Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
Patients after hip surgery often suffer from severe pain. Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications. Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery. Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection. However, its clinical advantages in hip fracture surgery remain controversial. The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years.
Scheduled to undergo hip replacement surgery.
Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).
Disqualifiers
Inability to communicate due to visual, auditory, language, or other reasons before surgery.
Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
Trial design
Design model
Parallel
Treatments tested in this trial
Liposomal bupivacaine (LB)
DrugA single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL. The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
Plain bupivacaine
DrugA single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg). The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle. The block will be performed in the preoperative holding area.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Liposomal bupivacaine groupExperimental treatment 1 intervention
Group B: Plain bupivacaine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The area under curve of pain intensity within 72 hours after surgery
Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey. The area under curve of pain intensity will be calculated using the trapezoidal rule.
Time frame
Up to 72 hours after the surgerySecondary outcomes
1
Cumulative opioid consumption within 72 hours after surgery
Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
Time frame
Up to 72 hours after the surgery2
Incidence of cardiovascular events within 7 days after surgery
Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
Time frame
Up to 7 days after surgeryOther outcomes
1
Incidence of moderate-to-severe pain within 72 hours after surgery
Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint.
Time frame
Up to 72 hours after surgery2
The proportion of patients receiving rescue analgesics within 72 hours after surgery.
Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.
Time frame
Up to 72 hours after surgery3
Cumulative score of subjective sleep quality during the first three nights after surgery
Subjective sleep quality will be assessed with the numeric rating scale (NRS; an 11-point where 0=the best sleep and 10=the worst sleep).
Time frame
Up to three nights after surgery4
Quality of recovery at 24 hours after surgery
Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluat the quality of early postoperative recovery after surgery and anesthesia. Scores range from 0 to 150, with higher scores indicating better quality of recovery).
Time frame
At 24 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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