Lumbar Degenerative DiseasePhase 4ESPBNCT06658054
Erector Spinae Plan Block (ESPB) with Dexmedetomidine and Dexamethasone in Lumbar Spine Fusion
A Phase 4 study testing Adjuvant analgesia in people with Lumbar Degenerative Disease, run by University of Southern California.
Trial summary
This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Degenerative Disease
- What is being tested?
- Adjuvant analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies
- Aged 18 years or older
- English-speaking patients
Who cannot join
- Patients with surgical indications for infection, malignancy, or trauma
- women who are pregnancy or breastfeeding
- Patients with respiratory compromise
- Patients who are smokers
- Patients with allergies to local anesthetics, and/or opioid medications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Efficacy of Erector Spinae Plane Block with Dexmedetomidine and Dexamethasone As Adjuvants in Single to Three-Level Lumbar Spine Fusion
This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). In the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. This possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery.
We try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.
Read the detailed description
Regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. Erector spinae plane blocks (ESPB) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. This study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in ESPB improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. It will also assess the impact of these adjuncts on postoperative nausea and vomiting (PONV) and anti-emetic medication requirements. The study employs a randomized, double-blind design, with participants divided into two groups: ESPB without adjuvants (Group A) and ESPB with dexmedetomidine and dexamethasone (Group B). Primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (VAS) pain scores. The results of this investigation will provide valuable insights into the efficacy of ESPB with adjuncts in postoperative pain management in lumbar spinal fusion patients.
- Conditions
- Lumbar Degenerative Disease
- Being tested
- Adjuvant analgesia, Control (Standard treatment)
- Keywords
- analgesia, ESPB, erector spinae plane block, dexmedetomidine, dexamethasone, bupivacaine, randomized, blinded, postoperative, opioid, PONV, nausea, vomitting, fusion
- Medical subject headings
- Agnosia, Postoperative Nausea and Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant analgesiaDrug
Patients will receive adjuvant dexmedetomidine (25mcg) and dexamethasone (5mg) in addition to bupivacaine.
Control (Standard treatment)Drug
Patient will receive standard ESPB with bupivacaine and normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group A (control) | Active comparator | Patients will receive an erector spinae plane block (ESPB) with 20 cc solution per single-shot injection comprised of 0.25% bupivacaine and 0.9% normal saline under ultrasound guidance to be administered bilaterally (40 cc total). Receives: Drug: Control (Standard treatment) |
| Group B (Intervention) | Active comparator | Patients will receive ESPB with 20cc solution per single-shot injection comprised of 0.25% bupivacaine, 25mcg dexmedetomidine, and 5mg dexamethasone under ultrasound guidance to be administered bilaterally (40 cc total). This is in addition to the bupivacaine. Receives: Drug: Adjuvant analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
measured in morphine milligram equivalents (MME)
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul S. Lee, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658054
- Sponsor's protocol ID
- HS-23-00440
- Acronym
- ESPB
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Aggregated data will be shared during publication.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Erector Spinae Plane Block with Dexmedetomidine and Dexamethasone As Adjuvants in Single to Three-Level Lumbar Spine Fusion
- ClinicalTrials.gov ID
- NCT06658054
- Acronym / sponsor ID
- ESPB / HS-23-00440
- Conditions
- Lumbar Degenerative Disease
- Keywords
- analgesia, ESPB, erector spinae plane block, dexmedetomidine, dexamethasone, bupivacaine, randomized, blinded
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Nov 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Oct 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.
This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). In the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. This possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery.
We try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.
Detailed description
Regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. Erector spinae plane blocks (ESPB) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. This study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in ESPB improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. It will also assess the impact of these adjuncts on postoperative nausea and vomiting (PONV) and anti-emetic medication requirements. The study employs a randomized, double-blind design, with participants divided into two groups: ESPB without adjuvants (Group A) and ESPB with dexmedetomidine and dexamethasone (Group B). Primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (VAS) pain scores. The results of this investigation will provide valuable insights into the efficacy of ESPB with adjuncts in postoperative pain management in lumbar spinal fusion patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (control) | Active comparator | Drug: Control (Standard treatment)Patients will receive an erector spinae plane block (ESPB) with 20 cc solution per single-shot injection comprised of 0.25% bupivacaine and 0.9% normal saline under ultrasound guidance to be administered bilaterally (40 cc total). |
| Group B (Intervention) | Active comparator | Drug: Adjuvant analgesiaPatients will receive ESPB with 20cc solution per single-shot injection comprised of 0.25% bupivacaine, 25mcg dexmedetomidine, and 5mg dexamethasone under ultrasound guidance to be administered bilaterally (40 cc total). This is in addition to the bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies
- Aged 18 years or older
- English-speaking patients
Key exclusion criteria (5 listed)
- Patients with surgical indications for infection, malignancy, or trauma
- women who are pregnancy or breastfeeding
- Patients with respiratory compromise
- Patients who are smokers
- Patients with allergies to local anesthetics, and/or opioid medications
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 |
|---|---|---|
| Adjuvant analgesiaPatients will receive adjuvant dexmedetomidine (25mcg) and dexamethasone (5mg) in addition to bupivacaine. | Drug | Group B (Intervention) |
| Control (Standard treatment)Patient will receive standard ESPB with bupivacaine and normal saline | Drug | Group A (control) |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours postoperatively
measured in morphine milligram equivalents (MME)
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 26 Oct 2024.
- Individual participant dataSharing planned: Undecided. Aggregated data will be shared during publication.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjuvant analgesia in people with Lumbar Degenerative Disease, run by University of Southern California.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Paul S Lee ((323) 442-7400, pauls.lee@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 24 hours postoperatively). 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 26 Oct 2024.