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

• Sponsor: Hartford Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05996133
• Collaborator: (none)
• Enrollment: 38
• Arms: 2
• Anticipated Duration (Months): 18

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Spine Fusion	Drug: Bupivacaine HCL; Drug: Dexamethasone; Drug: Epinephrine; Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Single-center, prospective, double-blinded, randomized controlled trialSingle-center, prospective, double-blinded, randomized controlled trial
• Masking: Double (Participant, Care Provider)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: MCP Study, A Double-Blinded, Randomized Controlled Trial To Compare MCP Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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 + 0.1mL epinephrine 1:400,000.	Drug: Bupivacaine HCL; 30 mL of 0.25% bupivacaine; Other Names: Marcaine ; Drug: Dexamethasone; 0.5 mL (5 mg) preservative-free dexamethasone; Drug: Epinephrine; 0.1mL epinephrine 1:400,000.; Other Names: Adrenaline
Sham Comparator: Sham Block Bilateral sham block using 3mL of normal saline injections subcutaneously on the neck.	Drug: Normal saline; 3 mL normal saline

Outcome Measures

Primary Outcome Measures

1. The maximum postoperative pain score [one time after 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.

Secondary Outcome Measures

1. 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.]

   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.

2. Total opioid consumption [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)

3. Non- opioid analgesics use [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.

4. Postoperative nausea/vomiting scores [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.

5. Hospital and Post Anesthesia Care Unit length of stay [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.

6. The occurrence of block complications [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.

7. Participant satisfaction with the pain management service and the overall surgery experience [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'.

8. Antiemetics used [up to 72 postoperative hours]

   The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hartford Hospital

Investigators

• Principal Investigator: Pranjali Kainkaryam, MD, Hartford Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
• 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
• 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.
• 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.
• Raja A, Hoang S, Patel P, Mesfin FB. Spinal Stenosis. 2022 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/
• Tseng V, Cole C, Schmidt MH, Abramowicz AE, Xu JL. Analgesic efficacy of paraspinal interfascial plane blocks performed with the use of neurophysiology monitoring for posterior cervical laminectomy surgery: a case series. J Spine Surg. 2021 Mar;7(1):109-113. doi: 10.21037/jss-20-644.
• 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.

• Responsible Party: Pranjali P Kainkaryam, MD, Director of Regional Anesthesia & Acute Pain Management, Hartford Hospital
• ClinicalTrials.gov Identifier: NCT05996133
• Other Study ID Numbers: HHC-2023-0156
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Pranjali P Kainkaryam, MD, Director of Regional Anesthesia & Acute Pain Management, Hartford Hospital: Posterior cervical spine fusion surgery; Multifidus Cervicis Plane Block
• Additional relevant MeSH terms: Dexamethasone; Epinephrine; Bupivacaine

Study Results

No Results Posted as of Aug 16, 2023