FICB for Hip Fracture Pain in Elderly

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorRenJi Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-Guided Fascia Iliaca Compartment Block

    Procedure/Surgery

    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.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Early Intervention GroupExperimental treatment 1 intervention
Group B: Non-Early Intervention GroupActive comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours post-surgery

Secondary outcomes

1

QoR-15 score at 48 hours postoperatively

QoR-15 score used to evaluate the effect of early intervention with liposomal bupivacaine for fascia iliaca compartment block on improving 48-hour postoperative quality of recovery in patients undergoing hip fracture surgery.

Time frame
48 hours post-surgery
2

NRS score from admission to 72 hours post-surgery

Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain. Assessments will be performed at the following time points: (1) daily from hospital admission until the day before surgery (up to 7 days); (2) immediately upon arrival in the operating room (pre-surgery); and (3) at 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3) post-surgery.

Time frame
From admission to 72 hours post-surgery
3

Total Opioid Consumption (in Morphine Milligram Equivalents)

Total opioid consumption will be recorded from hospital admission to hospital discharge. All opioid doses will be converted to intravenous morphine milligram equivalents (MMEs) for standardization and summed for each patient.

Time frame
Daily from admission up to hospital discharge, assessed up to 30 days
4

Total Non-Opioid Analgesic Consumption

Total consumption of non-opioid analgesics, including acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and other rescue analgesics, will be recorded from hospital admission to hospital discharge. All doses will be documented and summed for each patient.

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

Other outcomes

Sponsors and contacts

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