Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-31 @ 2:47 PM
Study NCT ID:
NCT05996133
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
Sponsor:
Hartford Hospital
Organization:
Study Overview
Official Title:
Comparing Multifidus Cervicis Plane Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery
Status:
RECRUITING
Status Verified Date:
2025-08
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 0.25% Bupivacaine + 0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 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 0.25% Bupivacaine + 0.5 mL (5 mg) preservative-free Dexamethasone + 0.1 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:
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?:
True
Is an FDA AA801 Violation?: