Posterior Lumbar Interbody Fusion (PLIF)NCT07919275
Comparing Long-Acting Local Pain Relief Methods in PLIF Surgery
A study testing Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Standard Analgesic Cocktail and Modified Analgesic Cocktail in people with Posterior Lumbar Interbody Fusion (PLIF) and Postoperative Analgesia After Disc Surgery, run by First Affiliated Hospital of Kunming Medical University.
Trial summary
This study is being done to compare three ways of using long-acting local pain medicine around the surgical wound during open lumbar fusion surgery. The goal is to learn which approach gives better pain relief after surgery, reduces the need for additional pain medicine such as tramadol, and causes fewer side effects… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Posterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery
- What is being tested?
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Standard Analgesic Cocktail and Modified Analgesic Cocktail
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Male or female participants aged ≥18 years and <75 years.
- Diagnosis and planned surgery: Participants with degenerative lumbar disease who are scheduled to undergo open posterior lumbar fusion surgery involving ≤3 levels.
- Clinical symptoms/signs: Participants have symptoms and signs of spinal cord or nerve root compression, such as low back pain, lower-limb numbness or weakness, gait instability, or band-like sensation, with or without bowel/bladder dysfunction due to spinal cord compression; conservative treatment has been ineffective or symptoms are progressively worsening.
- Clinical data: Participants have complete clinical data available.
- Informed consent: Participants, or their legally authorized representatives, are able to understand and sign the informed consent form.
Who cannot join
- Severe comorbidities: Severe cardiovascular or respiratory disease, or renal or hepatic insufficiency.
- Allergy: Known allergy to liposomal bupivacaine or ropivacaine.
- Prior surgery: History of previous lumbar spine surgery.
- Other spinal/clinical conditions: Tumor, infection, fracture, or other thoracolumbar spinal conditions that may affect the participant's clinical symptoms.
- Cognitive/psychiatric inability to consent: Coexisting psychiatric disease or cognitive impairment in the participant or legally authorized representative that prevents adequate informed consent.
- Unfit for surgery: Poor general condition, inability to tolerate surgery, or preoperative assessment indicating that surgery is not appropriate.
- Follow-up feasibility: Participants who are unable or unwilling to complete the required follow-up, or who are expected to be lost to follow-up.
About this study
Official title: Efficacy and Safety of Different Long-Acting Local Analgesic Regimens in Posterior Lumbar Interbody Fusion Surgery
This study is being done to compare three ways of using long-acting local pain medicine around the surgical wound during open lumbar fusion surgery. The goal is to learn which approach gives better pain relief after surgery, reduces the need for additional pain medicine such as tramadol, and causes fewer side effects such as nausea, vomiting, constipation, or wound problems. Participants will be adults aged 18 to under 75 years who are scheduled for open posterior lumbar fusion for degenerative lumbar disease and who agree to take part. They will be assigned to one of three local pain-relief regimens: liposomal bupivacaine, a standard local anesthetic cocktail, or a modified cocktail that adds magnesium sulfate. Pain scores, rescue pain medicine, side effects, quality-of-life scores, and recovery information such as length of hospital stay will be recorded during the hospital stay and up to 72 hours after surgery. This study compares marketed local anesthetics and commonly used additives in routine surgical care; it is not a first-in-human or new-drug study. The results may help doctors choose a safer and more effective pain-control plan after lumbar fusion
- Being tested
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Standard Analgesic Cocktail, Modified Analgesic Cocktail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine (EXPAREL®)/BupivacaineDrug
Single intraoperative local wound infiltration of liposomal bupivacaine 20 mL/266 mg diluted with 40 mL normal saline before wound closure. The protocol states a total volume of 120 mL; this volume discrepancy should be clarified before submission.
Standard Analgesic CocktailDrug
Local wound infiltration with ropivacaine 50 mg, dexamethasone 5 mg, epinephrine 0.2 mg, and normal saline 43.8 mL, prepared as the standard "cocktail" and administered before wound closure.
Modified Analgesic CocktailDrug
Local wound infiltration with ropivacaine 50 mg, dexamethasone 5 mg, epinephrine 0.2 mg, magnesium sulfate 125 mg, and normal saline 43.3 mL, prepared as the modified "cocktail" and administered before wound closure.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Participants receive a single intraoperative wound infiltration of liposomal bupivacaine 20 mL/266 mg diluted with 40 mL normal saline before wound closure. The solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision, with 3-5 mL infiltrated into the paraspinal muscles every 1.0-1.5 cm around the incision. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6. Receives: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine |
| Standard Cocktail Group | Active comparator | Participants receive the standard local analgesic cocktail: ropivacaine 50 mg (5 mL of 1.0% ropivacaine), dexamethasone 5 mg (1 mL), epinephrine 0.2 mg (0.2 mL), and normal saline 43.8 mL. Before wound closure, the solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision. Total injection volume (mL) = incision length × (BMI/21) × 4. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6 Receives: Drug: Standard Analgesic Cocktail |
| Modified Cocktail Group | Experimental | Participants receive the modified local analgesic cocktail: ropivacaine 50 mg (5 mL of 1.0% ropivacaine), dexamethasone 5 mg (1 mL), epinephrine 0.2 mg (0.2 mL), magnesium sulfate 125 mg (0.5 mL of 2.5 g/10 mL), and normal saline 43.3 mL. Before wound closure, the solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision. Total injection volume (mL) = incision length × (BMI/21) × 4. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6. Receives: Drug: Modified Analgesic Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed by VAS Within 72 Hours After Surgery
Pain intensity will be measured using the Visual Analogue Scale (VAS) at preoperative baseline and at 0, 6, 12, 24, 36, 48, 60, and 72 hours after surgery, and every 12 hours thereafter until discharge. The primary analysis will compare postoperative VAS scores among the liposomal bupivacaine, standard cocktail, and modified cocktail groups during the first 72 hours after surgery.
Measured: Preoperative baseline; 0-72 hours postoperatively
Total Rescue Tramadol Consumption Within 72 Hours After Surgery
Measured: 0-72 hours postoperatively
Incidence of Adverse Events Within 72 Hours After Surgery
Measured: 0-72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Lumbar Interbody Fusion (PLIF)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bing Wang, First Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919275
- Sponsor's protocol ID
- 2025-L-162
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Long-Acting Local Analgesic Regimens in Posterior Lumbar Interbody Fusion Surgery
- ClinicalTrials.gov ID
- NCT07919275
- Acronym / sponsor ID
- 2025-L-162
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Nov 2026 (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 is being done to compare three ways of using long-acting local pain medicine around the surgical wound during open lumbar fusion surgery. The goal is to learn which approach gives better pain relief after surgery, reduces the need for additional pain medicine such as tramadol, and causes fewer side effects such as nausea, vomiting, constipation, or wound problems. Participants will be adults aged 18 to under 75 years who are scheduled for open posterior lumbar fusion for degenerative lumbar disease and who agree to take part. They will be assigned to one of three local pain-relief regimens: liposomal bupivacaine, a standard local anesthetic cocktail, or a modified cocktail that adds magnesium sulfate. Pain scores, rescue pain medicine, side effects, quality-of-life scores, and recovery information such as length of hospital stay will be recorded during the hospital stay and up to 72 hours after surgery. This study compares marketed local anesthetics and commonly used additives in routine surgical care; it is not a first-in-human or new-drug study. The results may help doctors choose a safer and more effective pain-control plan after lumbar fusion
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Group | Experimental | Drug: Liposomal Bupivacaine (EXPAREL®)/BupivacaineParticipants receive a single intraoperative wound infiltration of liposomal bupivacaine 20 mL/266 mg diluted with 40 mL normal saline before wound closure. The solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision, with 3-5 mL infiltrated into the paraspinal muscles every 1.0-1.5 cm around the incision. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6. |
| Standard Cocktail Group | Active comparator | Drug: Standard Analgesic CocktailParticipants receive the standard local analgesic cocktail: ropivacaine 50 mg (5 mL of 1.0% ropivacaine), dexamethasone 5 mg (1 mL), epinephrine 0.2 mg (0.2 mL), and normal saline 43.8 mL. Before wound closure, the solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision. Total injection volume (mL) = incision length × (BMI/21) × 4. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6 |
| Modified Cocktail Group | Experimental | Drug: Modified Analgesic CocktailParticipants receive the modified local analgesic cocktail: ropivacaine 50 mg (5 mL of 1.0% ropivacaine), dexamethasone 5 mg (1 mL), epinephrine 0.2 mg (0.2 mL), magnesium sulfate 125 mg (0.5 mL of 2.5 g/10 mL), and normal saline 43.3 mL. Before wound closure, the solution is injected bilaterally at 0.8-cm intervals into the muscles and fascia around the incision. Total injection volume (mL) = incision length × (BMI/21) × 4. Rescue analgesia: tramadol 100 mg intramuscularly when VAS ≥6. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Male or female participants aged ≥18 years and <75 years.
- Diagnosis and planned surgery: Participants with degenerative lumbar disease who are scheduled to undergo open posterior lumbar fusion surgery involving ≤3 levels.
- Clinical symptoms/signs: Participants have symptoms and signs of spinal cord or nerve root compression, such as low back pain, lower-limb numbness or weakness, gait instability, or band-like sensation, with or without bowel/bladder dysfunction due to spinal cord compression; conservative treatment has been ineffective or symptoms are progressively worsening.
- Clinical data: Participants have complete clinical data available.
- Informed consent: Participants, or their legally authorized representatives, are able to understand and sign the informed consent form.
Key exclusion criteria (7 listed)
- Severe comorbidities: Severe cardiovascular or respiratory disease, or renal or hepatic insufficiency.
- Allergy: Known allergy to liposomal bupivacaine or ropivacaine.
- Prior surgery: History of previous lumbar spine surgery.
- Other spinal/clinical conditions: Tumor, infection, fracture, or other thoracolumbar spinal conditions that may affect the participant's clinical symptoms.
- Cognitive/psychiatric inability to consent: Coexisting psychiatric disease or cognitive impairment in the participant or legally authorized representative that prevents adequate informed consent.
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 |
|---|---|---|
| Liposomal Bupivacaine (EXPAREL®)/BupivacaineSingle intraoperative local wound infiltration of liposomal bupivacaine 20 mL/266 mg diluted with 40 mL normal saline before wound closure. The protocol states a total volume of 120 mL; this volume discrepancy should be clarified before submission. | Drug | Liposomal Bupivacaine Group |
| Standard Analgesic CocktailLocal wound infiltration with ropivacaine 50 mg, dexamethasone 5 mg, epinephrine 0.2 mg, and normal saline 43.8 mL, prepared as the standard "cocktail" and administered before wound closure. | Drug | Standard Cocktail Group |
| Modified Analgesic CocktailLocal wound infiltration with ropivacaine 50 mg, dexamethasone 5 mg, epinephrine 0.2 mg, magnesium sulfate 125 mg, and normal saline 43.3 mL, prepared as the modified "cocktail" and administered before wound closure. | Drug | Modified Cocktail Group |
Primary outcome
Postoperative Pain Intensity Assessed by VAS Within 72 Hours After Surgery
Time frame: Preoperative baseline; 0-72 hours postoperatively
Pain intensity will be measured using the Visual Analogue Scale (VAS) at preoperative baseline and at 0, 6, 12, 24, 36, 48, 60, and 72 hours after surgery, and every 12 hours thereafter until discharge. The primary analysis will compare postoperative VAS scores among the liposomal bupivacaine, standard cocktail, and modified cocktail groups during the first 72 hours after surgery.
Total Rescue Tramadol Consumption Within 72 Hours After Surgery
Time frame: 0-72 hours postoperatively
Incidence of Adverse Events Within 72 Hours After Surgery
Time frame: 0-72 hours 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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Standard Analgesic Cocktail and Modified Analgesic Cocktail in people with Posterior Lumbar Interbody Fusion (PLIF) and Postoperative Analgesia After Disc Surgery, run by First Affiliated Hospital of Kunming Medical University.
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 5 inclusion and 7 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 5 Nov 2026. 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.
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?
Postoperative Pain Intensity Assessed by VAS Within 72 Hours After Surgery (time frame: Preoperative baseline; 0-72 hours postoperatively). The study lists 3 primary outcomes in all. 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 5 Nov 2026.