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.
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
- Conditions the study is for
- Hip Fractures, Ultrasound-guided Nerve Block, Perioperative Analgesia
- 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
- 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 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.
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 group | Role | What they receive |
|---|---|---|
| SiFICB Group | Experimental | Participants 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 Group | Active comparator | Participants 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.
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)
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
Resting NRS pain scores postoperatively
Resting NRS pain scores on postoperative days 1, 2, and 3
Measured: 3 days after surgery
Movement NRS pain scores postoperatively
Movement NRS pain scores on postoperative days 1, 2, and 3
Measured: 3 days after surgery
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
Time to initiation of functional exercise
Duration from admission to the first mobilization, pre- or postoperatively (days)
Measured: 30 days postperatively
Total length of hospital stay
Duration from admission to discharge (days)
Measured: 30 days postperatively
Postoperative hospital stay
Duration from surgery to discharge (days)
Measured: 30 days postperatively
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.
- First posted11 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by West China 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ren Liao, West China Hospital
- Investigators
- Ren Liao, M.D., Principal investigator, West China Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06728033
- Acronym / sponsor ID
- WCH20241201
- Keywords
- Hip Fractures, Supra-inguinal Fascia Iliaca compartment Block, Tramadol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Dec 2024 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SiFICB Group | Experimental | Other: supra-inguinal fascia iliaca compartment blockParticipants will receive an ultrasound-guided SiFICB above the inguinal ligament with 40 ml of 0.25% ropivacaine. |
| Tramadol Group | Active comparator | Drug: TramadolParticipants will receive intravenous tramadol at a dose of 2 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| supra-inguinal fascia iliaca compartment blockSupra-inguinal fascia iliaca compartment block with 40 ml of 0.25% ropivacaine | Other | SiFICB Group |
| Tramadolintravenous tramadol at a dose of 2 mg/kg | Drug | Tramadol Group |
Primary outcome
Resting numerical rating scale (NRS) pain scores preoperatively
Time frame: 7 days postperatively
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).
8 secondary outcomes
Incidence of severe complications
Time frame: 7 days postperatively
Resting NRS pain scores postoperatively
Time frame: 3 days after surgery
Movement NRS pain scores postoperatively
Time frame: 3 days after surgery
Total perioperative morphine consumption
Time frame: 7 days postperatively
Time to initiation of functional exercise
Time frame: 30 days postperatively
Total length of hospital stay
Time frame: 30 days postperatively
Postoperative hospital stay
Time frame: 30 days postperatively
Total hospitalization costs
Time frame: 7 days after discharge
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 11 Dec 2024.
- Individual participant dataSharing planned: 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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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.
Ren Liao, M.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 3 inclusion and 3 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 11 Dec 2024. 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 Ren Liao, M.D. (+86-18980602177, liaoren7733@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting numerical rating scale (NRS) pain scores preoperatively (time frame: 7 days postperatively). 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 11 Dec 2024.