Multifidus Cervicis Plane Block Vs. Sham Block For Posterior Cervical Spine Fusion Surgery
ConditionCervical Spine Fusion
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHartford Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine Hcl 0.25% Inj
Drug30 mL of 0.25% bupivacaine + 0.5 mL (5 mg) preservative-free dexamethasone + 0.1 mL epinephrine 1:400,000.
Normal saline
Other intervention3 mL normal saline
Treatment groups
38 Participants
are divided into 2 treatment groupsGroup A: MCP BlockExperimental treatment 1 intervention
Group B: Sham BlockSham comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 24 hours after surgerySecondary outcomes
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.
Time frame
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)
Time frame
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.
Time frame
Up to 72 hours postoperative4
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.
Time frame
Daily at 24th, 48th, and 72th postoperative hoursSponsors and contacts
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Source ClinicalTrials.gov