Health TrialsbyHealthPanel

Fascia Iliaca Compartment Block and Tramadol for Analgesia in Hip Fracture

ConditionsHip FracturesUltrasound-guided Nerve BlockPerioperative Analgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • supra-inguinal fascia iliaca compartment block

    Other intervention

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

  • Tramadol

    Drug

    intravenous tramadol at a dose of 2 mg/kg

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: SiFICB GroupExperimental treatment 1 intervention
Group B: Tramadol GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
7 days postperatively

Secondary outcomes

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).

Time frame
7 days postperatively
2

Resting NRS pain scores postoperatively

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

Time frame
3 days after surgery
3

Movement NRS pain scores postoperatively

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

Time frame
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.

Time frame
7 days postperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: