Postoperative PainPhase 4NCT07228039
ESP Blocks for Posterior Spinal Fusion
A Phase 4 study testing ESP Block with Bupivacaine and ESP Block with Bupivacaine + Liposomal Bupivacaine in people with Postoperative Pain, run by Duke University at 1 site in United States.
Trial summary
This prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ESP Block with Bupivacaine and ESP Block with Bupivacaine + Liposomal Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2026to Jan 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Age 18-75
- ASA physical status 1-3
- Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)
Who cannot join
- Age <18 or >75
- ASA IV or V
- Non-English speaking
- BMI >40
- Opioid dependence
- Chronic pain
Show all 12Show fewer
- Anticoagulation or coagulopathy
- Injection site infection
- Hepatic or renal insufficiency
- Allergy to study drugs
- Pregnancy
- Inability to communicate with investigators
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
Duke University
Durham, North Carolina, 27710
Stephen Davies, (831) 359 -894, stephen.c.davies@duke.edu
About this study
Official title: A Double-Blind Prospective RCT Assessment of ESP Blocks for Analgesia Following Posterior Spinal Fusion
This prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Outcomes include opioid consumption over 72 hours, pain scores, length of stay, and time to ambulation.
- Conditions
- Postoperative Pain
- Being tested
- ESP Block with Bupivacaine, ESP Block with Bupivacaine + Liposomal Bupivacaine
- Keywords
- ESP Block, Spinal Fusion, Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP Block with BupivacaineDrug
Cervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine.
ESP Block with Bupivacaine + Liposomal BupivacaineDrug
Cervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| ESP + Liposomal Bupivacaine | Experimental | Group 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine. Receives: Drug: ESP Block with Bupivacaine + Liposomal Bupivacaine |
| ESP + Plain Bupivacaine | Experimental | Group 2 receives ESP block with 0.5% plain bupivacaine. Receives: Drug: ESP Block with Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain as measured by opiate consumption
Morphine MilliEquivalents
Measured: 72 hours
Secondary outcomes (5)
Postoperative Pain at rest and with movement as measured by patient reported pain scores
Numeric Rating Scale (0-10) 0 being no pain, 10 being worst pain imaginable
Measured: 4, 8, 12, 24, 48, and 72 hours
Discharge Readiness
Hospital and PACU Length of Stay
Measured: 72 hours
Postoperative Pain Severity as measured by required time for patient controlled-analgesia
Duration of patient controlled analgesia use
Measured: 72 hours
Incidents of post-operative nausea and vomiting
Post-operative Nausea and Vomiting
Measured: 72 hours
Time to first ambulation
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start17 Sep 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Davies, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228039
- Sponsor's protocol ID
- Pro00118950
- Status last verified
- Nov 2025
- First submitted
- 12 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Prospective RCT Assessment of ESP Blocks for Analgesia Following Posterior Spinal Fusion
- ClinicalTrials.gov ID
- NCT07228039
- Acronym / sponsor ID
- Pro00118950
- Conditions
- Postoperative Pain
- Keywords
- ESP Block, Spinal Fusion, Multimodal Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Nov 2025 (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 prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Outcomes include opioid consumption over 72 hours, pain scores, length of stay, and time to ambulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP + Liposomal Bupivacaine | Experimental | Drug: ESP Block with Bupivacaine + Liposomal BupivacaineGroup 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine. |
| ESP + Plain Bupivacaine | Experimental | Drug: ESP Block with BupivacaineGroup 2 receives ESP block with 0.5% plain bupivacaine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Age 18-75
- ASA physical status 1-3
- Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)
Key exclusion criteria (12 listed)
- Age <18 or >75
- ASA IV or V
- Non-English speaking
- BMI >40
- Opioid dependence
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 |
|---|---|---|
| ESP Block with BupivacaineCervical and lumbar ESP blocks performed under ultrasound guidance using plain bupivacaine. | Drug | ESP + Plain Bupivacaine |
| ESP Block with Bupivacaine + Liposomal BupivacaineCervical and lumbar ESP blocks performed under ultrasound guidance using bupivacaine admixed with liposomal bupivacaine. | Drug | ESP + Liposomal Bupivacaine |
Primary outcome
Postoperative Pain as measured by opiate consumption
Time frame: 72 hours
Morphine MilliEquivalents
5 secondary outcomes
Postoperative Pain at rest and with movement as measured by patient reported pain scores
Time frame: 4, 8, 12, 24, 48, and 72 hours
Discharge Readiness
Time frame: 72 hours
Postoperative Pain Severity as measured by required time for patient controlled-analgesia
Time frame: 72 hours
Incidents of post-operative nausea and vomiting
Time frame: 72 hours
Time to first ambulation
Time frame: 72 hours
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 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.
Stephen Davies principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ESP Block with Bupivacaine and ESP Block with Bupivacaine + Liposomal Bupivacaine in people with Postoperative Pain, run by Duke 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 4 inclusion and 12 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 26 Oct 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain as measured by opiate consumption (time frame: 72 hours). 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 2026.