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MCP Block for Cervical Spine Fusion (MCP Trial)

Phase 4
Recruiting
Led By Pranjali Kainkaryam, MD
Research Sponsored by Hartford Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are scheduled for elective primary posterior CSFS to be performed by one of the spine surgeons in the study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call
Awards & highlights

MCP Trial Summary

This trial compares MCP block to sham block to assess if MCP reduces post-op pain. Researchers will also look at opioid consumption, non-opioid analgesics, PONV, LOS, safety, patient satisfaction.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site like bruising or soreness. There's also a risk of experiencing lower blood pressure or heart rate due to Bupivacaine or Epinephrine. Dexamethasone might cause increased blood sugar levels or mood changes.

MCP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a specific spine surgery by a study surgeon.

MCP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The maximum postoperative pain score
Secondary outcome measures
Antiemetics used
Hospital and Post Anesthesia Care Unit length of stay
Non- opioid analgesics use
+5 more

MCP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MCP BlockExperimental Treatment3 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 BlockPlacebo Group1 Intervention
Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epinephrine
2014
Completed Phase 4
~3940
Bupivacain
2022
Completed Phase 4
~1610
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor
133 Previous Clinical Trials
18,894 Total Patients Enrolled
Pranjali Kainkaryam, MDPrincipal InvestigatorHartford Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals included in the current research protocol?

"This trial allows individuals aged between 40 and 80 to participate, adhering to the pre-established inclusion criteria."

Answered by AI

Is the recruitment phase of this clinical trial ongoing?

"Affirmative, according to clinicaltrials.gov this research is currently recruiting participants. This study was initially posted on December 12th 2023 and updated most recently on the following day. 38 individuals will be accepted at a solitary medical facility."

Answered by AI

What is the aggregate number of individuals participating in this research?

"Affirmative. Information accessed on clinicaltrials.gov suggests that this experiment is presently seeking participants, first posted in December of 2023 and last updated the day after. 38 patients are required to be recruited from a single medical centre."

Answered by AI

What adverse impacts could the use of MCP Block have on human health?

"Our team at Power has given the safety of MCP Block a score of 3 due to its approval as part of Phase 4 trials."

Answered by AI

Can I be included in this experiment?

"This study requires 38 participants who have undergone a cervical spine fusion and are aged between 40 and 80."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
Pranjali P Kainkaryam, MD 2023. "Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05996133.
~25 spots leftby Dec 2024
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