ClinicalTrials.gg
Not yet recruitingNCT07762846FICB-PREPUpdated Aug 13, 2026

FICB for Hip Fracture Pain in Elderly

An interventional study of Ultrasound-Guided Fascia Iliaca Compartment Block in Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain and QoR-15, sponsored by RenJi Hospital. Not yet recruiting at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 51 studies in Hip Fractures with a site in China — 15 open to participants now, 16 under way, none of them phase 3. Hip Fractures · China.

Planned enrollment
14th of 34
144 · median 110
Started
2026
with 4 others
No phase
26 of 51
9 open now
Primary completion
2027-12
later than 11 of 15 live
Registered
49th of 51
by date

Among the 51 studies in Hip Fractures with a site in China, this one is the 14th largest by planned enrollment of the 34 interventional ones that give a count, is one of 5 that started in 2026, is one of 26 with no phase, reaches primary completion later than 11 of the 15 other live ones, and was the 49th registered.

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

Browse Hip Fractures studies →

Open to participants now

15 of the 51 studies in Hip Fractures with a site in China are open now. Recruiting first, the newest first:

9 more — sign in →

All 15 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 104 Hip Fractures studies recruiting now, 82 (79%) set no upper age limit and 6 (6%) stop at 75 or younger; 12 take children under 18; 9 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 51 studies in Hip Fractures with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.)
  • (ASA) physical status classification I-III
  • Able to provide written personally or via a legally authorized representative
  • Able to communicate normally in Chinese

Exclusion criteria

Exclusion Criteria:

  • Known allergy to ropivacaine, bupivacaine, or liposomal bupivacaine
  • Presence of any 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    Early Intervention Group

    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

  • Active comparator
    Non-Early Intervention Group

    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

  • ProcedureUltrasound-Guided Fascia Iliaca Compartment Block

    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

06

What researchers measure

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

  5. 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.

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

  6. 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.

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

  7. Extubation Time

    Extubation time is defined as the time from the end of surgery to tracheal extubation.

    Time frame: At the end of surgery

  8. 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.

    Time frame: During PACU stay, up to 2 hours post-surgery

  9. 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.

    Time frame: Daily from the end of surgery up to hospital discharge, an average of 7 days

  10. Length of Hospital Stay

    Length of hospital stay is defined as the total number of days from hospital admission to hospital discharge.

    Time frame: From admission through hospital discharge, up to an average of 30 days

  11. 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).

    Time frame: From admission through hospital discharge, up to an average of 30 days

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2027, 16 months later.

Of 221 non-industry interventional studies with no phase under Hip Fractures, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 55. This study's planned 16 months is below that.

Counting every sponsor, half of 237 studies reached it within 29 months; a quarter within 10 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2026
First posted
Aug 13, 2026
StartEst.
Aug 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762846
Lead sponsor
RenJi Hospital
Responsible party
ZhaoYanhua (Department of Anesthesiology, RenJi Hospital) — Principal investigator
First posted
Aug 13, 2026
Start date
Aug 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Saiyang Wang
Contact
2574319205@qq.com
+86 15392583362
Yanhua Zhao
Contact
+86 18017464717

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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