RECRUITING

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

Conditions

Cervical Spine Fusion Posterior cervical spine fusion surgery Multifidus Cervicis Plane Block

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2023-12-12

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05996133

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Aseel Walker, MD

CONTACT

(860) 972-1778

aseel.walker@hhchealth.org

Principal Investigator

Pranjali Kainkaryam, MD

PRINCIPAL_INVESTIGATOR

Hartford Hospital

Study Locations (Sites)

Hartford Hospital

Hartford, Connecticut, 06102

United States

Collaborators and Investigators

Sponsor: Hartford Hospital

Pranjali Kainkaryam, MD, PRINCIPAL_INVESTIGATOR, Hartford Hospital

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 Registration Dates

Study Start Date2023-12-12

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-12-12

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

Posterior cervical spine fusion surgery
Multifidus Cervicis Plane Block

Additional Relevant MeSH Terms

Cervical Spine Fusion