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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05996133
The ClinicalTrials.gov registry entry for NCT05996133 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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