Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery (MCP)

December 13, 2023 updated by: Pranjali P Kainkaryam, MD, Hartford Hospital

MCP Study, A Double-Blinded, Randomized Controlled Trial To Compare Multifidus Cervicis Plane Block (MCP) Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery (CSFS)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients 40-80 years old, males and females, of any race and any ethnic group.
  2. Patients are scheduled for elective primary posterior cervical spine fusion surgery (CSFS) to be performed by one of the spine surgeons in the study.
  3. Ability to speak and read English
  4. Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria:

  1. Emergency posterior CSFS.
  2. Revision surgery or history of previous cervical spine surgery
  3. History of allergy to local anesthetics or steroids.
  4. Patients who are coagulopathic at the time of surgery
  5. Patients with contraindications to MCP blocks, including but not limited to anatomical abnormality or previous surgical intervention that limits or prevents receiving the blocks
  6. Infection at the site of the block.
  7. Weight < 40 kg to avoid local anesthetic toxicity.
  8. 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.
  9. Patients with a history of chronic inflammatory conditions such as multiple sclerosis
  10. Refusal to participate or lack of providing the study consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCP Block
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.
Drug: Dexamethasone
0.5 mL (5 mg) preservative-free dexamethasone
Drug: Bupivacain
30 mL of 0.25% bupivacaine
Other Names:
  • Marcaine
Drug: Epinephrine
0.1 mL epinephrine 1:400,000.
Other Names:
  • Adrenaline
Sham Comparator: Sham Block
Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
Drug: Normal saline
3 mL normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum postoperative pain score
Time Frame: Up to 24 hours after surgery
The maximum pain score for the past 24 postoperative hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain reported by participants using the validated tool; Brief Pain Inventory-Short Form.
Up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The maximum, average, minimum, and current pain scores
Time Frame: 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.
The maximum, average, minimum, and current pain scores for the past 24 hours, on a scale from 0-10 where 0 is no pain and 10 is severe pain, reported by participants daily and up to 72 postoperative hours and at 2 weeks after discharge using the validated tool; Brief Pain Inventory-Short Form.
0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.
Total opioid consumption
Time Frame: at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.
The total intraoperative and postoperative opioid consumption will be measured in morphine MilliEquivalent (MME) during hospitalization on the 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge via a phone call using a question asking if the patient is still using opioids (yes/no)
at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.
Non- opioid analgesics use
Time Frame: Up to 72 hours postoperative
The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively.
Up to 72 hours postoperative
Postoperative nausea/vomiting scores
Time Frame: Daily at 24th, 48th, and 72th postoperative hours
Postoperative nausea/vomiting scores will be collected using the Simplified Postoperative Nausea and Vomiting Impact Scale, a validated measure that consists of two questions, each with a possible response score of 0-3. Response score totals of 0-2 require no intervention. Response score totals of 3-4 may necessitate antiemetic medication. Response score totals of 5-6 are considered clinically important nausea requiring medication intervention, as this would constitute patients with excessive vomiting.
Daily at 24th, 48th, and 72th postoperative hours
Hospital and Post Anesthesia Care Unit length of stay
Time Frame: Up to 72 postoperative hours
Hospital and PACU length of stay will be calculated in hours from the date and time of admission and discharge from the electronic medical records.
Up to 72 postoperative hours
The occurrence of block complications
Time Frame: Up to 72 postoperative hours
The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital.
Up to 72 postoperative hours
Participant satisfaction with the pain management service and the overall surgery experience
Time Frame: at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call
Using the Customer Satisfaction Score (CSAT) tool, prior to discharge and at 2 weeks (+/- 7 days) after discharge via a phone call by the ARC. By asking participants to rate their satisfaction with pain management service and the overall surgery experience on a five-point scale: 1- very unsatisfied; 2- Unsatisfied; 3- Neutral; 4- Satisfied; and 5- Very satisfied. The metric will be looking specifically at the percentage of happy patients. The CSAT percentage score is calculated by looking at the 4 to 5 ratings. The formula is: (The total Number of 4 and 5 responses) ÷ (Number of total responses) x 100 = % of satisfied patients, a score of 80% will be considered 'good'.
at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call
Antiemetics used
Time Frame: up to 72 postoperative hours
The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours.
up to 72 postoperative hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Pranjali Kainkaryam, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 26, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Estimated)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2023-0156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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