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

NCT05996133 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HHC-2023-0156
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Spine Fusion

Keywords

Posterior cervical spine fusion surgery; Multifidus Cervicis Plane Block

Outcome Measures

Primary Outcomes (1)

• The maximum postoperative pain score

  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 Outcomes (8)

• The maximum, average, minimum, and current pain scores

  0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call.

• Total opioid consumption

  at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge.

• Non- opioid analgesics use

  Up to 72 hours postoperative

• Postoperative nausea/vomiting scores

  Daily at 24th, 48th, and 72th postoperative hours

• Hospital and Post Anesthesia Care Unit length of stay

  Up to 72 postoperative hours

Study Arms (2)

MCP Block

EXPERIMENTAL

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: Bupivacaine Hcl 0.25% Inj

Sham Block

SHAM COMPARATOR

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

Other: Normal saline

Interventions

Bupivacaine Hcl 0.25% Inj DRUG

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

Also known as: Dexamethasone, Epinephrine

MCP Block

Normal saline OTHER

3 mL normal saline

Sham Block

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Related Publications (9)

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

  PMID: 28403427 BACKGROUND

• Minor PD, Macadam AJ, Stone DM, Almond JW. Genetic basis of attenuation of the Sabin oral poliovirus vaccines. Biologicals. 1993 Dec;21(4):357-63. doi: 10.1006/biol.1993.1096. No abstract available.

  PMID: 8024751 BACKGROUND

• Youssef JA, Heiner AD, Montgomery JR, Tender GC, Lorio MP, Morreale JM, Phillips FM. Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis. Spine J. 2019 Oct;19(10):1714-1729. doi: 10.1016/j.spinee.2019.04.019. Epub 2019 May 7.

  PMID: 31075361 BACKGROUND

• Raja A, Patel P, Mesfin FB. Spinal Stenosis(Archived). 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/

  PMID: 28723018 BACKGROUND

• Ohgoshi Y, Kurahashi K. Cervical interfascial plane (CIP) block and multifidus cervicis plane (MCP) block: Similarities and tips. J Clin Anesth. 2017 Sep;41:55. doi: 10.1016/j.jclinane.2017.06.014. Epub 2017 Jun 27. No abstract available.

  PMID: 28802607 BACKGROUND

• Ohgoshi Y, Kubo EN. Inter-semispinal plane block for cervical spine surgery. J Clin Anesth. 2018 May;46:94-95. doi: 10.1016/j.jclinane.2018.02.007. Epub 2018 Feb 9. No abstract available.

  PMID: 29433034 BACKGROUND

• Ahiskalioglu A, Yayik AM, Doymus O, Selvitopi K, Ahiskalioglu EO, Calikoglu C, Alici HA, Karaca O. Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for postoperative analgesia after spinal surgery: a randomized-controlled trial. Can J Anaesth. 2018 May;65(5):603-604. doi: 10.1007/s12630-018-1051-0. Epub 2018 Jan 9. No abstract available.

  PMID: 29318534 BACKGROUND

• Mohamed, Z.E., Zarad, C.A., Flifel, M.E. et al. The efficacy of ultrasound-guided multifidus cervicis plane block versus greater occipital nerve block for cervicogenic headache. Egypt J Neurol Psychiatry Neurosurg 57, 11 (2021). https://doi.org/10.1186/s41983-020-00262-4

  BACKGROUND

• Adamczyk K, Koszela K, Zaczynski A, Niedzwiecki M, Brzozowska-Mankowska S, Gasik R. Ultrasound-Guided Blocks for Spine Surgery: Part 1-Cervix. Int J Environ Res Public Health. 2023 Jan 23;20(3):2098. doi: 10.3390/ijerph20032098.

  PMID: 36767465 BACKGROUND

MeSH Terms

Conditions

Klippel-Feil Syndrome

Interventions

Bupivacaine; Dexamethasone; Epinephrine; Saline Solution

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pranjali Kainkaryam, MD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aseel Walker, MD

CONTACT

(860) 972-1778; aseel.walker@hhchealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: This is a double-blinded study, patients, research coordinators who collect data, spine surgeons, and other health care providers will all be blinded to the study group assignments to minimize bias and maximize the validity of study results. The block-performing anesthesiologists/investigators, the block nurse, and the senior scientist will not be blinded to the study group assignments. Patients will not be unblinded after they complete the study or during the study unless a participant experiences a serious adverse event that is unexpected and related to the study intervention (MCP or sham block) and the course of treatment needs to be adjusted. Unblinding in this situation will be the decision of the principal investigator (PI). The PI will contact the Senior Scientist to get the patient's group assignment, and the PI will then unblind the patient (i.e., tell the patient about the assigned group), and take any additional necessary course of treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Regional Anesthesia & Acute Pain Management

Model Details: Single-center, prospective, double-blinded, randomized controlled trial

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 16, 2023
• Study Start: December 12, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)