FICB for Hip Fracture Pain in Elderly

NCT07762846 | Not Yet Recruiting DMC

• 2 other identifiers: LY2026-057-BIIT-2025-0528
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture is a common injury in elderly patients, often requiring surgical treatment. However, these patients frequently experience severe postoperative pain, which can delay mobility and recovery, and increase the risk of complications such as delirium, pneumonia, and prolonged hospital stay. The fascia iliaca compartment block (FICB) is a regional anesthesia technique that has been shown to provide effective pain relief for hip fracture patients. This study aims to investigate whether early administration of FICB, performed upon hospital admission before surgery, can improve postoperative rehabilitation outcomes in elderly patients with hip fracture. This is a prospective, randomized, controlled study. A total of 144 elderly patients with hip fracture will be randomly assigned to either the FICB group or the control group. The FICB group will receive ultrasound-guided FICB after being admitted to the orthopaedic ward, while the control group will receive standard analgesic care once inside the operating room. The primary outcome measure is Quality of Recovery-15 score (QoR-15 score) 24 hours post-surgery. Secondary outcomes include: QoR-15 score at 48 hours postoperatively, NRS scores and sleep duration and quality scores at preoperative and various postoperative time points, total perioperative consumption of opioids and other analgesic drugs, extubation time and emergence agitation during anesthesia recovery period, incidence of delirium from postoperative period to before discharge, length of hospital stay, and overall satisfaction score with pain management. The hypothesis of this study is that early FICB intervention, compared to standard care, will lead to better pain control, earlier mobilization, shorter hospital stay, and improved overall postoperative recovery in elderly patients with hip fracture.

Conditions

Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures); Postoperative Pain; QoR-15; Fascia Iliaca Block; Recovery of Function (G11.427.698.620); Elderly

Outcome Measures

Primary Outcomes (1)

• QoR-15 scores at 24 hours postoperatively

  The QoR-15 score was used to evaluate the effect of early intervention with liposomal bupivacaine for fascia iliaca compartment block on improving the 24-hour postoperative quality of recovery in patients undergoing hip fracture surgery.

  24 hours post-surgery

Secondary Outcomes (11)

• QoR-15 score at 48 hours postoperatively

  48 hours post-surgery

• NRS score from admission to 72 hours post-surgery

  From admission to 72 hours post-surgery

• Total Opioid Consumption (in Morphine Milligram Equivalents)

  Daily from admission up to hospital discharge, assessed up to 30 days

• Total Non-Opioid Analgesic Consumption

  Daily from admission up to hospital discharge, assessed up to 30 days

• Sleep Duration

  Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery

Study Arms (2)

Early Intervention Group

EXPERIMENTAL

Patients diagnosed with hip fracture requiring surgical treatment during the study period will be screened for eligibility after providing informed consent. Eligible patients will be randomized to this group. Patients in this group will receive ultrasound-guided fascia iliaca compartment block (FICB) upon admission to the orthopedic ward, prior to surgery. On the day of surgery, general anesthesia (combined intravenous and inhalation) will be administered. Postoperatively, patient-controlled intravenous analgesia (PCIA) with sufentanil 1.5-2 μg/kg (total volume 100 mL, continuous dose 2 mL/h, bolus dose 2 mL, lockout interval 15 min) will be provided.

Procedure: Ultrasound-Guided Fascia Iliaca Compartment Block

Non-Early Intervention Group

ACTIVE COMPARATOR

Patients diagnosed with hip fracture requiring surgical treatment during the study period will be screened for eligibility after providing informed consent. Eligible patients will be randomized to this group. Patients in this group will receive ultrasound-guided fascia iliaca compartment block (FICB) in the operating room immediately before surgery (conventional timing). On the day of surgery, general anesthesia (combined intravenous and inhalation) will be administered. Postoperatively, patient-controlled intravenous analgesia (PCIA) with sufentanil 1.5-2 μg/kg (total volume 100 mL, continuous dose 2 mL/h, bolus dose 2 mL, lockout interval 15 min) will be provided.

Procedure: Ultrasound-Guided Fascia Iliaca Compartment Block

Interventions

Ultrasound-Guided Fascia Iliaca Compartment Block PROCEDURE

Ultrasound-guided fascia iliaca compartment block (FICB) performed under standard cardiorespiratory monitoring. A high-frequency ultrasound transducer is placed at the lateral one-third of the line connecting the umbilicus and the anterior superior iliac spine to identify the fascia iliaca compartment. Under aseptic technique and following the principle of negative aspiration before injection, 30 mL of 0.26% liposomal bupivacaine is injected into the fascia iliaca compartment. Block efficacy is assessed 30 minutes after injection.

Also known as: FICB, Fascia Iliaca Block, Ultrasound-Guided FICB

Early Intervention Group; Non-Early Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Diagnosis of unilateral hip fracture (including femoral neck fracture or intertrochanteric fracture) confirmed by any imaging modality (X-ray, CT, or MRI)
• Scheduled for hip fracture surgery under general anesthesia with endotracheal intubation (including total hip arthroplasty, hemiarthroplasty, intertrochanteric intramedullary nail fixation, closed reduction and internal fixation, etc.)
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Able to provide written informed consent personally or via a legally authorized representative
• Able to communicate normally in Chinese

You may not qualify if:

• Known allergy to ropivacaine, bupivacaine, or liposomal bupivacaine
• Presence of any contraindication to nerve block, including but not limited to: nerve injury, coagulopathy, severe infection at the injection site, exudate at the injection site, etc.
• Pre-existing psychiatric or neurological disorders, including but not limited to: depression, severe central nervous system depression, Parkinson's disease, basal ganglia lesions, schizophrenia, epilepsy, Alzheimer's disease, myasthenia gravis
• Pre-existing severe cardiac, pulmonary, hepatic, or renal dysfunction, including but not limited to: history of heart failure, requiring dialysis, etc.
• Inability to communicate preoperatively (e.g., coma, dementia)
• Preoperative pain score \< 4 on Visual Analog Scale (VAS) or chronic/old hip fracture
• Currently participating in another interventional clinical trial
• Any other condition that, in the opinion of the investigator, would preclude evaluation of the therapeutic response or make it unlikely that the patient will complete the expected treatment course and follow-up

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Hip Fractures; Pain, Postoperative

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Saiyang Wang

CONTACT

+86 15392583362; 2574319205@qq.com

Yanhua Zhao

CONTACT

+86 18017464717

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)