Safety and Efficacy of Dexamethasone Versus Dexmedetomidine as Adjuvants in PENG Block in Hip Surgeries for Postoperative Pain Management
Safety and Efficacy of Dexamethasone Versus Dexmedetomidine as Adjuvants in Pericapsular Nerve Group (PENG) Block in Hip Surgeries for Postoperative Pain Management
This study evaluates and compares the analgesic efficacy and safety of adding dexamethasone versus dexmedetomidine to bupivacaine in an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block in patients undergoing elective total hip replacement under spinal anesthesia.
Total hip replacement is associated with substantial acute postoperative pain. The PENG block targets sensory articular branches supplying the hip while preserving quadriceps muscle strength, facilitating early postoperative ambulation. Supplementation with an LFCN block expands sensory coverage to the lateral surgical incision. Adding perineural adjuvants, such as dexamethasone or dexmedetomidine, to local anesthetics may prolong sensory block duration and reduce opioid requirements.
A total of 90 adult participants aged 18 to 60 years will be randomly assigned to one of three equal groups (30 patients each):
- Group C (Control): Receives a PENG block with 20 mL of plain bupivacaine 0.25%.
- Group DX: Receives a PENG block with 20 mL of bupivacaine 0.25% combined with dexamethasone 4 mg.
- Group DM: Receives a PENG block with 20 mL of bupivacaine 0.25% combined with dexmedetomidine 1 µg/kg.
All participants across all groups will receive an LFCN block with 5 mL of plain bupivacaine 0.25% without adjuvants.
The primary outcome is the time to the first request for rescue analgesia (duration of postoperative analgesia). Secondary outcomes include total morphine consumption over the first 24 hours, pain intensity measured using the Visual Analogue Scale (VAS), intraoperative and postoperative hemodynamic stability, sedation levels, quality of recovery assessed at 24 hours via the Quality of Recovery-15 (QoR-15) questionnaire, and the incidence of any adverse effects or block-related complications.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged 18 to 60 years.
- American Society of Anesthesiologists (ASA) physical status class I or II.
- Scheduled for elective unilateral total hip replacement under spinal anesthesia.
Exclusion Criteria:
- Patient refusal of the peripheral nerve block.
- Infection at the site of injection.
- Coagulopathy or contraindication to spinal anesthesia.
- Known allergy or hypersensitivity to any of the study medications.
- Baseline bradycardia or significant cardiac conduction abnormality.
- Chronic opioid use or pre-existing chronic pain on regular analgesics.
- Patients unable to communicate or reliably express pain scores.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Group C (Control)
Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using 20 mL of plain bupivacaine 0.25% alone, followed by a lateral femoral cutaneous nerve (LFCN) block using 5 mL of plain bupivacaine 0.25% without adjuvant. |
Plain bupivacaine 0.25% (20 mL) administered perineurally via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for Lateral Femoral Cutaneous Nerve (LFCN) block without adjuvant. |
|
实验性的：Group DX (Dexamethasone)
Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using bupivacaine 0.25% with dexamethasone 4 mg added (total volume 20 mL), followed by an LFCN block using 5 mL of plain bupivacaine 0.25% without adjuvant. |
Plain bupivacaine 0.25% (20 mL) administered perineurally via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for Lateral Femoral Cutaneous Nerve (LFCN) block without adjuvant. Perineural dexamethasone 4 mg combined with bupivacaine 0.25% to an identical total volume of 20 mL, administered via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for LFCN block. |
|
实验性的：Group DM (Dexmedetomidine)
Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using bupivacaine 0.25% with dexmedetomidine 1 µg/kg added (total volume 20 mL), followed by an LFCN block using 5 mL of plain bupivacaine 0.25% without adjuvant. |
Plain bupivacaine 0.25% (20 mL) administered perineurally via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for Lateral Femoral Cutaneous Nerve (LFCN) block without adjuvant. Perineural dexmedetomidine 1 µg/kg combined with bupivacaine 0.25% to an identical total volume of 20 mL, administered via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for LFCN block. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to First Request for Rescue Analgesia (Hours)
大体时间：Up to 24 hours postoperatively
|
Duration of postoperative analgesia in hours, measured from the completion of the nerve block to the patient's first request for rescue analgesia (intravenous morphine PCA triggered for VAS score of 3 or greater). If a patient does not request analgesia within the observation period, data will be censored at 24 hours. |
Up to 24 hours postoperatively
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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