Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559969
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
IV vs Epidural Opioids Epidural Local Anesthetic for Laparotomy Analgesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to determine if the two common ways of administering additional opioids morphine like substance narcotic with an epidural either mixed in the epidural solution or given separately through the intravenous are equally effective in controlling post-operative pain
Detailed Description:
Open label observer and patient blinded randomized control study of patients age 18 to 85 who are booked to have an open upper abdominal surgical incision where an epidural would normally be offered and expected to be used for an average of 4 to 5 days
Study will be done at University of Iowa Hospitals and Clinics main operating room and post-operative surgical wards
Eligible patients who choose to consent to participate in the study will be randomized to either have the opioid administered intravenously using patient controlled administration PCA device along with a local anesthetic only continuous epidural infusion the control group or to the treatment group of the opioid combined with the local anesthetic in the epidural with a continuous infusion combined with patient controlled epidural administered PCEA bolus The epidural pump along with the PCA machine will be placed in such away that they can be obscured by a removable cover The patient will be seen daily to obtain pain and satisfaction scores using the Quality of Recovery QoR 15 Secondary data will also be collected including presence of side effects ability to mobilize signs of return of bowel function need for supplemental oxygen and total amount of opioid required Patients will be assigned a study number which all data will be kept under
Study will be done at University of Iowa Hospitals and Clinics main operating room and post-operative surgical wards
Eligible patients who choose to consent to participate in the study will be randomized to either have the opioid administered intravenously using patient controlled administration PCA device along with a local anesthetic only continuous epidural infusion the control group or to the treatment group of the opioid combined with the local anesthetic in the epidural with a continuous infusion combined with patient controlled epidural administered PCEA bolus The epidural pump along with the PCA machine will be placed in such away that they can be obscured by a removable cover The patient will be seen daily to obtain pain and satisfaction scores using the Quality of Recovery QoR 15 Secondary data will also be collected including presence of side effects ability to mobilize signs of return of bowel function need for supplemental oxygen and total amount of opioid required Patients will be assigned a study number which all data will be kept under
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