Respiratory Sequelae and Analgesic Efficacy of Different Local Anesthetic Volumes in Ultrasound-guided Interscalene Brachial Plexus Block in Patients Presented for Shoulder Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- The incidence of diaphragmatic hemiparesis 3
研究概览
简要总结
This prospective randomized study will be carried out on 75 patients in our university hospitals presented for shoulder arthroscopy under general anesthesia and ultrasound-guided interscalene brachial plexus block.
All the patients will receive ultrasound-guided interscalene brachial plexus block with injection of local anesthetic volume according to the group of the patient
- Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB
- Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB
- Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB After ensuring adequate sensory and motor blockade, general anesthesia will be carried out.
The primary outcome measurement will be the incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion and the secondary outcome will be the postoperative pain scores and opioid consumption.
详细描述
This prospective randomized double-blind study will be carried out on 75 patients who will be presented for shoulder arthroscopy in Tanta university hospitals over 9 months duration (September 2020- May 2021) which will be started immediately after obtaining the approval from the institutional Ethical Committee.
Informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Patients will be randomly classified using a computer-generated software of randomization into 3 groups:
- Group I (25 patients): patients will receive 5 ml levobupivacaine 0.25% ISPB
- Group II (25 patients): patients will receive 10 ml levobupivacaine 0.25% ISPB
- Group III (25 patients): patients will receive 15 ml levobupivacaine 0.25% ISPB
Anesthetic technique The patients will be assessed preoperatively in the anesthesia clinic through history taking, examination, and appropriate investigation. Pulmonary function tests (PEFR, FEV1, FVC, and FEV1/FVC) will be performed preoperatively. On arrival of patients to the preparation room, an intravenous line will be established and a fluid preload will be started (7 ml/kg of lactated ringer solution) and the patient will be connected to monitor that consist of 5 leads ECG, non-invasive blood pressure, pulse oximeter, and temperature were applied.
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
- The patients will be blinded to their groups.
- An anesthesia resident who will not participate in the study and have no subsequent rule in it will help in the preparation of local anesthetic mixtures under strict aseptic precautions.
- An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both sexes aged (21-70 years) with ASA physical status I-III scheduled for shoulder surgeries.
排除标准
- •Patients with COPD
- •Sever bronchial asthma
- •BMI > 40 kg/m2
- •Mental dysfunction
- •Allergy to local anesthetics
- •Chronic opioid use
- •Patients refusal
结局指标
主要结局
The incidence of diaphragmatic hemiparesis 3
时间窗: After 30 minutes of performing the block
The incidence of diaphragmatic hemiparesis 30 minutes after performing the block detected by US assessment of diaphragmatic excursion
次要结局
- The postoperative pain scores(Within the first 24 hours after surgery)
- The postoperative opioid consumption(Within 24 hours after surgery)
研究者
Sameh Abdelkhalik Ahmed Ismaiel
Dr
Tanta University