Comparison of Three Variants of PENG Block Using 20 mL of 0.2% Ropivacaine With Different Combinations of Dexamethasone and Perineural Dexmedetomidine in Patients Aged 65 Years and Older Undergoing Hip Surgery: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to First Rescue Analgesia
研究概览
简要总结
This study will compare three different versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing surgery for hip conditions. The PENG block is a regional anesthesia technique that can reduce pain after surgery and decrease the need for strong opioid pain medications.
All patients in the study will receive the PENG block with 20 mL of 0.2% ropivacaine, but they will be divided into three groups based on the additional medications used:
Group 1: PENG block with ropivacaine plus 4 mg of dexamethasone given intravenously.
Group 2: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously.
Group 3: PENG block with ropivacaine plus 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves.
Both dexmedetomidine and dexamethasone are medications that may improve the strength and duration of nerve blocks.
The main goal of this study is to determine which combination provides the best pain control after hip surgery, reduces the need for opioid medications, and improves patient comfort and recovery. We also aim to evaluate the safety and side-effects of each technique.
We hypothesize that adding both dexmedetomidine and dexamethasone near the nerves will provide the longest and most effective pain relief when compared to intravenous administration alone.
This trial may help identify the most effective PENG block formula for older adults undergoing hip surgery and could improve pain management, decrease complications related to opioids, and support faster recovery.
详细描述
Hip surgery in older adults is commonly associated with significant postoperative pain. Effective pain control is very important in this population because poorly controlled pain may lead to complications such as delayed rehabilitation, increased opioid use, delirium, and longer hospital stay. The Pericapsular Nerve Group (PENG) block is a modern regional anesthesia technique that targets nerves responsible for hip pain while preserving muscle strength around the hip. This may help patients recover faster and walk earlier after surgery.
Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of nerve blocks. Dexamethasone can be given either intravenously or near the nerves. Dexmedetomidine can also be given near the nerves in low doses to prolong pain relief. However, it is still unknown which combination of these medications with the PENG block provides the best results for older patients.
This study will compare three different versions of the PENG block in patients aged 65 years and older who are undergoing hip surgery. All participants will receive 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups depending on the additional medications they receive:
Group 1: PENG block with 4 mg of dexamethasone given intravenously. Group 2: PENG block with 25 micrograms of dexmedetomidine given near the nerves and 4 mg of dexamethasone given intravenously.
Group 3: PENG block with 25 micrograms of dexmedetomidine and 4 mg of dexamethasone given near the nerves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Scheduled for elective or emergency hip surgery (e.g., hip fracture fixation or hip arthroplasty)
- •ASA physical status I-III
- •Ability to communicate pain intensity using the NRS scale
- •Written informed consent obtained from the patient or legal representative
- •Planned use of PENG block as part of multimodal perioperative analgesia
排除标准
- •Patient refusal or inability to provide informed consent
- •Allergy, intolerance, or contraindication to any study medication: ropivacaine, dexamethasone, dexmedetomidine
- •Pre-existing neurological deficit or neuropathy of the affected limb
- •Coagulopathy (INR >1.5, platelets <100,000/µL) or current therapeutic anticoagulation that contraindicates regional anesthesia
- •Infection at or near the injection site
- •Severe hepatic or renal impairment
- •History of chronic opioid use (daily opioids >30 days before surgery)
- •Cognitive impairment or delirium precluding reliable pain assessment
- •BMI > 40 kg/m² (if you want to exclude for technical difficulty)
- •Patients receiving another regional nerve block for hip surgery
- •Pregnancy or breastfeeding
- •Participation in another interventional clinical trial within 30 days
研究组 & 干预措施
PENG Block With Intravenous Dexamethasone
Participants will receive a Pericapsular Nerve Group (PENG) block using 20 mL of 0.2% ropivacaine. As part of the study medications, they will receive 4 mg of dexamethasone intravenously and perineural normal saline as placebo, so that the number and volume of injections are identical across all groups.
干预措施: Dexamethasone (intravenous) (Drug)
PENG Block With Perineural Dexmedetomidine and Intravenous Dexamethasone
Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine administered perineurally. In addition, they will receive 4 mg of dexamethasone intravenously. Perineural normal saline may be added to match the total volume of perineural injectate across groups.
干预措施: Dexamethasone (intravenous) with Dexmedetomidine (perineural) (Drug)
PENG Block With Perineural Dexmedetomidine and Perineural Dexamethasone
Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine and 4 mg of dexamethasone administered perineurally. Intravenously they will receive normal saline as placebo instead of dexamethasone in order to maintain blinding.
干预措施: Dexamethasone (perineural) with Dexmedetomidine (perineural) (Drug)
结局指标
主要结局
Time to First Rescue Analgesia
时间窗: Within 48 hours after the end of surgery
Time (in hours) from the end of the PENG block (completion of local anesthetic injection) to the first administration of rescue analgesia (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS). Data will be collected from anesthesia records and postoperative medication charts.
次要结局
- Pain Intensity During Movement (NRS 0-10)(48 hours after surgery)
- Pain Intensity at Rest (NRS 0-10)(48 hours after surgery)
- Total Opioid Consumption(0-48 hours after surgery)
- Incidence of Postoperative Nausea and Vomiting (PONV)(0-48 hours after surgery)
- Hemodynamic Adverse Events (Hypotension and Bradycardia)(From block placement until 24 hours after surgery)
- Block-Related Adverse Events, Including Neurological Complications(From block placement until hospital discharge, up to 30 days)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(48 hours after surgery)
- Pain Intensity at Rest (NRS 0-10)(4 hours after surgery)
- Pain Intensity at Rest (NRS 0-10)(8 hours after surgery)
- Pain Intensity at Rest (NRS 0-10)(12 hours after surgery)
- Pain Intensity at Rest (NRS 0-10)(24 hours after surgery)
- Pain Intensity During Movement (NRS 0-10)(4 hours after surgery)
- Pain Intensity During Movement (NRS 0-10)(8 hours after surgery)
- Pain Intensity During Movement (NRS 0-10)(12 hours after surgery)
- Pain Intensity During Movement (NRS 0-10)(24 hours after surgery)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(4 hours after surgery)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(8 hours after surgery)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(12 hours after surgery)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(24 hours after surgery)