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临床试验 NCT07502248 针对术后疼痛，Total Hip Arthroplasty (THA)目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
PENG Block With or Without PPD Block for Postoperative Analgesia After Total Hip Arthroplasty 40 随机化
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临床试验NCT07502248是一项针对术后疼痛，Total Hip Arthroplasty (THA)的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年4月5日开始，预计招募40名患者。该研究由Kirsehir Ahi Evran Universitesi主导，计划于2027年6月5日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月30日。
简要概括
This single-center, prospective, randomized controlled clinical trial aims to compare the postoperative analgesic efficacy of PENG block with or without posterior pericapsular deep gluteal block in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Total hip arthroplasty is commonly associated with moderate to severe postoperative pain. Although PENG block provides analgesia fo...显示更多
详细描述
This study is planned as a single-center, prospective, randomized, controlled, double-blind trial in adult patients undergoing elective primary total hip arthroplasty under spinal anesthesia. Eligible participants will be patients aged 18 years or older, classified as ASA physical status I-III, and able to provide informed consent. Patients with ASA IV-V, serious cardiac, respiratory, hepatic, or renal disease, neuro...显示更多
官方标题
Comparison of the Efficacy of Pericapsular Nerve Group (PENG) Block Versus PENG Block Added to Posterior Pericapsular Deep Gluteal (PPD) Block for Postoperative Analgesia in Total Hip Arthroplasty
疾病
术后疼痛Total Hip Arthroplasty (THA)其他研究标识符
- KAEAH-THA-PENG-PPD-01
NCT编号
实际开始日期
2026-04-05
最近更新发布
2026-03-30
预计完成日期
2027-06-05
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
关键词
PENG block
PPD block
Postoperative analgesia
Numeric Rating Scale
PPD block
Postoperative analgesia
Numeric Rating Scale
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照PENG Block Participants in this arm will receive ultrasound-guided PENG block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty. In addition, lateral femoral cutaneous nerve block will be performed. | PENG阻滞 Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be ...显示更多 |
阳性对照PENG Plus PPD Block Participants in this arm will receive ultrasound-guided PENG block followed by ultrasound-guided posterior pericapsular deep gluteal block after spinal anesthesia for postoperative analgesia during primary total hip arthroplasty. In addition, lateral femoral cutaneous nerve block will be performed. | PENG阻滞 Ultrasound-guided pericapsular nerve group block performed after spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 1, PENG block will be performed in the supine position using an in-plane technique, and 20 mL of 0.25% bupivacaine will be injected between the psoas tendon and iliopubic ramus. In both groups, lateral femoral cutaneous nerve block will also be ...显示更多 Deep posterior gluteal compartment block Ultrasound-guided posterior pericapsular deep gluteal block performed after PENG block and spinal anesthesia for postoperative analgesia in patients undergoing primary total hip arthroplasty. In Group 2, the block will be performed in the lateral decubitus position with the hip and knee flexed to 90 degrees, and 30 mL of 0.25% bupivacaine will be injected after needle placement to the posterior acetabular rim near th...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Postoperative pain intensity at 6 hours measured by Numeric Rating Scale (NRS) | Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison between groups will be the NRS score at postoperative 6 hours | 6 hours after surgery |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Postoperative pain intensity over the first 24 hours measured by Numeric Rating Scale (NRS) | Postoperative pain intensity will also be assessed in the recovery room and at postoperative 2, 12, and 24 hours using the Numeric Rating Scale (NRS) | Recovery room, 2 hours, 12 hours, and 24 hours after surgery |
Total analgesic consumption during the first 24 hours | Total amount of analgesic medication consumed within the first 24 hours after surgery will be recorded and compared between groups | 24 hours after surgery |
Time to first rescue analgesic requirement | Time from block performance to first additional analgesic requirement will be recorded | Up to 24 hours after surgery |
Time to first mobilization | Time to first standing or mobilization after surgery will be recorded and compared between groups | Up to 24 hours after surgery |
Ankle dorsiflexion motor strength | Ankle dorsiflexion motor strength will be assessed postoperatively to evaluate possible motor weakness related to block spread. | Recovery room, 2 hours, 6 hours, 12 hours, and 24 hours after surgery |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Adults aged 18 years and older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled for elective primary total hip arthroplasty under spinal anesthesia
- Able to provide written informed consent
- ASA physical status IV or V
- Serious concomitant cardiac, respiratory, hepatic, or renal disease
- Known neuropsychiatric disorder
- Cognitive impairment preventing understanding or response to the Numeric Rating Scale (NRS)
- Coagulopathy
- Local anesthetic allergy
- Infection or scar at the block site
- Failed block
- Refusal to participate
- Signs of local anesthetic systemic toxicity after block
- Patients in the PENG plus PPD group who would be exposed to a total local anesthetic dose above 3 mg/kg in patients weighing less than 50 kg
- Revision total hip arthroplasty
- Total hip arthroplasty planned for fracture
Kirsehir Ahi Evran Universitesi研究责任方
Guzin Ceran, 主要研究者, Assistant Professor, Department of Anesthesiology and Reanimation, Kirsehir Ahi Evran Universitesi
研究中心联系人
联系人: Guzin Ceran Assistant Professor, MD, +90-506-163-0936, [email protected]
联系人: Abdulkadir Apaydin, MD, +90-531-951-2333, [email protected]
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