MCP Block for Cervical Spine Fusion

(MCP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Pranjali Kainkaryam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Hartford Hospital

Must not be taking: Opioids

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the drug used in the MCP Block for Cervical Spine Fusion?

Research shows that bupivacaine, when used with epinephrine, is a reliable local anesthetic that prolongs the duration of pain relief. Additionally, dexamethasone, when combined with local anesthetics like bupivacaine, can enhance pain relief by reducing inflammation. ^{1 2 3 4 5}

Is the MCP Block for Cervical Spine Fusion safe for humans?

Bupivacaine (Marcaine), used in various procedures, is generally safe with minimal side effects when used correctly. In a review of 11,080 cases, only 15 systemic toxic reactions occurred, all without lasting harm. Additionally, when used in obstetrics, it showed minimal side effects on mothers and newborns. ^{1 2 4 6 7}

How does the MCP Block treatment for cervical spine fusion differ from other treatments?

The MCP Block treatment for cervical spine fusion is unique because it likely involves a specific type of regional anesthesia, such as a cervical plexus block, which may use drugs like bupivacaine or ropivacaine. These drugs are known for their effectiveness in providing localized pain relief and may be combined with epinephrine to enhance their duration and reduce side effects like low blood pressure. ^{1 2 3 8 9}

Research Team

Pranjali Kainkaryam, MD

Principal Investigator

Hartford Hospital

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic)
• Dexamethasone (Corticosteroid)
• Epinephrine (Vasoconstrictor)
• Normal saline (Placebo)

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.

Participant Groups

Group I: MCP Block Experimental Treatment 3 Interventions

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+

Dr. Ajay Kumar

Hartford Hospital

Chief Medical Officer since 2016

MD, University of Connecticut School of Medicine

Jeffrey A. Flaks

Hartford Hospital

Chief Executive Officer since 2019

Master's in Health Administration, George Washington University

Findings from Research

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Spinal anesthesia: bupivacaine compared with tetracaine. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Spinal anesthesia using a 1:1 mixture of bupivacaine and tetracaine for peripheral vascular surgery. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Plasma bupivacaine concentrations and effects of epinephrine after superficial cervical plexus blockade in patients undergoing carotid endarterectomy. [2019]

4. India 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. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Epidural levobupivacaine versus a combination of levobupivacaine and dexamethasone in patients receiving epidural analgesia. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

8. Turkey pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

Regional anesthesia for carotid endarterectomy: a comparison between ropivacaine and levobupivacaine. [2018]