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临床试验/NCT05773365
NCT05773365进行中(未招募)不适用

Evaluation of Analgesic Effect of Added Local Infiltration to Pericapsular Nerve Group Block in Traumatic Hip Surgery

Suez Canal University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2023年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
122
试验地点
1
主要终点
Pain scores

研究概览

简要总结

Summary:

Pain control after hip surgery is quite important for patients' recovery. Many regional techniques are available with the focus on motor sparing block to speed patient recovery.

The investigators will compare pericapsular nerve group (PENG) block in addition to local skin infiltration to PENG block alone. The study population will be included for patient traumatic hip surgery. The study population will be divided into group. First group will receive PENG block and local anaesthetics infiltration and second group will receive PENG block.

Our primary outcome is to compare numeric rating scale (NRS) between studied groups, and morphine requirements in the first 24 hours as a secondary outcome.

详细描述

Aim of the study:

The aim of the study is to improve quality of patient's post-operative recovery after hip surgery.

Study objectives:

To compare Patient numeric rating scale (NRS) scores after hip surgery for patients receiving PENG block and local skin infiltration

Study question:

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
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anaesthesiology (ASA) 1-3
  • •Traumatic hip surgeries (total hip arthroplasty, hemiarthroplasty, Dynamic hip screw).

排除标准

  • •Patient with cognitive impairment.
  • •Patient weight < 50 kg.
  • •Allergy to medications used.
  • •Chronic kidney disease. (serum creatinine > 2.5 mg/dl).

研究组 & 干预措施

Pericapsular Nerve Group Block plus local infiltration

Experimental

Group A (study group) will receive both PENG block and local infiltration at the end of the surgery.

Spinal anaesthesia will be administered to the patient using 7.5-12.5 mg heavy 0.5% bupivacaine at L3-L5 lumbar spine using 25 G spinal needle.

If spinal anaesthesia is contraindicated or failed, patients will have general anaesthetics.

General anaesthesia will be induced with 2-3 mcg/kg fentanyl, Propofol 1-2 mg/kg titrated to effect, and muscle relaxant if required.

PENG block will be administered according to the description by injecting 20 ml of 0.25% bupivacaine below the psoas tendon.

A 20 ml of 0.25% bupivacaine will be infiltrated by the surgeons to the tissues at the end of the surgery.

干预措施: PENG block with or without local anaesthetic infiltration (Other)

Pericapsular Nerve Group Block

Active Comparator

In Group B, only PENG block will be administered in this arm

干预措施: PENG block with or without local anaesthetic infiltration (Other)

结局指标

主要结局

Pain scores

时间窗: 24 hours

The difference in patient numeric rating scale (NRS). 11 points scale, where 0 means no pain and 10 is worst possible pain. The higher pain scores means worse outcome between both groups.

次要结局

  • Morphine requirement(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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