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NCT05996133 · ClinicalTrials.gov registry record · Phase 4
Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
A Phase 4 study of Cervical Spine Fusion, sponsored by Hartford Hospital.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05996133: Recruiting Phase 4 study of Cervical Spine Fusion, sponsored by Hartford Hospital.
NCT05996133 is a Phase 4 study of Cervical Spine Fusion that is actively recruiting participants, run by Hartford Hospital. The registered enrollment target is 38 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05996133, a Phase 4 study of Cervical Spine Fusion, is actively recruiting participants, sponsored by Hartford Hospital.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The maximum pain score for the past 24 postoperative hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants using the validated tool; Brief Pain Inventory-Short Form.
Conditions Studied
Interventions
- OTHER Normal saline
- DRUG Bupivacaine Hcl 0.25% Inj
Study Locations (1)
Connecticut
- Hartford Hospital - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-12-12 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 4 |
What NCT05996133 shows while recruiting
NCT05996133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Cervical Spine Fusion appearing as the primary indexed condition, and to 2 interventions - of which Normal saline is the first listed.
NCT05996133 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05996133 about?
NCT05996133 is a clinical study titled "Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery". 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 t...
What is the current status of trial NCT05996133?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2023-12-12. Estimated completion is 2027-06-30.
What conditions does trial NCT05996133 study?
This clinical trial studies the following conditions: Cervical Spine Fusion.
What interventions are being tested in trial NCT05996133?
The interventions under investigation include: Normal saline (OTHER), Bupivacaine Hcl 0.25% Inj (DRUG).
Who is sponsoring clinical trial NCT05996133?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05996133 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05996133's enrollment target sits among peer trials
38 1476th of 2000 higher than 520 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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