An interventional study of Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Standard Analgesic Cocktail in Posterior Lumbar Interbody Fusion (PLIF) and Postoperative Analgesia After Disc Surgery, sponsored by First Affiliated Hospital of Kunming Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by First Affiliated Hospital of Kunming Medical University · Not applicable, Interventional, and Treatment
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
First Affiliated Hospital of Kunming Medical University is the lead sponsor of 18 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
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
Drug: Standard Analgesic Cocktail
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.
Drug: Modified Analgesic Cocktail
Drug page: Liposomal Bupivacaine
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.
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.
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.
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.
Time frame: Preoperative baseline; 0-72 hours postoperatively
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Liposomal Bupivacaine
First Affiliated Hospital of Kunming Medical University