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Effects of a Modified Cocktail on analgesia and early functional recovery in Short-Segment Posterior Lumbar Interbody Fusion Surgery: a prospective, double-blind randomized controlled trial

Effect of oxeridine prophylactic analgesia combined with local "cocktail" infiltration on pain and accelerated recovery after short-level lumbar PLIF surgery: a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103585
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc degeneration diseases of the the lumbar spine

Interventions

Group A:(Cocktail group) Group: Ropivacaine 200mg+Adrenaline 0.2mg+Dexamethasone 10mg+NS47ml
Group B:Preventive analgesia group: intravenous administration of 2mg oxaliplatin for preventive analgesia during anesthesia induction
Group C:Cocktail + preventive analgesia combination group: 2mg oxelidine was given intravenously for preventive analgesia + ropivacaine 200mg+ epinephrine 0.2

Sponsors

The First Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 Age: 40 ~ 70 years old; 2 Confirmed lumbar disc herniation, lumbar spondylolisthesis or lumbar spinal stenosis; 3 1-2 stage PLIF surgery was performed; ?Preoperative American Society of Anesthesiologists (ASA) classification (anesthesia risk assessment) is grade I to III.

Exclusion criteria

Exclusion criteria: 1 Patients with tuberculosis, tumor, infection, fracture, metabolic bone disease and other spinal diseases; 2 Previous history of thoracolumbar posterior surgery or trauma; 3 Patients with drug allergies used in this study; 4 Patients with heart, lung and other important organ failure or serious coagulation dysfunction; 5 Abnormal liver and kidney function (ALT, AST> 1.5 times normal value, blood BUN>-8.3 mmoll, blood Scr>115 umol/L); 6 Patients with diabetes and poorly controlled blood sugar levels who are judged by researchers to be at risk of infection; 7 There is an active infection in the body (systemic or local infection lesions); 8 Women during family planning, lactation and pregnancy throughout the clinical study period; 9 Participants who have participated in other clinical trials within 3 months or who are not suitable to participate in this clinical trial for other reasons; 10 Opioid addicts; xi. Language impairment and inability to complete the Visual analogue scale (VAS) of pain.

Design outcomes

Primary

MeasureTime frame
Time to first postoperative remedial analgesia;Total opioid use before and after surgery;Postoperative dosage of remedial morphine hydrochloride;

Secondary

MeasureTime frame
Visual analogue scale pain score;Postoperative recovery quality;Inflammatory index;Accelerated rehabilitation index;Complication rate;

Countries

China

Contacts

Public ContactChen Changjun

The First Affiliated Hospital of Shandong First Medical University

1012374168@qq.com+86 130 7531 9306

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026