Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
NCT ID: NCT05996133
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
38 participants
INTERVENTIONAL
2023-12-12
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
Study Groups
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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.
Bupivacaine Hcl 0.25% Inj
30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.
Sham Block
Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
Normal saline
3 mL normal saline
Interventions
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Bupivacaine Hcl 0.25% Inj
30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.
Normal saline
3 mL normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
80 Years
ALL
No
Sponsors
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Hartford Hospital
OTHER
Responsible Party
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Pranjali P Kainkaryam, MD
Director of Regional Anesthesia & Acute Pain Management
Principal Investigators
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Pranjali Kainkaryam, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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/
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.
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.
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.
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
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.
Other Identifiers
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HHC-2023-0156
Identifier Type: -
Identifier Source: org_study_id
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