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Study on preoperative iliac fascial space block of bupivacaine for preoperative analgesia in patients with hip fracture surgery: a single-center, prospective, single-blind, randomized controlled study

Study on preoperative iliac fascial space block of bupivacaine for preoperative analgesia in patients with hip fracture surgery: a single-center, prospective, single-blind, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105125
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Hip fracture

Interventions

Bupivacaine liposome group: Fascia Iliaca block using bupivacaine liposomes
Ropivacaine injection group:Fascia block using ropivacaine injection
Conventional intervention group:No fascial barrier

Sponsors

Central Hospital Affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) Age >= 18 years old; (2) ASA classification Grade ?–?; (3) Scheduled for spinal anesthesia; (4) Unilateral hip fracture; (5) Elective surgery planned within 72 hours of admission; (6) Voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Presence of fractures in other locations; (2) History of myocardial infarction or unstable angina within 6 months prior to randomization, or history of severe arrhythmias such as second-degree or higher atrioventricular block, or history of NYHA Class II or higher heart function; (3) Hepatic insufficiency (serum bilirubin exceeding 34 µmol/L); (4) Renal insufficiency (estimated glomerular filtration rate [eGFR] =1.5) or use of anticoagulants (excluding aspirin); (8) International Normalized Ratio [INR] >=1.7; (9) Infection, deformity, or skin damage at the puncture site for combined spinal-epidural or nerve block; (10) History of allergy to local anesthetics (liposomal bupivacaine or bupivacaine hydrochloride); (11) History of dementia or psychiatric disorders, or inability or unwillingness to cooperate in completing the relevant trial procedures; (12) Presence of contraindications to the experimental drugs.

Design outcomes

Primary

MeasureTime frame
After the patient entered the operating room, he performed intra-spinal anesthesia and placed the lateral position (T4) NRS score;

Secondary

MeasureTime frame
After the patient is admitted to the hospital and enters the operating room, the accumulated dose of analgesic drugs during this period;Three groups of patients were admitted to the hospital(T1)2 hours after nerve block(T2)After entering the room(T3)Finished(T5)Postoperatively24h(T6)Postoperatively24h(T7)NRS score and improved Bromage score in patients' resting and exercise states, and the scoring curve is drawn based on the scoring results.;Subjects' satisfaction score for analgesic treatment;Surgeon satisfaction score for analgesic treatment;

Countries

China

Contacts

Public ContactPeikun Han

Central Hospital Affiliated to Shandong First Medical University

hanpeikun@126.com+86 133 3517 9700

Outcome results

None listed

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