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Application of bupivacaine liposome for fascia iliaca compartment block in total hip arthroplasty : A randomized controlled trial

Application of bupivacaine liposome for fascia iliaca compartment block in total hip arthroplasty : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115648
Enrollment
Unknown
Registered
2025-12-29
Start date
2025-04-25
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Total hip replacement surgery

Interventions

Liposome bupivacaine group (Group A):10ml (133mg) of bupivacaine lipid solution plus 20ml of 0.9% normal saline, totaling 30ml.
Bupivacaine group (Group B): 0.25% bupivacaine, 30 ml.
Ropivacaine group (Group C):0.3% ropivacaine, 30 ml.

Sponsors

The Second Hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 95 Years

Inclusion criteria

Inclusion criteria: (1) Age >= 60 years old; (2) BMI: 18 - 28 kg/m^2; (3) American Society of Anesthesiologists (ASA) classification I - III; (4) Scheduled for anterior approach total hip arthroplasty (THA) under spinal anesthesia; (5) Estimated operation time within 120 minutes; (6) No coagulation dysfunction, no history of taking anticoagulant drugs such as aspirin in the recent period; (7) Agree to participate in this study and sign the informed consent form; (8) Able to understand the visual analogue scale (VAS) and provide feedback information.

Exclusion criteria

Exclusion criteria: (1) Difficulty in assessing pain due to cognitive impairment; (2) Allergy or intolerance to sulfonamide drugs; (3) Severe coagulation dysfunction; (4) Patients with peripheral neuropathy or those receiving chronic non-hip joint pain treatment; (5) Severe kidney or liver damage, combined with possible complications that may affect postoperative recovery; (6) Infection at the puncture site; (7) Previous hip joint surgery involving the affected joint; (8) Regular opioid or glucocorticoid treatment before fracture; (9) Alcohol or drug abuse; (10) Refusal to use analgesic pumps after surgery; (11) Left ventricular ejection fraction (LVFE) of less than 30% before surgery; (12) Other reasons deemed unsuitable for participation in the trial by the researchers.

Design outcomes

Primary

MeasureTime frame
The cumulative consumption of opioid drugs within 72 hours after the operation;;Using the Visual Analogue Scale (VAS): The pain scores at rest or during movement (passive 90° hip flexion) were observed at 6 hours after the operation.;Using the Visual Analogue Scale (VAS): The pain scores at rest or during movement (passive 90° hip flexion) were observed at 12 hours after the operation;Using the Visual Analogue Scale (VAS): The pain scores at rest or during movement (passive 90° hip flexion) were observed at 24 hours after the operation;Using the Visual Analogue Scale (VAS): The pain scores at rest or during movement (passive 90° hip flexion) were observed at 48 hours after the operation;Using the Visual Analogue Scale (VAS): The pain scores at rest or during movement (passive 90° hip flexion) were observed at 72 hours after the operation;

Secondary

MeasureTime frame
The number of PCA presses and the additional consumption of opioid drugs in the ward within 0-24 hours after the first administration;The time from the end of the surgery to the first administration of analgesic drugs after the operation;The time of the first standing;Record the occurrence of adverse reactions (nausea, vomiting, dizziness, tinnitus) during the medication process of the patients.;The time of the first swalking;The TUG test score;The length of hospital stay;The number of PCA presses and the additional consumption of opioid drugs in the ward within 24-48 hours after the first administration;The number of PCA presses within 48-72 hours after the first administration;

Countries

China

Contacts

Public ContactDongnan Hou

The Second Hospital of Dalian Medical University

dongnanhouxy@163.com+86 177 0987 2323

Outcome results

None listed

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