Pain, PostoperativeNCT06570577
Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Surgery
A study testing Inter-semispinalis Plane Block and Opioids in people with Pain, Postoperative, run by Stony Brook University at 1 site in United States.
Trial summary
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Inter-semispinalis Plane Block and Opioids
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to Mar 2027
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.
- Capacity to provide informed consent
Who cannot join
- Fusion and decompression due to trauma
- Emergent procedures
- Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
- There is an infection near or in the area of neck where the block will be placed.
- The patient is having a complicated surgery or a revision surgery
- Female patient with a positive pregnancy test on the day of surgery (hospital standard-of-care).
Show all 9Show fewer
- Patient has Diabetes
- Patients who have had a prior adverse reaction to bupivacaine or dexamethasone
- Patients with Glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia
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
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Eman Nada, MBBCH, 516-287-9118, Eman.Nada@stonybrookmedicine.edu
Eman Nada, MBBCH
About this study
Official title: The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.
Read the detailed description
The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.
Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.
Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.
- Conditions
- Pain, Postoperative
- Being tested
- Inter-semispinalis Plane Block, Opioids
- Keywords
- cervical fusion, opioids
- Medical subject headings
- Pain, Postoperative, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inter-semispinalis Plane BlockProcedure or surgery
Also called ISP nerve block
A nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain.
OpioidsDrug
Also called Pharmacologic pain management
Routine Pain Management
| Study group | Role | What they receive |
|---|---|---|
| Routine Pain Management | Active comparator | Routine Pain Management will include standard of care pharmacological management, by using patient-controlled opioid analgesia, oral acetaminophen, intravenous Ketorolac (Toradol), and Gabapentin. As needed (PRN), Intravenous hydromorphone will be given for breakthrough pain. Receives: Drug: Opioids |
| Routine Pain Management plus an Inter-semispinalis Plane Block | Experimental | Routine Pain Management, as described above, plus and ISP Block. After general anesthesia has begun, in the operating room, and the patient is moved to the prone position, before surgery start, those patients who are randomized to the block group, will receive a bilateral ISP nerve block in the back of the neck under ultrasound guidance, by a qualified, experienced Anesthesiologist.
Under complete aseptic technique using an ultrasound guidance, 20 ml of Bupivacaine 0.25 % with 2 mg of Dexamethasone will be injected between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane.
Once the block is completed, the surgical procedure will proceed as usual. Receives: Procedure: Inter-semispinalis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower opioid use
Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group.
Measured: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Secondary outcomes (4)
Lower opioid use.
MME from anesthesia induction time until PACU arrival time.
Measured: MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.
Lower opioid use
MME for the 24 hours after PACU arrival time
Measured: 24 hours after PACU arrival time
Pain Scores
Using a Numeric Rating Scale (NRS), pain scores will be obtained at specified times and then compared between the two groups. Participants will be asked to rate their pain on a scale from 0 - 10, where zero represents 'no pain at all' and 10 represents 'the worst pain ever possible'.
Measured: 48 hours after PACU arrival time
Length of hospital stay
The length of hospital stay will be compared between the two groups.
Measured: The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start21 Feb 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, blinded, 2-arm study of 60 participants. Two groups of 30 patients will be randomized to either 1) Routine pain management or 2) Inter-semispinalis Plane (ISP) Block plus Routine Pain Management.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Nada, Stony Brook University
- Investigators
- Eman Nada, MBBCH, Principal investigator, Stony Brook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570577
- Sponsor's protocol ID
- IRB2024-00227
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Surgery
- ClinicalTrials.gov ID
- NCT06570577
- Acronym / sponsor ID
- IRB2024-00227
- Conditions
- Pain, Postoperative
- Keywords
- cervical fusion, opioids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants who have a surgical procedure called Posterior Cervical (neck) Spine Surgery will normally need pain medication to relieve post operative pain. This usually includes opioid medications. In this study, the consented participant may receive a nerve block procedure, in addition to the pain relieving medication. There is a fifty-fifty chance to receive the nerve block. The goal is to see if the nerve block group needs less opioid medication, has lower pain scores and is discharged from the hospital sooner.
Detailed description
The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane (ISP) block after posterior cervical spine surgery.
Posterior cervical fusion (PCF) is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain. Uncontrolled pain can result in a delay in recovery and discharge. Additionally, high doses of opioids carry the risk of opioid dependence, and other side effects, include nausea, vomiting, sedation, and, in rare cases, respiratory depression. For all of the above reasons, reducing the use of opioids is of utmost importance.
Nerve blocks are one alternative to opioid use. The ISP block is a procedure described in 2017; it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. It is done under ultrasound guidance and, although a limited number of studies have shown promise, more data on its safety and efficacy are needed. The addition of Dexamethasone to local anesthetics, in nerve blocks, resulted in significant prolongation of the analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, blinded, 2-arm study of 60 participants. Two groups of 30 patients will be randomized to either 1) Routine pain management or 2) Inter-semispinalis Plane (ISP) Block plus Routine Pain Management.
| Arm | Type | Receives |
|---|---|---|
| Routine Pain Management | Active comparator | Drug: OpioidsRoutine Pain Management will include standard of care pharmacological management, by using patient-controlled opioid analgesia, oral acetaminophen, intravenous Ketorolac (Toradol), and Gabapentin. As needed (PRN), Intravenous hydromorphone will be given for breakthrough pain. |
| Routine Pain Management plus an Inter-semispinalis Plane Block | Experimental | Procedure: Inter-semispinalis Plane BlockRoutine Pain Management, as described above, plus and ISP Block. After general anesthesia has begun, in the operating room, and the patient is moved to the prone position, before surgery start, those patients who are randomized to the block group, will receive a bilateral ISP nerve block in the back of the neck under ultrasound guidance, by a qualified, experienced Anesthesiologist. Under complete aseptic technique using an ultrasound guidance, 20 ml of Bupivacaine 0.25 % with 2 mg of Dexamethasone will be injected between two muscles in the back of the neck, bilaterally, to block the nerves that run in this plane. Once the block is completed, the surgical procedure will proceed as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having Posterior Cervical Spine Surgery from C2 - C7, which may extend to the upper thoracic vertebrae, inclusive to T3.
- Capacity to provide informed consent
Key exclusion criteria (9 listed)
- Fusion and decompression due to trauma
- Emergent procedures
- Patient is on a medication-assisted treatment, e.g., buprenorphine, naltrexone or methadone.
- There is an infection near or in the area of neck where the block will be placed.
- The patient is having a complicated surgery or a revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inter-semispinalis Plane BlockAlso: ISP nerve blockA nerve block targeting the dorsal rami of the cervical spinal nerves can help alleviate postoperative incisional pain. | Procedure or surgery | Routine Pain Management plus an Inter-semispinalis Plane Block |
| OpioidsAlso: Pharmacologic pain managementRoutine Pain Management | Drug | Routine Pain Management |
Primary outcome
Lower opioid use
Time frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time
Comparison of the reduction in Morphine Milligram Equivalent (MME) dose of opioids consumed between the control group versus the nerve block group.
4 secondary outcomes
Lower opioid use.
Time frame: MME use will be recorded from the patient's Anesthesia induction time until the patient's PACU arrival time. This will be the intra-operative period, which may last several hours, but not expected to exceed eight hours.
Lower opioid use
Time frame: 24 hours after PACU arrival time
Pain Scores
Time frame: 48 hours after PACU arrival time
Length of hospital stay
Time frame: The patient's EMR will record the date and time of admission, as well as, the date and time of discharge. This will be quantified by the REDCap software being used for this study, and is not expected to exceed four days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman Nada, MBBCH principal investigator
Stony Brook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inter-semispinalis Plane Block and Opioids in people with Pain, Postoperative, run by Stony Brook University 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 2 inclusion and 9 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 29 Apr 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Eman Nada, MBBCH (516-287-9118, Eman.Nada@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower opioid use (time frame: 48 hours post Post-Anaesthesia Care Unit (PACU) arrival time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.