Comparison of Standard PENG Block Versus PENG With Perineural Dexamethasone or Perineural Dexmedetomidine in Patients Aged 65 Years and Older Undergoing Hip Surgery: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Poznan University of Medical Sciences
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Time to First Rescue Analgesia
概览
简要总结
This study will compare three versions of the Pericapsular Nerve Group (PENG) block in adults aged 65 years and older who are undergoing hip surgery. The PENG block is a regional anesthesia technique used to reduce pain around the hip joint and may improve early recovery after surgery.
All patients in the study will receive the PENG block using 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:
Group 1: PENG block using ropivacaine only (no additional medications). Group 2: PENG block using ropivacaine with 4 mg of dexamethasone injected near the nerves.
Group 3: PENG block using ropivacaine with 25 micrograms of dexmedetomidine injected near the nerves.
Dexamethasone and dexmedetomidine are medications that may increase the duration and quality of regional anesthesia. It is not known whether adding one of these medications provides longer-lasting or better pain relief compared to using ropivacaine alone.
The main purpose of this study is to determine whether the addition of dexamethasone or dexmedetomidine improves the effectiveness of the PENG block in relieving pain after hip surgery. The study will evaluate pain levels, opioid consumption, time to first rescue pain medication, need for additional analgesia, and recovery outcomes. Safety, side effects, and any block-related complications will also be monitored.
The investigators hypothesize that adding either perineural dexamethasone or dexmedetomidine will result in longer and more effective pain relief compared with the standard PENG block without an adjuvant.
This research may help identify the most effective form of the PENG block for older adults undergoing hip surgery and contribute to improved pain management, reduced opioid use, and better postoperative recovery.
详细描述
Hip surgery in older adults is frequently associated with significant postoperative pain, delayed mobilization, and increased opioid requirements. Poor pain control in this population can lead to complications such as delirium, prolonged hospitalization, reduced physical function, and slower rehabilitation. Effective regional anesthesia may improve safety and recovery after hip surgery.
The Pericapsular Nerve Group (PENG) block is a relatively new regional anesthesia technique designed to target the sensory innervation of the hip joint while preserving motor function. This motor-sparing feature may allow earlier mobilization and reduce the negative effects of immobilization in older patients.
Ropivacaine is the standard local anesthetic commonly used in peripheral nerve blocks. Small doses of adjuvant medications such as dexamethasone or dexmedetomidine may prolong the duration of analgesia and improve the quality of pain control. However, it remains unclear whether the addition of these medications provides any clinically meaningful benefit when used with the PENG block in older adults. There is also limited evidence directly comparing different adjuvants to a standard PENG block without additional medication.
This randomized controlled trial will compare three variants of the PENG block in adults aged 65 years and older undergoing hip surgery. All participants will receive a PENG block with 20 mL of 0.2% ropivacaine. They will then be randomly assigned to one of three groups:
Standard PENG block with ropivacaine alone (no adjuvant). PENG block with 4 mg of perineural dexamethasone. PENG block with 25 micrograms of perineural dexmedetomidine. All patients will receive standard perioperative care and multimodal analgesia. The study will assess pain scores, time to first rescue analgesia, total opioid consumption, functional mobility, incidence of postoperative nausea and vomiting, block duration, motor function, and complications. Safety will also be monitored, including block-related and neurological adverse events.
The primary objective of this study is to determine whether perineural dexamethasone or dexmedetomidine improves postoperative analgesia compared with a standard PENG block without adjuvant. The investigators hypothesize that both adjuvants may prolong analgesia and reduce opioid requirements, but their effectiveness and safety profile may differ.
This study aims to provide evidence that can help guide anesthesiologists in selecting the optimal variant of the PENG block for older adults undergoing hip surgery, intending to improve postoperative pain control, support early rehabilitation, and reducing complications associated with opioid use and delayed mobilization.
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)
盲法说明
Study medications will be prepared by a clinician not involved in patient care or outcome assessment. All participants will receive identical appearing syringes and identical volumes of perineural and intravenous solutions containing either active medication or normal saline placebo. Patients, care providers, investigators, and outcome assessors will remain blinded to group allocation.
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
- •Planned use of a PENG block as part of perioperative analgesia
- •Ability to communicate pain intensity using the NRS scale
- •Written informed consent obtained from the patient or legal representative
排除标准
- •Refusal or inability to provide informed consent
- •Known allergy, intolerance, or contraindication to any of the study medications: ropivacaine, dexamethasone, dexmedetomidine
- •Pre-existing neurological deficit or neuropathy in the affected limb
- •Coagulopathy or laboratory abnormality that contraindicates regional anesthesia: INR \>1.5, or platelet count \<100,000/µL, or therapeutic anticoagulation that cannot be safely paused
- •Infection at or near the needle insertion site
- •Severe hepatic or renal impairment
- •Chronic opioid therapy (\>30 days of daily opioids before surgery)
- •Cognitive impairment or delirium that prevents reliable pain assessment
- •BMI \>40 kg/m² (due to potential technical difficulty and reduced accuracy of ultrasound guidance)
- •Previous regional block affecting the target area for the current surgery
研究组 & 干预措施
PENG Block With Ropivacaine Only (Control)
Participants will receive a Pericapsular Nerve Group (PENG) block using 20 mL of 0.2% ropivacaine without any adjuvant administered perineurally or intravenously. All participants will receive standard perioperative care and multimodal analgesia. Ondansetron will be used as standard prophylaxis for postoperative nausea and vomiting.
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
PENG Block With Perineural Dexamethasone
Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 4 mg of dexamethasone administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
干预措施: Dexamethasone 4mg (Drug)
PENG Block With Perineural Dexmedetomidine
Participants will receive a PENG block using 20 mL of 0.2% ropivacaine combined with 25 µg of dexmedetomidine administered perineurally. No dexamethasone will be given intravenously. All participants will receive standard perioperative care and multimodal analgesia.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Time to First Rescue Analgesia
时间窗: Within 48 hours after surgery.
Time (in hours) from completion of the PENG block to the first administration of a rescue analgesic (opioid or non-opioid) given for pain intensity ≥4 on the 0-10 Numerical Rating Scale (NRS).
次要结局
- Incidence of Postoperative Nausea and Vomiting (PONV)(0-48 hours after surgery.)
- Pain Intensity at Rest (NRS 0-10)(48 hours after surgery.)
- Total Opioid Consumption(0-24 hours and 0-48 hours after surgery.)
- Block-Related Adverse Events, Including Neurological Complications(From block placement until 30 days after surgery.)
- Pain Intensity During Movement (NRS 0-10)(48 hours after surgery.)
- Motor Function Preservation (Quadriceps Strength, MRC Scale)(48 hours after surgery.)
- Hemodynamic Adverse Events(From block placement until 24 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.)