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Hip FracturesNCT06728033

Fascia Iliaca Compartment Block and Tramadol for Analgesia in Hip Fracture

A study testing supra-inguinal fascia iliaca compartment block and Tramadol in people with Hip Fractures and Ultrasound-guided Nerve Block, run by West China Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial summary

Hip fractures are a growing public health concern globally due to the aging population, with high incidence and significant mortality rates one year post-fracture. Effective pain management is critical to improving outcomes and accelerating recovery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
supra-inguinal fascia iliaca compartment block and Tramadol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteChina
Study dates
1 Jan 2025to 31 Dec 2027
Phase
Interventional

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a confirmed diagnosis of hip fracture
  • Aged >18 years, of any gender
  • Provide signed and dated written informed consent before formal enrollment in the study.

Who cannot join

  • Allergic to tramadol or ropivacaine
  • Unable to cooperate with the study for any reason, such as language comprehension issues, psychiatric disorders, severe hearing impairments, or communication barriers
  • Unsuitable for the trial by the investigator based on clinical judgment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: Comparison of Perioperative Analgesic Effects of Preoperative Supra-inguinal Fascia Iliaca Compartment Block and Intravenous Tramadol in Hip Fracture: A Randomized Controlled Trial

Hip fractures are a growing public health concern globally due to the aging population, with high incidence and significant mortality rates one year post-fracture. Effective pain management is critical to improving outcomes and accelerating recovery. Tramadol, a widely used intravenous analgesic, has dual opioid and non-opioid mechanisms but is associated with side effects, such as nausea, dizziness, and respiratory depression, necessitating careful monitoring in hip fracture patients.

The supra-inguinal fascia iliaca compartment block (SiFICB) offers a promising alternative, targeting key nerves to achieve effective analgesia through ultrasound-guided delivery of local anesthetics. SiFICB minimizes side effects and improves pain control by accurately blocking the femoral, lateral femoral cutaneous, and obturator nerves. While its postoperative benefits are well-documented, its efficacy in managing preoperative pain from hip fractures remains underexplored.

This study hypothesizes that ultrasound-guided SiFICB provides superior perioperative analgesia compared to intravenous tramadol. A prospective randomized controlled trial will evaluate the analgesic efficacy of SiFICB, using the numerical rating scale (NRS) to assess pain, aiming to improve the management of hip fracture-related pain and patient outcomes.

Read the detailed description

Background With the global aging population, the incidence of hip fractures continues to rise. In the United States, over 300,000 cases occur annually among individuals aged 65 years or older. The incidence of hip fractures in Europe ranges between 307 and 1269 per 100,000 population. Mortality rates one year after a hip fracture are alarmingly high, ranging from 19.7% to 34.8%, making hip fractures a significant public health issue. It is estimated that the global number of hip fracture cases will increase to 2.6-7.3 million by 2025 and 4.5-21.3 million by 2050 . Optimizing treatment pathways for hip fractures, promoting accelerated postoperative recovery, and improving patient outcomes are therefore critical.

Early pain management intervention can alleviate pain, reduce anxiety, improve sleep, and significantly decrease complications and mortality associated with hip fractures . Currently, intravenous tramadol is a commonly used analgesic. Tramadol, a synthetic opioid, acts as a μ-opioid receptor agonist with weak affinity and inhibits serotonin (5-HT) and norepinephrine (NE) reuptake, exerting dual analgesic effects . It is increasingly replacing high-affinity opioids for the treatment of moderate-to-severe acute and chronic pain globally. However, tramadol has adverse effects, including sweating, dizziness, nausea, vomiting, appetite loss, urinary retention, and risks of addiction, misuse, and respiratory depression. Its use in hip fracture patients requires close monitoring to manage adverse effects promptly.

The pain associated with hip fractures arises from noxious stimulation of free nerve endings transmitting nociceptive and proprioceptive signals. The nerves innervating the hip skin originate from the lumbar plexus, including the femoral nerve and lateral femoral cutaneous nerve. The anterior hip joint capsule receives sensory input from the femoral and obturator nerves. Pain receptors in the anterior capsule are most densely distributed in the superior portion, while they are sparse in the posterior capsule and ligaments surrounding the hip joint.

Based on this anatomical understanding, a Supra-inguinal fascia iliaca compartment block (SiFICB) above the inguinal ligament can effectively block the femoral and lateral femoral cutaneous nerves. The spread of local anesthetics medially in the fascia iliaca compartment can also block the obturator nerve, achieving analgesia. However, fascia iliaca blocks can have adverse effects, including inadequate localization leading to poor efficacy, quadriceps weakness due to femoral nerve blockade, and local anesthetic toxicity. Ultrasound guidance can ensure accurate delivery of local anesthetics into the fascia iliaca compartment, allowing for lower concentrations and reduced adverse effects. Although studies have reported the efficacy of ultrasound-guided fascia iliaca blocks for postoperative pain relief after hip surgeries , their impact on preoperative pain caused by fracture displacement or friction of fracture ends remains underexplored.

The investigators hypothesize that an ultrasound-guided SiFICB above the inguinal ligament provides superior perioperative analgesia compared with intravenous tramadol, the current standard of care in orthopedic trauma. To test this hypothesis, the investigators design a prospective randomized controlled trial in patients undergoing hip fracture surgery, using the numerical rating scale (NRS) as the primary outcome to assess pain, to evaluate the perioperative analgesic efficacy of ultrasound-guided SiFICB by comparison to intravenous tramadol in patients with hip fractures.

Being tested
supra-inguinal fascia iliaca compartment block, Tramadol
Keywords
Hip Fractures, Supra-inguinal Fascia Iliaca compartment Block, Tramadol
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • supra-inguinal fascia iliaca compartment blockOther

    Supra-inguinal fascia iliaca compartment block with 40 ml of 0.25% ropivacaine

  • TramadolDrug

    intravenous tramadol at a dose of 2 mg/kg

Study groups in NCT06728033
Study groupRoleWhat they receive
SiFICB GroupExperimentalParticipants will receive an ultrasound-guided SiFICB above the inguinal ligament with 40 ml of 0.25% ropivacaine.
Receives: Other: supra-inguinal fascia iliaca compartment block
Tramadol GroupActive comparatorParticipants will receive intravenous tramadol at a dose of 2 mg/kg
Receives: Drug: Tramadol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resting numerical rating scale (NRS) pain scores preoperatively

    The Numerical Rating Scale (NRS) is a tool for assessing pain intensity, allowing patients to rate their pain on a scale from 0 to 10, where 0 represents "no pain," 10 represents "the worst pain imaginable," and pain levels are categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).

    Measured: 7 days postperatively

Secondary outcomes (8)
  1. Incidence of severe complications

    Mortality and the overall incidence of severe complications are classified into five grades: Grade I (fully resolved with temporary treatment, e.g., postoperative nausea and vomiting), Grade II (prolonged hospital stay required, e.g., pneumonia requiring antibiotic treatment), Grade III (life-threatening events requiring intervention with recovery during hospitalization, e.g., deep vein thrombosis), Grade IV (significant long-term harm, e.g., postoperative cognitive dysfunction), and Grade V (death within 30 days postoperatively).

    Measured: 7 days postperatively

  2. Resting NRS pain scores postoperatively

    Resting NRS pain scores on postoperative days 1, 2, and 3

    Measured: 3 days after surgery

  3. Movement NRS pain scores postoperatively

    Movement NRS pain scores on postoperative days 1, 2, and 3

    Measured: 3 days after surgery

  4. Total perioperative morphine consumption

    Morphine is used as a rescue measure for acute pain. When a patient's resting NRS pain score exceeds 4, 5 mg of morphine can be administered intravenously. If the effect is insufficient, an additional 5 mg may be given after 30 minutes, with a maximum daily dose of 20 mg.

    Measured: 7 days postperatively

  5. Time to initiation of functional exercise

    Duration from admission to the first mobilization, pre- or postoperatively (days)

    Measured: 30 days postperatively

  6. Total length of hospital stay

    Duration from admission to discharge (days)

    Measured: 30 days postperatively

  7. Postoperative hospital stay

    Duration from surgery to discharge (days)

    Measured: 30 days postperatively

  8. Total hospitalization costs

    Total hospitalization costs

    Measured: 7 days after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728033
Sponsor's protocol ID
WCH20241201
Status last verified
Dec 2024
First submitted
1 Dec 2024
Last updated
11 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared after de-identification.The shared data will include de-identified individual participant data, and metadata supporting the primary and secondary outcomes, as well as the study protocol.Data will be available beginning 6 months after publication of the main study results and ending 3 years following publication. Requests for data sharing should be directed to the corresponding author (liaoren7733@163.com). Upon approval of a formal proposal, a data-sharing agreement will be signed, and access will be granted through a secure data-sharing platform.

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