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Cervical Spine FusionPhase 4MCPNCT05996133

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

A Phase 4 study testing Bupivacaine Hcl 0.25% Inj and Normal saline in people with Cervical Spine Fusion, run by Hartford Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Cervical Spine Fusion
What is being tested?
Bupivacaine Hcl 0.25% Inj and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
38 participants
Where
1 siteUnited States
Study dates
12 Dec 2023to 30 Jun 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Hartford Hospital

    Hartford, Connecticut, 06102

    Pranjali Kainkaryam, MD, 860-972-2117, Pranjali.Kainkaryam@HHCHealth.org

    Aseel Walker, MD, 860-972-1778, aseel.walker@hhchealth.org

    Recruiting

Other trials in United States

About this study

Official title: Comparing Multifidus Cervicis Plane Block Vs. Sham Block, In Reducing Postoperative Pain And Opioid Consumption In Patients Undergoing Elective Primary Posterior Cervical Spine Fusion Surgery

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.
Being tested
Bupivacaine Hcl 0.25% Inj, Normal saline
Keywords
Posterior cervical spine fusion surgery, Multifidus Cervicis Plane Block
Medical subject headings
Klippel-Feil Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bupivacaine Hcl 0.25% InjDrug

    Also called Dexamethasone, Epinephrine

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

  • Normal salineOther

    3 mL normal saline

Study groups in NCT05996133
Study groupRoleWhat they receive
MCP BlockExperimentalBilateral 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.
Receives: Drug: Bupivacaine Hcl 0.25% Inj
Sham BlockSham comparatorBilateral sham block using 3 mL of normal saline injections subcutaneously on the neck.
Receives: Other: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 hours after surgery

Secondary outcomes (8)
  1. The maximum, average, minimum, and current pain scores

    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.

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

  2. Total opioid consumption

    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)

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

  3. Non- opioid analgesics use

    The number of non-opioid analgesics used (frequency), including NSAIDs, muscle relaxants, and gabapentin at any time throughout hospitalization up to 72 hours postoperatively.

    Measured: Up to 72 hours postoperative

  4. Postoperative nausea/vomiting scores

    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.

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

  5. Hospital and Post Anesthesia Care Unit length of stay

    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.

    Measured: Up to 72 postoperative hours

  6. The occurrence of block complications

    The occurrence of block complications will be collected during hospitalization will be assessed daily for up to the discharge from the hospital.

    Measured: Up to 72 postoperative hours

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

    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'.

    Measured: at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call

  8. Antiemetics used

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

    Measured: up to 72 postoperative hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start12 Dec 2023
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center, prospective, double-blinded, randomized controlled trial
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996133
Sponsor's protocol ID
HHC-2023-0156
Acronym
MCP
Status last verified
Aug 2025
First submitted
26 Jul 2023
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28403427
  • 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.

    PubMed 33834133
  • 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.

    PubMed 31075361
  • Raja A, Patel P, Mesfin FB. Spinal Stenosis(Archived). 2023 Jun 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441989/

    PubMed 28723018
  • 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.

    PubMed 28802607
  • 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.

    PubMed 29433034
  • 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.

    PubMed 36767465
  • 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.

    PubMed 29318534

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine Hcl 0.25% Inj and Normal saline in people with Cervical Spine Fusion, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aseel Walker, MD ((860) 972-1778, aseel.walker@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum postoperative pain score (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05996133, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025; AzTrials last refreshed its copy on 5 Nov 2026.

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