Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 2:28 AM
Study NCT ID:
NCT06447194
Status:
WITHDRAWN
Last Update Posted:
2025-07-31
First Post:
2024-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of RECK in Posterior Spinal Fusion
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
Effect of Local Injectable Ropivacaine, Epinephrine, Clonidine, and Ketorolac (RECK) Anesthetic Cocktail on Postoperative Pain in Posterior Spinal Fusion
Status:
WITHDRAWN
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was not feasible due to logistical and implementation challenges. No participants were enrolled and the study will not proceed further.
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, 0.25 mg epinephrine, 0.04 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:
True
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?: