Elderly, Fascia Iliaca Block, Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain, QoR-15, Recovery of Function (G11.427.698.620)
Conditions
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.
Interventions
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.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR-15 scores at 24 hours postoperatively | 24 hours post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption (in Morphine Milligram Equivalents) | Daily from admission up to hospital discharge, assessed up to 30 days | 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. |
| Total Non-Opioid Analgesic Consumption | Daily from admission up to hospital discharge, assessed up to 30 days | 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. |
| Sleep Duration | Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery | Total sleep time in hours per 24-hour period, documented by patient diary. Sleep duration will be recorded daily from admission until the day before surgery, and at 24 hours, 48 hours, and 72 hours post-surgery. |
| Sleep Quality (Pittsburgh Sleep Quality Index, PSQI) | Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery | Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-rated questionnaire. The global PSQI score ranges from 0 to 21, with higher scores indicating worse sleep quality (a global score \>5 indicates poor sleep quality). PSQI will be measured at the following time points: daily from admission until the day before surgery; and 24 hours, 48 hours, and 72 hours post-surgery. |
| Extubation Time | At the end of surgery | Extubation time is defined as the time from the end of surgery to tracheal extubation. |
| Incidence of Emergence Agitation | During PACU stay, up to 2 hours post-surgery | Emergence agitation (EA) is defined as a state of agitation, confusion, disorientation, and/or hyperactivity during the transition from unconsciousness to full wakefulness in the post-anesthesia care unit (PACU). The incidence of EA will be recorded as the proportion of patients who develop EA during the PACU stay. |
| QoR-15 score at 48 hours postoperatively | 48 hours post-surgery | 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. |
| Incidence of Postoperative Delirium | Daily from the end of surgery up to hospital discharge, an average of 7 days | Postoperative delirium (POD) will be assessed daily from the end of surgery until hospital discharge. Delirium will be diagnosed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) for non-ICU patients or the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for patients requiring intensive care. Both tools are validated versions of the original CAM algorithm. The diagnosis of delirium requires: (1) acute onset or fluctuating course, (2) inattention, and (3) either disorganized thinking or altered level of consciousness. The incidence of POD will be reported as the proportion of patients who experience at least one episode of delirium during the postoperative hospitalization period. |
| Length of Hospital Stay | From admission through hospital discharge, up to an average of 30 days | Length of hospital stay is defined as the total number of days from hospital admission to hospital discharge. |
| NRS score from admission to 72 hours post-surgery | 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. |
| Overall Pain Management Satisfaction Score | From admission through hospital discharge, up to an average of 30 days | Overall satisfaction with pain management will be assessed at hospital discharge using a validated satisfaction scale. Degree of patient satisfaction will be assessed on a 5-point Likert scale (1=extremely dissatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=extremely satisfied). |
Countries
China
Contacts
CONTACTSaiyang Wang
CONTACTYanhua Zhao
Outcome results
None listed