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Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery

Study acronym: MCP
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date: Dec 30, 2024 to Dec 30, 2026
    • Study completion date: Jun 30, 2025 to Jun 30, 2027
    • Interventions: Bupivacain (Drug), Dexamethasone (Drug), Epinephrine (Drug), Normal saline (Drug) to Bupivacaine Hcl 0.25% Inj (Drug), Normal saline (Other)
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2024 to Dec 30, 2024
    • Study completion date: Jun 1, 2025 to Jun 30, 2025
    • Start date changed from estimate of Dec 1, 2023 to Dec 12, 2023
  3. Minor Interventions: Bupivacaine HCL (Drug), Dexamethasone (Drug), Epinephrine (Drug), Normal saline (Drug) to Bupivacain (Drug), Dexamethasone (Drug), Epinephrine (Drug), Normal saline (Drug)
    • Eligibility criteria expanded, about 4 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05996133
Lead Sponsor Hartford Hospital
Conditions
(from sponsor)
Cervical Spine Fusion
Related terms Klippel-Feil Syndrome
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov