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临床试验/NCT06677606
NCT06677606招募中不适用

The Analgesic Efficacy of Pericapsular Nerve Group Block (PENG) in Comparison With Periarticular Local Anesthetic Infiltration (PAI) Undergoing Hip Hemiarthroplasty : a Randomized Controlled Study

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
the pain score (NRS)

研究概览

简要总结

The goal of this intervention study is to compare the analgesic efficacy of pericapsular nerve group (PENG) block versus periarticular anesthetic infiltration (PAI) block in patients undergo hemiarthroplasty after spinal anesthesia .

The main questions it aims to answer are:

which block has more analgesic efficacy. which block has more motor-sparing analgesia.

Researchers will compare optimal motor-sparing analgesia between PENG block and PAI after hemiarthroplasty.

Participants will be divided in two groups :

group receive PENG block and other group receive PAI

详细描述

This study aims to compare the analgesic efficacy of pericapsular nerve group (PENG) block versus periarticular anesthetic infiltration (PAI) block in hemiarthroplasty after spinal anesthesia

PARTICIPANTS AND METHODS:

After approval of the local institutional ethics committee and local institutional review board. Patients who are scheduled for elective hemiarthroplasty and fulfilling the inclusion criteria in Fayoum university hospital starting from October 2024 will be enrolled in this randomized controlled study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment.

Inclusion criteria The eligibility criteria included ages from 50 to 90 years, American Society of Anesthesiologists (ASA) physical status I to III, and undergoing bipolar hemiarthroplasty in Fayoum university hospital.

Exclusion criteria Patient refusal, contraindication to spinal anesthesia , clinically significant coagulopathy, infection at the injection site, allergy to local anesthetics, body mass index>35 kg m2 , diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy

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
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ages from 50 to 90 years and undergoing bipolar hemiarthroplasty in Fayoum university hospital American Society of Anesthesiologists (ASA) physical status I to III,.

排除标准

  • •Patient refusal. contraindication to spinal anesthesia . clinically significant coagulopathy. infection at the injection site. allergy to local anesthetics. body mass index>35 kg m2., diabetic or other neuropathies. patients receiving opioids for chronic analgesic therapy.

研究组 & 干预措施

PENG block group

Experimental

patients will receive PENG block after skin closure, .Patients will be placed in the supine position. The ultra sound transducer will be placed in a transverse orientation, medial and caudal to the anterosuperior iliac spine in order to identify the anteroinferior iliac spine, the iliopubic eminence and the psoas tendon. Using an in-plane technique and a lateral-to-medial direction, the block needle will be advanced until its tip will be positioned on the periosteum dorsal to the psoas tendon. The LA (20mL of bupivacaine 0.5%) will be injected following negative aspiration.. The accurate position of the needle was confirmed by hydro dissection and spread under the illo-psoas muscle .

干预措施: PENG block (Procedure)

PAI group

Active Comparator

PIA BLOCK For subjects randomized to PAI , LA infiltration will be carried out using a total dose of 150mg of bupivacaine and a total volume of 60mL. The admixture (consisting of 60mL of bupivacaine 0.25% and 30mg of ketorolac) will be loaded into two 30mL syringes at the beginning of surgery. After insertion of the acetabular component (and before insertion of the femoral stem), the surgeon will infiltrate the deep tissues (ie, anterior and posterior capsules, gluteus minimus and medius muscles, supraacetabular region, area around the anterior inferior iliac spine, and quadratus femoris muscle all the while avoiding the deep hip external rotator muscle group in order to prevent sciatic nerve block) with the first 30mL syringe. Before wound closure, the gluteus maximus muscle, iliotibial band, subcutaneous tissues, and skin will be infiltrated with the second 30mL syringe.

干预措施: PAI block (Procedure)

结局指标

主要结局

the pain score (NRS)

时间窗: at 12 hours after injection of local anethesia

the pain score (NRS) after surgery at rest (score 0 =no pain and 10 =worst pain ever) .

次要结局

  • the pain score (NRS)(at 6, 18, 24, and 48 hours after injection of local anethesia)
  • Incidence of quadriceps motor block(at 3,6,24 hours after injection of local anesthesia)
  • cumulative morphine consumption in 24 hours.(at 24 hours after injection of local anethesia)
  • The incidence of block-related adverse events (ie, vascular puncture, LA toxicity).(at 24 hours after injection of local anethesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser S Mostafa, MD

Lecturer of Anesthesiology

Fayoum University Hospital

研究点 (1)

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