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A double-blind randomized controlled clinical study to compare the analgesic effects of bupivacaine liposome and bupivacaine hydrochloride in the postoperative analgesia of ultrasound-guided erector spinae plane block in posterior lumbar internal fixation surgery.

A double-blind randomized controlled clinical study to compare the analgesic effects of bupivacaine liposome and bupivacaine hydrochloride in the postoperative analgesia of ultrasound-guided erector spinae plane block in posterior lumbar internal fixation surgery.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076158
Enrollment
Unknown
Registered
2023-09-26
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

lumbar degenerative disease

Interventions

bupivacaine liposome :bupivacaine liposome applied in ultrasound-guided erector spinae plane block
bupivacaine hydrochloride :bupivacaine hydrochloride applied in ultrasound-guided erector spinae plane block

Sponsors

The Seventh Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 74 adult patients with ASA grade I-III who underwent elective posterior lumbar surgery, aged over 18 years old;

Exclusion criteria

Exclusion criteria: 1. Allergies to bupivacaine and bupivacaine liposomes 2. Concomitant severe underlying diseases (ASA> Grade IV) 3.Infection at the puncture site or corresponding contraindications for anesthesia, such as oral anticoagulants,coagulation related blood system diseases, nerve defects at the nerve block site, and abnormal coagulation function PLT<50 4.Severe systemic chronic disease, uncontrolled and severe liver dysfunction (Child Pugh C grade); Severe renal dysfunction (receiving dialysis treatment before surgery) 5.Patients with severe electrolyte disorders and moderate to severe anemia (Hb<90 g/L) 6.Pregnant and lactating women 7.Patients who have participated in other clinical drug trials in the past 3 months 8.Drug Addicts 9. Patient cannot cooperate 10. Previous history of lumbar spine surgery

Design outcomes

Primary

MeasureTime frame
postoperative analgesic consumption;

Secondary

MeasureTime frame
Visual analogue scale Score;adverse event;Hospitalization days;

Countries

China

Contacts

Public ContactWei Fuxin

The Seventh Affiliated Hospital , Sun Yat-sen University, China

weifuxin@mail.sysu.edu.cn+86 135 6017 0686

Outcome results

None listed

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