Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sham Block | Sham Comparator | Bilateral sham block using 3 mL of normal saline injections subcutaneously on the neck. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-24 hours; 24-48 hours; 48-72 hours and at 2 weeks (+/- 7 days) after discharge via a phone call. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aseel Walker, MD | Contact | (860) 972-1778 | aseel.walker@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Pranjali Kainkaryam, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Recruiting | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403427 | Background | 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. | |
| 33834133 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Single-center, prospective, double-blinded, randomized controlled trial
Not provided
Not provided
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.
| Normal saline | Other | 3 mL normal saline |
|
| 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) | at 6th, 12th, 24th, 48th, and 72nd postoperative hours, and at 2 weeks (+/- 7 days) after discharge. |
| 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. | Up to 72 hours postoperative |
| 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. | Daily at 24th, 48th, and 72th postoperative hours |
| 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. | Up to 72 postoperative hours |
| 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. | Up to 72 postoperative hours |
| 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) รท (Number of total responses) x 100 = % of satisfied patients, a score of 80% will be considered 'good'. | at 72nd postoperative hour and at 2 weeks (+/- 7 days) after discharge via a phone call |
| Antiemetics used | The number of doses (frequency) of intra and postoperative antiemetics will be collected up to 72 postop hours. | up to 72 postoperative hours |
| 31075361 | 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. |
| 28723018 | Background | 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/ |
| 28802607 | 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. |
| 29433034 | 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. |
| 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 |
| 36767465 | 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. |
| 29318534 | Result | 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. |
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |