Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)FICB-PREPNCT07762846
FICB for Hip Fracture Pain in Elderly
A study testing Ultrasound-Guided Fascia Iliaca Compartment Block in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures) and Postoperative Pain, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain, QoR-15
- What is being tested?
- Ultrasound-Guided Fascia Iliaca Compartment Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yanhua Zhao contact
China1 site
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: The Early Intervention of Fascia Iliaca Compartment Block (FICB) as Pain Management for Elderly Patients With Hip Fracture to Improve Postoperative Rehabilitation: A Prospective Randomized Controlled Study
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.
Read more
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
- Being tested
- Ultrasound-Guided Fascia Iliaca Compartment Block
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Fascia Iliaca Compartment BlockProcedure or surgery
Also called FICB, Fascia Iliaca Block, Ultrasound-Guided FICB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Ultrasound-Guided Fascia Iliaca Compartment Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-surgery
Secondary outcomes (11)
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.
Measured: 48 hours post-surgery
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.
Measured: From admission to 72 hours post-surgery
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.
Measured: Daily from admission up to hospital discharge, assessed up to 30 days
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.
Measured: Daily from admission up to hospital discharge, assessed up to 30 days
Sleep Duration
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.
Measured: Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
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.
Measured: Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery
Extubation Time
Extubation time is defined as the time from the end of surgery to tracheal extubation.
Measured: At the end of surgery
Incidence of Emergence Agitation
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.
Measured: During PACU stay, up to 2 hours post-surgery
Incidence of Postoperative Delirium
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.
Measured: Daily from the end of surgery up to hospital discharge, an average of 7 days
Length of Hospital Stay
Length of hospital stay is defined as the total number of days from hospital admission to hospital discharge.
Measured: From admission through hospital discharge, up to an average of 30 days
Overall Pain Management Satisfaction Score
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).
Measured: From admission through hospital discharge, up to an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)Studies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhaoYanhua, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762846
- Sponsor's protocol ID
- LY2026-057-B
- Other IDs
- IIT-2025-0528
- Acronym
- FICB-PREP
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Intervention of Fascia Iliaca Compartment Block (FICB) as Pain Management for Elderly Patients With Hip Fracture to Improve Postoperative Rehabilitation: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07762846
- Acronym / sponsor ID
- FICB-PREP / LY2026-057-B
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention Group | Experimental | Procedure: Ultrasound-Guided Fascia Iliaca Compartment BlockPatients 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. |
| Non-Early Intervention Group | Active comparator | Procedure: Ultrasound-Guided Fascia Iliaca Compartment BlockPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-Guided Fascia Iliaca Compartment BlockAlso: FICB, Fascia Iliaca Block, Ultrasound-Guided FICBUltrasound-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. | Procedure or surgery | Early Intervention Group, Non-Early Intervention Group |
Primary outcome
QoR-15 scores at 24 hours postoperatively
Time frame: 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.
11 secondary outcomes
QoR-15 score at 48 hours postoperatively
Time frame: 48 hours post-surgery
NRS score from admission to 72 hours post-surgery
Time frame: From admission to 72 hours post-surgery
Total Opioid Consumption (in Morphine Milligram Equivalents)
Time frame: Daily from admission up to hospital discharge, assessed up to 30 days
Total Non-Opioid Analgesic Consumption
Time frame: Daily from admission up to hospital discharge, assessed up to 30 days
Sleep Duration
Time frame: Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery
Sleep Quality (Pittsburgh Sleep Quality Index, PSQI)
Time frame: Daily from admission up to the day before surgery; and at 24 hours, 48 hours, and 72 hours post-surgery
Extubation Time
Time frame: At the end of surgery
Incidence of Emergence Agitation
Time frame: During PACU stay, up to 2 hours post-surgery
Incidence of Postoperative Delirium
Time frame: Daily from the end of surgery up to hospital discharge, an average of 7 days
Length of Hospital Stay
Time frame: From admission through hospital discharge, up to an average of 30 days
Overall Pain Management Satisfaction Score
Time frame: From admission through hospital discharge, up to an average of 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
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Improving Shared DECISion-making in oldEr Hip Fracture Patients Living With Frailty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanhua Zhao contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Fascia Iliaca Compartment Block in people with Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures) and Postoperative Pain, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saiyang Wang (+86 15392583362, 2574319205@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 scores at 24 hours postoperatively (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.