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

NCT07643792 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2026R0311
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adults; Hip Fracture Surgery; Fascia Iliaca Block; Liposomal Bupivacaine; Postoperative Pain

Keywords

Older Adults; Hip fracture surgery; Fascia Iliaca Block; Liposomal Bupivacaine; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• The area under curve of pain intensity within 72 hours after 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 Outcomes (2)

• Cumulative opioid consumption within 72 hours after surgery

  Up to 72 hours after the surgery

• Incidence of cardiovascular events within 7 days after surgery

  Up to 7 days after surgery

Other Outcomes (7)

• Incidence of moderate-to-severe pain within 72 hours after surgery

  Up to 72 hours after surgery

• The proportion of patients receiving rescue analgesics within 72 hours after surgery.

  Up to 72h after surgery

• Cumulative score of subjective sleep quality during the first three nights after surgery

  Up to three nights after surgery

Study Arms (2)

Liposomal bupivacaine group

EXPERIMENTAL

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)

Plain bupivacaine group

ACTIVE COMPARATOR

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

Interventions

Liposomal bupivacaine (LB) DRUG

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.

Liposomal bupivacaine group

Plain bupivacaine DRUG

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.

Plain bupivacaine group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

010-83572784; wangdongxin@hotmail.com

Zhen Zhang, MD

CONTACT

+86 13681035526; zhangzhen1st@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)