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New treatment option for Cervical Spine Fusion
Official title Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
ClinicalTrials.gov ID: NCT05996133
What this study is testing
What is Bupivacaine Hcl 0.25% Inj?
Bupivacaine Hcl 0.25% Inj is an investigational medicine, being studied as a potential treatment for cervical spine fusion.
Also referred to as Dexamethasone, Epinephrine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Patients 40-80 years old, males and females, of any race and any ethnic group.
- Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
- Ability to speak and read English
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
You likely can't join if
- Emergency posterior CSFS.
- Revision surgery or history of previous cervical spine surgery
- History of allergy to local anesthetics or steroids.
- Patients who are coagulopathic at the time of surgery
- Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or...
- Infection at the site of the block.
See the full eligibility criteria
- Patients 40-80 years old, males and females, of any race and any ethnic group.
- Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
- Ability to speak and read English
- Patients with American Society of Anesthesiology (ASA) physical status score I- IV
- Emergency posterior CSFS.
- Revision surgery or history of previous cervical spine surgery
- History of allergy to local anesthetics or steroids.
- Patients who are coagulopathic at the time of surgery
- Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks
- Infection at the site of the block.
- Weight \< 40 kg to avoid local anesthetic toxicity.
- Patients on chronic or continuous opioid use of \> 50 MME (morphine milli-equivalent) per day for at least 30 days within 90 days prior to surgery.
- Patients with a history of chronic inflammatory conditions such as multiple sclerosis
- Refusal to participate or lack of providing the study consent
The study team makes the final eligibility decision.
Where it's taking place
- Hartford, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hartford, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.