a point of being able to be maintained on oral analgesics The remainder of the study is consistent with standard of care for epidural narcotics
The type of surgery will be recorded as to
1 The number of levels of surgery
2 The number of levels fused
3 The number of levels instrumented
4 The number of levels with an interbody fusion
5 Time to ambulate
6 Time to use oral analgesics
7 The time of DepoDur injection
8 The amount of pain medications used in the 0-2 hour time interval after injection 2-4 hours and each subsequent 4 hour interval
9 Pain scores will be recorded with vital signs The pain score is from 1 to 10 and is asked orally to patients This is part of the standard of care
In a one-to-one randomization patients will receive either a 10 or 15 mg dose of DepoDur at the time of surgery
Each patient will be provided with a morphine PCA patient controlled analgesia system postoperatively and then oral analgesics as appropriate Analgesic requirements in morphine equivalents will be recorded Comparison between the 10 and 15 mg dose will be done as to analgesic effectiveness and safety
Post-operative orders for 48 hours will include epidural narcotic protocol to include The following post-operative orders are standard of care
1 Patients bedside and chart will be identified as spinal narcotic
2 Head of bed maintained at 30 degrees of elevation
3 04 mg of Narcan naloxone will be added to each liter of IV fluid
4 Counted respirations and pupil size to be included with vital signs
5 Pain scores with vital signs The pain score is from 1 to 10 and is asked orally to patients This is part of the standard of care
6 Continuous pulse oxymetry measurement
7 Call House officer for respiratory rate of 8 minute or changes in saturation as measured by pulse oxymetry
Current post-operative PCA orders usually start with 1 mg of morphine per cc with a seven to ten minute lockout Based on work by Rawal 2-3 who demonstrated that small doses of Naloxone could help eliminate nuisance side effects of epidural narcotics such as localized pruritis 04 mg of Naloxon will be added to each liter of IV fluid Continuous pulse oxymetry should be used to monitor the patients respiratory function for 48 hours after the last dose of the epidural narcotic Post-operative vital signs will be obtained in the recovery room by anesthesia policy Once the patient is transferred to the floor vital signs would be obtained every hour for the first four hours and every four hours after that
The standard of care involves providing patients after lumbar surgery with the best pain relief possible This can be done in a number of different ways The use of Duramorph has been possible for many years It has not been used recently only because of the need to re-dose The pain relief provided by the epidural narcotic is detailed in the literature What will be altered through this study is the addition of the long acting epidural narcotic DepoDur This will potentially provide for sustained pain relief for 48 hours Usually by 48 hours postoperatively the patient is starting to improve to a point of being able to be maintained on oral analgesics The remainder of the study is consistent with standard of care for epidural narcotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None