Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery

June 7, 2026 updated by: Dong-Xin Wang, Peking University First Hospital

Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Fracture Surgery: a Randomized Trial

Older patients with hip fractures often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (e.g., plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia within 72 hours after surgery in older patients undergoing hip fracture surgery, decrease opioid consumption, and improve postoperative recovery quality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hip fracture is a global health concern. Data from 204 countries over the past 30 years show an increasing incidence of hip fractures in people over 55 years old. With population aging, China is projected to have 1.3 million new geriatric hip fracture cases annually by 2050, imposing a heavy burden on individuals, families, and healthcare systems. Timely surgery remains the preferred treatment.

Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.

Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.

Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine provides superior perioperative analgesia compared with plain bupivacaine in older (≥55 years) patients undergoing hip fracture surgery.

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged ≥ 55 years.
  • Diagnosed as hip fracture and scheduled to undergo hip replacement surgery.
  • Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).

Exclusion Criteria:

  • Inability to communicate due to visual, auditory, language, or other reasons before surgery.
  • Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
  • Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
  • Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
  • Known allergy to local anesthetics.
  • Any other condition that the investigator or attending physician deems unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block is performed in the preoperative holding area.
Drug: Liposomal bupivacaine (LB)
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL. The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip placement between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
Active Comparator: Plain bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block. The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg). The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle. The block is performed in the preoperative holding area.
Drug: Plain bupivacaine
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg). The injection will be performed after negative aspiration and under real-time ultrasound guidance to ensure proper spread between the fascia iliaca and the iliacus muscle. The block is performed in the preoperative holding area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The area under curve of pain intensity within 72 hours after surgery
Time Frame: Up to 72 hours after the surgery
Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey. The area under curve of pain intensity will be calculated using the trapezoidal rule.
Up to 72 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption within 72 hours after surgery
Time Frame: Up to 72 hours after the surgery
Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
Up to 72 hours after the surgery
Incidence of cardiovascular events within 7 days after surgery
Time Frame: Up to 7 days after surgery
Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
Up to 7 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay after surgery
Time Frame: Up to 30 days after surgery
Length of hospital stay after surgery
Up to 30 days after surgery
Incidence of moderate-to-severe pain within 72 hours after surgery
Time Frame: Up to 72 hours after surgery
Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint.
Up to 72 hours after surgery
The proportion of patients receiving rescue analgesics within 72 hours after surgery.
Time Frame: Up to 72h after surgery
Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.
Up to 72h after surgery
Cumulative score of subjective sleep quality during the first three nights after surgery
Time Frame: Up to three nights after surgery
Subjective sleep quaality will be assessed with the numeric rating scale (NRS; an 11-point where 0=the best sleep and 10=the worst sleep).
Up to three nights after surgery
Quality of recovery at 24 hours after surgery
Time Frame: At 24 hours after surgery
Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluat the quality of early postoperative recovery after surgery and anesthesia. Scores range from 0 to 150, with higher scores indicating better quality of recovery).
At 24 hours after surgery
Incidence of acute kidney injuy within 7 days after surgery
Time Frame: Up to 7 days after surgery
Acute kidney injury (AKI) will be diagnosed according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) creatinine criteria. guideline . AKI is diagnosed if any one of the following criteria is met: (1) An increase in serum creatinine (SCr) by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; (2) An increase in serum creatinine to ≥ 1.5 times the baseline value, which is confirmed or presumed to have occurred within the past 7 days.
Up to 7 days after surgery
Incidence of complications within 30 days after surgery
Time Frame: Up to 30 days after surgery
Postoperative complications are generally defined as new-onset conditions that are deemed harmful and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 7, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 12, 2026

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026R0311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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