Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-14
Brief Title:
Effect of RECK in Posterior Spinal Fusion
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effect of Local Injectable Ropivacaine Epinephrine Clonidine and Ketorolac RECK Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
RECK is a combination of local anesthesia medications used for the purpose of pain control RECK is an acronym which stands for Ropivacaine Epinephrine Clonidine and Ketorolac The purpose of this study is to investigate the effect of RECK local injectable anesthetic in the setting of posterior spinal fusion Our specific aims are the following
Primary aim to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores
Secondary aims to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay
Hypothesis RECK injection will significantly decrease postoperative VAS pain score opioid consumption and hospital length of stay compared to placebo controls
Primary aim to investigate the effect of RECK local injectable anesthetic on postoperative VAS pain scores
Secondary aims to investigate of effect of RECK injection on postoperative opioid consumption and hospital length of stay
Hypothesis RECK injection will significantly decrease postoperative VAS pain score opioid consumption and hospital length of stay compared to placebo controls
Detailed Description:
Patients will be randomized into two groups Intraoperatively they will be given either 1 a 50 mL RECK ropivacaine epinephrine clonidine and ketorolac cocktail containing 123 mg ropivacaine 025 mg epinephrine 004 mg clonidine and 15 mg ketorolac into the paraspinal musculature and subdermal space surrounding the operative site once the fascia is closed intervention group or 2 a 50 mL injection of saline control group RECK is used for pain control and will be administered by fellowship-trained orthopaedic spine surgeons All patients will have a patient-controlled analgesia pump initiated shortly after surgery with routine postoperative care and observation from nurses pain management and orthopedic surgeons and residents
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?:
False
Is an FDA AA801 Violation?:
None