Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996133
Status:
RECRUITING
Last Update Posted:
2023-12-19
First Post:
2023-07-26
Brief Title:
Multifidus Cervicis Plane Block Vs Sham Block For Posterior Cervical Spine Fusion Surgery
Sponsor:
Hartford Hospital
Organization:
Hartford Hospital
Study Overview
Official Title:
MCP Study A Double-Blinded Randomized Controlled Trial To Compare Multifidus Cervicis Plane Block MCP Vs Sham Block In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery CSFS
Status:
RECRUITING
Status Verified Date:
2023-12
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:
MCP
Brief Summary:
The goal of this randomized double-blinded clinical trial is to assess the benefit of administering a Multifidus Cervicis Plane MCP block compared to a sham block as a method of postoperative pain control in patients undergoing posterior cervical spine fusion surgery The main question it aims to answer is if the MCP block group will have reduced maximum pain scores during the first 24 postoperative hours compared to the sham block group
Participants will receive preoperative bilateral MCP blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mLs 025 Bupivacaine 05 mL 5 mg preservative-free Dexamethasone 01 mL Epinephrine MCP block group Researchers will compare the MCP block to the preoperative sham block which consists of injecting 3 mL of normal saline into the same area Sham block group to compare the postoperative pain scores between the groups as a main objective The secondary objectives are
Postoperative opioid consumption during hospitalization and at 2 weeks after discharge
The amount and type of non-opioid analgesics used during hospitalization
The occurrence of postoperative nausea and vomiting PONV and the use of antiemetics
Hospital and Post Anesthesia Care Unit length of stay LOS
Monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge
Patient satisfaction with pain management and overall satisfaction with the surgery experience
Participants will receive preoperative bilateral MCP blocks on the back of their neck using the standard of care local anesthetic solution that consists of 30 mLs 025 Bupivacaine 05 mL 5 mg preservative-free Dexamethasone 01 mL Epinephrine MCP block group Researchers will compare the MCP block to the preoperative sham block which consists of injecting 3 mL of normal saline into the same area Sham block group to compare the postoperative pain scores between the groups as a main objective The secondary objectives are
Postoperative opioid consumption during hospitalization and at 2 weeks after discharge
The amount and type of non-opioid analgesics used during hospitalization
The occurrence of postoperative nausea and vomiting PONV and the use of antiemetics
Hospital and Post Anesthesia Care Unit length of stay LOS
Monitor the safety of the study interventions during hospitalization and readmissions within 30 days of discharge
Patient satisfaction with pain management and overall satisfaction with the surgery experience
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None