Back PainPhase 2/3NCT06350981
Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion
A Phase 2/3 study testing Exparel and Bupivacain in people with Back Pain and Surgery-Complications, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain, Surgery-Complications, Narcotic Use
- What is being tested?
- Exparel and Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2024to 1 Mar 2027
- Phase
- Phase 2/3
- 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
- Patients 18 years or older,
- Patients admitted to AHC for 1-3 level TLIF,
- Patients who have given written informed consent,
- BMI between 18-35 kg/m2,
Who cannot join
- Patients with known allergic reactions to standard of care analgesics,
- Female patients who are pregnant
- Patients with any previous lumbar spine instrumented surgery,
- Chronic opioid use within 30 days prior to randomization that exceeds average ≥30 oral morphine equivalents/day,
- Patients with known allergy to local anesthetics,
- Patients with known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g. myasthenia gravis).
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
Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
About this study
Official title: Analgesic Requirement for Post-Operative Pain Control in Elective 1-3 Level Transforaminal Lumbar Interbody Fusion: Comparison of Thoracolumbar Interfascial Plane Block With Exparel to Bupivacaine HCl
The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.
- Being tested
- Exparel, Bupivacain
- Medical subject headings
- Back Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine
BupivacainDrug
Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL
| Study group | Role | What they receive |
|---|---|---|
| Exparel TLIP Injection | Experimental | Subjects will receive 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine. A total of 30 mL of mixed solution is injected into the thoracolumbar interfacial plane. Receives: Drug: Exparel |
| Bupivicaine HCL TLIP Injection | Active comparator | Standard of care will consist of 0.25% Bupivacaine HCl TLIP injection. Subjects will receive 30 mL of the solution, injected into the thoracolumbar interfacial plane. Receives: Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.
Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery.
Measured: 0-72 hours post-operatively
Secondary outcomes (8)
Total Postsurgical opioid consumption
The following data points will be recorded to further claim the investigators hypothesis of treatment with EXPAREL compared to Bupivacaine hydrochloride.
- Total postsurgical opioid consumption in oral morphine equivalents (Oral morphine equivalents) from 0 to 76 hours post-surgery
Measured: 0-72 hours postoperatively
Time to discharge
collect hours of hospital stay
Measured: 0-72 hours postoperatively
Time to ambulation
collect time ambulated from surgery
Measured: 0-72 hours postoperatively
Maximum ambulated distance
Physical Therapy will document the distance subject could ambulate after surgery
Measured: 0-72 hours postoperatively
Numeric Rating Pain Scale (Physical Therapy)
Measure pain score (scale of 0-10 with 0 indicates no pain and 10 severe pain) during physical therapy (ambulation)
Measured: 0-72 hours postoperatively
Numeric Rating Pain Scale
Numerical rating scale pain intensity scores at 24hour, 36hour, 60hour, and 72hour from the end of surgery and again at the first clinic visit postoperatively (scale of 0-10 with 0 indicates no pain and 10 severe pain)
Measured: 0-72 hours with additional follow-up at 14 days (first clinic visit)
Oswestry Disability Index (ODI)
10 questions relating to function specific to low back pain given before surgery and collected at 14 day post op visit.
Measured: 0- 14 days postoperatively
Pain Catastrophizing Scale (PCS)
This scale measures thoughts and feelings that may be associated with pain. it is rated 0-5 with 0 indicating not at all, 1 indicating to a slight degree, 2 indicates a moderate degree, 3 indicates a great degree and 4 idicates all the time.
There are 13 statements that are rated, the ratings are scored to determine where each subject falls in the scale.
Measured: 0-14 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start30 Apr 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- John Small, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350981
- Sponsor's protocol ID
- FORE813
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Requirement for Post-Operative Pain Control in Elective 1-3 Level Transforaminal Lumbar Interbody Fusion: Comparison of Thoracolumbar Interfascial Plane Block With Exparel to Bupivacaine HCl
- ClinicalTrials.gov ID
- NCT06350981
- Acronym / sponsor ID
- FORE813
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Apr 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.
The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel TLIP Injection | Experimental | Drug: ExparelSubjects will receive 20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine. A total of 30 mL of mixed solution is injected into the thoracolumbar interfacial plane. |
| Bupivicaine HCL TLIP Injection | Active comparator | Drug: BupivacainStandard of care will consist of 0.25% Bupivacaine HCl TLIP injection. Subjects will receive 30 mL of the solution, injected into the thoracolumbar interfacial plane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years or older,
- Patients admitted to AHC for 1-3 level TLIF,
- Patients who have given written informed consent,
- BMI between 18-35 kg/m2,
Key exclusion criteria (6 listed)
- Patients with known allergic reactions to standard of care analgesics,
- Female patients who are pregnant
- Patients with any previous lumbar spine instrumented surgery,
- Chronic opioid use within 30 days prior to randomization that exceeds average ≥30 oral morphine equivalents/day,
- Patients with known allergy to local anesthetics,
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 |
|---|---|---|
| Exparel20 mL of EXPAREL 266mg mixed with 10 mL of 0.25% bupivacaine | Drug | Exparel TLIP Injection |
| BupivacainStandard of care will consist of 0.25% Bupivacaine HCl TLIP injection 30mL | Drug | Bupivicaine HCL TLIP Injection |
Primary outcome
Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion.
Time frame: 0-72 hours post-operatively
Data will be analyzed by randomized treatment group to determine efficacy. Superiority of treatment with EXPAREL compared with Bupivacaine hydrochloride will be determined using linear regression adjusting for Pain Catastrophizing Scale with treatment as main effect for the primary efficacy endpoint of area under the curve of the Numerical rating scale pain intensity scores from 0 to 72 hours post-surgery.
8 secondary outcomes
Total Postsurgical opioid consumption
Time frame: 0-72 hours postoperatively
Time to discharge
Time frame: 0-72 hours postoperatively
Time to ambulation
Time frame: 0-72 hours postoperatively
Maximum ambulated distance
Time frame: 0-72 hours postoperatively
Numeric Rating Pain Scale (Physical Therapy)
Time frame: 0-72 hours postoperatively
Numeric Rating Pain Scale
Time frame: 0-72 hours with additional follow-up at 14 days (first clinic visit)
Oswestry Disability Index (ODI)
Time frame: 0- 14 days postoperatively
Pain Catastrophizing Scale (PCS)
Time frame: 0-14 days postoperatively
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 9 Sep 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.
John Small, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Exparel and Bupivacain in people with Back Pain and Surgery-Complications, run by Foundation for Orthopaedic Research and Education 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 6 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare efficacy of thoracolumbar interfacial plane block with Exparel vs. standard of care (0.25% Bupivacaine HCL) is surgical subjects undergoing 1-3 level elective transforaminal lumbar interbody fusion. (time frame: 0-72 hours post-operatively). 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 9 Sep 2026.