The Effect of Preoperative Ultrasound-guided Pericapsular Nerve Group Block (PENG) on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Time for first request of rescue analgesia
研究概览
简要总结
- This randomized controlled study will be carried out on 60 adult patients undergoing primary total hip replacement in Tanta University Hospitals. All Patients will receive spinal anesthesia with either sham or real US-guided PENG block.
- The primary outcome will be the time to first request for rescue analgesia. The secondary outcome will be the postoperative Numeric Rating Scale (NRS) score and the total morphine consumption (rescue analgesia) in the first 24 h postoperatively.
详细描述
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This prospective randomized double-blinded study will be carried out on 60 adult patients admitted to Tanta University Hospitals for 6 months started immediately after approval of the Institutional Ethical Committee.
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A written informed consent will be obtained from each patient. All data of patients will be confidential with secret codes and private files for each patient, all given data will be used for scientific purposes only after an explanation of the purpose of the study to all patients. - Any unexpected risks encountered during the course of the research will be cleared to the patients as well as to the ethical committee on time.
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The primary endpoint is a prolongation of the postoperative analgesia and reduction of the postoperative analgesic consumption. The study will be terminated if local anesthetic toxicity occurs and this will be announced to the participants and to the ethical committee at the time and adequate measures will be taken to resolve and avoid these risks.
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Group allocation will be done by using computer-generated software of randomization introduced into sealed opaque envelope technique. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. All the nerve blocks will be performed by one anesthesiologist.
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Control Group: (30 patients) will receive sham PENG (just 1mL saline)
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PENG Group: (30 patients) will receive real PENG (20mL of bupivacaine 0.25% plus 0.2mg/ml dexamethasone)
Anesthetic technique:
•Preoperative assessment will be done by: History taking. Clinical examination. Laboratory investigations including complete blood count, bleeding and clotting times, APTT, liver and kidney function tests.
During the pre-anesthetic assessment, all patients will be familiarized with the Numeric Rating Scale (NRS) score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- Sham ESP block will be administrated in the control group
- Measurements will be obtained by anesthetists not participating in the study and blinded to its group
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, aged 21-75 years
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Scheduled to undergo unilateral total hip replacement surgery.
排除标准
- •Patient refusal.
- •Known hypersensitivity to local anesthetics.
- •Body mass index > 35 kg /m
- •Uncooperative or psychiatric patients.
- •Infection at the injection site.
- •Coagulation disorder.
- •Major cardiac, renal, or hepatic diseases
研究组 & 干预措施
Control group
Patients will receive preoperative US-guided will receive sham PENG with an injection of just 1mL saline.
干预措施: Sham PENG block (Procedure)
PENG Group
Patients will receive preoperative US-guided will receive real PENG with an injection of 20mL of bupivacaine 0.25%+ 0.2mg/mL dexamethasone.
干预措施: Real PENG block (Procedure)
结局指标
主要结局
Time for first request of rescue analgesia
时间窗: The first day after surgery
Time to the first call for morphine rescue analgesia.
次要结局
- Postoperative morphine consumption(The first day after surgery)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Assistant Professor
Tanta University