Femoral Neck Fractures, Femur Head Necrosis, Hip Fractures
Conditions
Keywords
Bupivacaine Liposome, PENG block, Hip Arthroplasty, Randomized Controlled Trial
Brief summary
The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.
Interventions
Liposomal bupivacaine is a prolonged-release formulation of the local anesthetic bupivacaine. This intervention involves the administration of liposomal bupivacaine plus bupivacaine as a local anesthetic for the pericapsular nerve group (PENG) block under ultrasound guidance. Liposomal bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This formulation is designed to provide extended pain relief as compared to conventional bupivacaine formulations.
DRUGRopivacaine
Ropivacaine is a commonly used local anesthetic in clinical practice, and it serves as the active comparator intervention in this study. Participants in the comparator arm will receive ropivacaine as a local anesthetic for the PENG block under ultrasound guidance.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Given the distinct visual appearance of the liposomal bupivacaine (milky white) and ropivacaine (transparent), a double-blind study design is not feasible. Consequently, this study employs a single-blind approach where neither participants nor outcome assessors will be aware of treatment allocation. Healthcare providers administering the study drug will be aware of the treatment group assignment. Rigorous procedures will be implemented to minimize potential bias, including standardized outcome assessment tools, blinded data entry, and independent data analysis.
Intervention model description
This study utilizes a parallel interventional design, where participants undergoing hip arthroplasty surgery will be allocated into two separate groups. One group will receive liposomal bupivacaine plus bupivacaine as a regional anesthetic for Pericapsular Nerve Group (PENG) block, while the other group will receive ropivacaine for the same purpose. Both interventions will be administered under ultrasound guidance. The study aims to compare the analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction between the two groups, with assessments conducted at multiple time points within 72 hours post-surgery. The parallel design allows for the direct comparison of the two interventions and their respective outcomes in managing postoperative pain following hip arthroplasty.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists(ASA) I\~II * Normal coagulation * Clinical diagnosis of hip fracture
Exclusion criteria
* Presence of severe systemic diseases or ASA grade III or higher * Allergy to amide local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Opioid Consumption | this outcome will be monitored and recorded within 72 hours postoperatively | This primary outcome entails tracking and assessing the total opioid consumption by participants following hip replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | at multiple time points within 72 hours post-surgery. | Pain intensity will be assessed using the Numerical Rating Scale (NRS), a 0-10 scale where 0 represents no pain and 10 represents the worst imaginable pain. Pain intensity will be measured at 10 time points: at baseline, 30min after PENG block, at Post Anesthesia Care Unit(PACU), 6 hours, 12 hours, and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery. |
| Time to First Rescue Analgesic | 72 hours after surgery. | Time to first rescue analgesic will be recorded as the interval from the end of the surgery to the administration of the first dose of rescue analgesic medication postoperatively. |
| Incidence of Complications or Adverse Events | 90 days after the surgical procedure | This outcome focuses on monitoring and documenting any adverse events or complications that may arise as a result of the interventions, including liposomal bupivacaine and ropivacaine, during postoperative care following hip replacement surgery. The assessment involves the systematic identification, recording, and analysis of any untoward effects, adverse reactions, or complications experienced by participants attributable to the administered interventions. The aim is to evaluate the safety profile of both interventions and compare the incidence of complications between the treatment groups to ensure patient safety and well-being throughout the study period. |
| Duration of Hospital Stay | through study completion, an average of 1 year | The duration of hospital stay is a significant secondary outcome that involves recording and comparing the length of time each participant remains hospitalized following hip replacement surgery. This outcome provides insight into the postoperative recovery process and the potential impact of the administered interventions, including liposomal bupivacaine and ropivacaine, on the participants' recovery trajectory. Assessing the duration of hospitalization allows for the evaluation of factors such as pain management, mobility, and postoperative care that may influence the participants' readiness for discharge. |
Countries
China
Contacts
CONTACTXijian KE, MD
STUDY_DIRECTORWei Mei, MD
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
Outcome results
None listed