Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)
- Conditions
- Hip FracturesFemoral Neck FracturesFemur Head Necrosis
- Interventions
- Drug: Liposomal bupivacaine plus bupivacaine
- Registration Number
- NCT06565910
- Lead Sponsor
- Huazhong University of Science and Technology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- American Society of Anesthesiologists(ASA) I~II
- Normal coagulation
- Clinical diagnosis of hip fracture
- Presence of severe systemic diseases or ASA grade III or higher
- Allergy to amide local anesthetics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liposomal Bupivacaine plus Bupivacaine Intervention Liposomal bupivacaine plus bupivacaine Participants in this arm will receive liposomal bupivacaine(LB) plus bupivacaine(B) as a local anesthetic for PENG block under ultrasound guidance. Liposomal bupivacaine plus bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of liposomal bupivacaine plus bupivacaine compared to the standard local anesthetic, ropivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery. Ropivacaine Intervention Ropivacaine Participants in this arm will receive ropivacaine (R) as a local anesthetic for the PENG block under ultrasound guidance. Ropivacaine, a routinely used local anesthetic in clinical practice, is being compared to liposomal bupivacaine plus bupivacaine to assess its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of ropivacaine in comparison to the investigational intervention, liposomal bupivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, HUST
🇨🇳Wuhan, Hubei, China