MCP Block for Cervical Spine Fusion

(MCP Trial)

Overseen By Aseel Walker, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hartford Hospital

Must not be taking: Opioids

Disqualifiers: Emergency surgery, Previous spine surgery, Allergies, Coagulopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special nerve block, called the MCP block, can control pain more effectively than a placebo for individuals undergoing neck fusion surgery. The MCP block uses medications such as Bupivacaine (a local anesthetic), Dexamethasone (a corticosteroid), and Epinephrine (adrenaline). The trial will assess whether those receiving the MCP block experience less pain post-surgery compared to those receiving the placebo. Participants should be planning to undergo this specific neck surgery and must not have had previous neck surgery. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic or continuous opioid use of more than 50 MME per day, you may not be eligible to participate.

What is the safety track record for the MCP block treatment?

Research has shown that the MCP block, which combines Bupivacaine, Dexamethasone, and Epinephrine, is generally safe and well-tolerated. Studies have found that fascial plane blocks, like the MCP block, are effective and can be safely used in surgeries. This block has been used in neck spine surgeries with good results, managing pain without serious side effects.

Bupivacaine, a common numbing medicine, is widely accepted as safe when used in standard doses. Dexamethasone, a steroid, reduces swelling, while Epinephrine prolongs the numbing effect and reduces bleeding. Both are often used in medical procedures and are considered safe when used correctly.

In past experiences, patients receiving the MCP block for spine surgery reported effective pain relief without major problems. While minor side effects, such as temporary numbness or mild discomfort, might occur, serious issues are rare. This makes the MCP block a reliable option for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the MCP Block treatment for cervical spine fusion because it utilizes a novel delivery approach by targeting the multifidus cervicis plane directly. This method combines bupivacaine, dexamethasone, and epinephrine to potentially provide more precise pain relief and reduce inflammation post-surgery, compared to standard systemic pain medications and steroids. Unlike typical oral or intravenous options, this localized block could lead to fewer side effects and quicker recovery times, making it a promising alternative for patients undergoing cervical spine fusion.

What evidence suggests that the MCP block is effective for postoperative pain control in cervical spine fusion surgery?

Research has shown that the Multifidus Cervicis Plane (MCP) block, which participants in this trial may receive, effectively reduces pain after surgery. Studies have found that a mix of bupivacaine, dexamethasone, and epinephrine in the MCP block significantly lowers pain levels compared to not receiving this treatment. This method has also proven effective for other neck-related issues, such as headaches caused by neck problems. The MCP block targets specific nerves in the neck, helping to block pain signals. Overall, this combination provides better pain control and improves comfort for patients after neck surgeries. ^{1 2 3 4 5}

Who Is on the Research Team?

Pranjali Kainkaryam, MD

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

This trial is for patients aged 40-80 undergoing posterior cervical spine fusion surgery. They must be able to speak and read English, have an ASA score I-IV, and the surgery should be their first of this kind performed by a participating surgeon.

Inclusion Criteria

I am between 40 and 80 years old.

You have an ASA physical status score between I and IV.

I am scheduled for a specific spine surgery by a study surgeon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive preoperative bilateral MCP blocks or sham blocks on the back of their neck

1 day

1 visit (in-person)

Postoperative Monitoring

Participants' postoperative pain scores, opioid consumption, and other outcomes are monitored during hospitalization

Up to 72 hours

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including opioid use and satisfaction with pain management

2 weeks

1 visit (phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Dexamethasone
• Epinephrine
• Normal saline

Trial Overview The study tests if a Multifidus Cervicis Plane (MCP) block with Bupivacaine, Epinephrine, and Dexamethasone reduces pain more effectively than a sham saline injection in the first 24 hours after neck fusion surgery. It also looks at opioid use post-surgery, other painkillers needed, nausea/vomiting occurrences, hospital stay duration, safety of interventions, patient satisfaction with pain management and overall surgical experience.

How Is the Trial Designed?

Group I: MCP Block Experimental Treatment 1 Intervention

Bilateral Multifidus Cervicis plane block using 30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.

Group II: Sham Block Placebo Group 1 Intervention

Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

In a study of 435 patients, bupivacaine (0.75% in 8.25% dextrose) demonstrated superior efficacy compared to tetracaine for spinal anesthesia, with only one unsatisfactory anesthesia case in the bupivacaine group versus 19 in the tetracaine group for the lower dose.

Bupivacaine was found to be a safe and reliable option for spinal anesthesia, although tetracaine provided longer motor blockade; adding epinephrine to either anesthetic significantly extended their duration of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. Moore, DC.[2013]

In a study of 60 patients undergoing supraclavicular brachial plexus block, adding 8 mg of dexamethasone to levobupivacaine significantly prolonged the time until the first rescue analgesia was needed, from about 396 minutes to 706 minutes.

The combination of dexamethasone and levobupivacaine not only delayed the need for additional pain relief but also resulted in a faster onset and longer duration of both sensory and motor block compared to levobupivacaine alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical comparison between 0.5% levobupivacaine and 0.5% levobupivacaine with dexamethasone 8 mg combination in brachial plexus block by the supraclavicular approach. Pani, N., Routray, SS., Mishra, D., et al.[2022]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

Levobupivacaine demonstrated a greater vasodilatory effect compared to ropivacaine, as indicated by higher mean arterial pressure before the procedure and a larger drop in diastolic pressure during surgery.

Although levobupivacaine had a higher incidence of hypotension (19%) compared to ropivacaine (13%), the difference was not statistically significant, suggesting that ropivacaine may be the safer choice for cervical plexus block in patients undergoing carotid artery surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional anesthesia for carotid endarterectomy: a comparison between ropivacaine and levobupivacaine. Cristalli, A., Arlati, S., Bettinelli, L., et al.[2018]

In a study of 60 patients undergoing peripheral vascular surgery, spinal anesthesia using a mixture of tetracaine and bupivacaine provided a mean duration of approximately 300 minutes of effective anesthesia, with a 0% failure rate at doses of 15 mg and 12 mg.

The combination of these anesthetics resulted in no significant adverse effects, such as cerebrovascular or neurologic events, indicating that this technique is safe and effective for prolonged surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal anesthesia using a 1:1 mixture of bupivacaine and tetracaine for peripheral vascular surgery. Hoff, BH., Fletcher, SJ., Rickford, WJ., et al.[2019]

In a study of 60 first-time mothers, adding dexamethasone to epidural levobupivacaine significantly prolonged the duration of pain relief during labor, indicating enhanced efficacy of the analgesic regimen.

The combination of dexamethasone and levobupivacaine also resulted in lower total consumption of levobupivacaine without increasing risks for maternal or neonatal complications, suggesting a safer and more effective approach to labor analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural levobupivacaine versus a combination of levobupivacaine and dexamethasone in patients receiving epidural analgesia. Wahdan, AS., El-Sakka, AI., Hassan, AR., et al.[2022]

In a study of 100 women undergoing elective cesarean sections, spinal anesthesia with 10 mg of plain levobupivacaine or 15 mg of plain ropivacaine provided comparable anesthesia to 10 mg of hyperbaric bupivacaine, indicating similar efficacy among these agents.

While the onset of motor block was significantly slower for ropivacaine compared to bupivacaine, there were no significant differences in sensory block duration, recovery times, or side effects among the three groups, suggesting safety across the different anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised Control Trial Comparing Plain Levobupivacaine and Ropivacaine with Hyperbaric Bupivacaine in Caesarean Deliveries. Sethi, D.[2022]

Adding epinephrine (EPI) to bupivacaine (BUP) for superficial cervical plexus blockade (SCPB) significantly lowers plasma BUP concentrations, especially when using a lower concentration of BUP (0.25%).

The addition of EPI does not lead to increased heart rate or cardiac arrhythmias, indicating that it is a safe adjunct in this procedure without adverse cardiac effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma bupivacaine concentrations and effects of epinephrine after superficial cervical plexus blockade in patients undergoing carotid endarterectomy. Harwood, TN., Butterworth, JF., Colonna, DM., et al.[2019]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05996133

NCT05996133 | Multifidus Cervicis Plane Block Vs. Sham ... 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 ...

2. withpower.com withpower.com/trial/phase-4-cervical-spine-fusion-11-2023-e7aa0?fbclid=IwZXh0bgNhZW0CMTEAAR41LGCKq1Mxfg-1z5MxcjFMmn96d5r8iGOLhAwMofQrdRX8gVlU0_N4auk8Dw_aem_98KQobq6BV_xDojI15qr8w

MCP Block for Cervical Spine Fusion (MCP Trial) Trial Overview The study tests if a Multifidus Cervicis Plane (MCP) block with Bupivacaine, Epinephrine, and Dexamethasone reduces pain more effectively than a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007856/

Fascial plane blocks as the main anesthetic method This narrative review evaluates the efficacy of fascial plane blocks (FPB) as sole anesthetic method for surgery.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06083298?cond=Cervical%20vertebrae&aggFilters=status:not%20rec%20ava&viewType=Table&rank=6

Multifidus Cervicis and Inter-Semispinal Plane Blocks in ... Furthermore, MCP block was effective in another study as a treatment for cervicogenic headaches. ... Multifidus cervicis plane block is effective for cervical ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8577706/

Emerging options for analgesia in posterior cervical spine ... Here we describe our experience with the multifidus cervicis plane (MCP) block in a case of posterior cervical spine surgery.