Ultra Sound Guided Rectus Sheath Block or Field Block for Midline Hernia Repair: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Postoperative Pain at 2 Hours After Procedure.
研究概览
简要总结
Randomized double blinded controlled clinical trial will be done with a total number of 75 patients will be divided into 3 groups. To compare between Ultra-sound guided rectus sheath block VS Field block infiltration in providing a good analgesia for patients undergoing midline hernia repair to detect which one is superior.
详细描述
75 patients undergoing midline hernia repair under general anesthesia will be recruited and will be randomly allocated using closed envelope technique as follows: Control group, Local infilteration (Field block infilteration) group, Ultra sound Guided Rectus sheath block group.
General anesthesia will be standardized for all patients with :
2 µg kg-1 fentanyl and 2 mg kg-1 propofol. Neuromuscular blockade will be achieved with 0.5 mg kg-1 atracurium followed by tracheal intubation.
Muscle relaxation will be maintained by 0.1mg / kg / 30 minute of Atracrurium. Anesthesia will be maintained by sevoflurane. Mechanical ventilation will be adjusted with fresh gas flow oxygen in air 30-50% at a rate of 1 L min-1to maintain end-tidal carbon dioxide of 35-40 mm Hg and Spo2 greater than 94%.
BIS values will be maintained between 40 and 60. All surgical procedures will be done in the range between 10 am and 1 pm and by the same surgical team.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective midline hernia repair surgery.
- •Age: adult patients between 18 - 60 years old.
- •Gender: Both male and female.
- •ASA Class: I & II.
排除标准
- •Refusal of patient.
- •Pregnancy and lactation.
- •Fever or sepsis.
- •Patients ASA III or IV.
- •Addicts and drug abusers.
- •Patients taking corticosteroids or any cardio - active drugs.
- •Local infection at site of the injection.
- •Allergy to any of the study medications.
研究组 & 干预措施
control group
normal saline will be injected in the rectus sheath
干预措施: Normal Saline Flush, 0.9% Injectable Solution_#5 (Drug)
Rectus block group
bupivicaine will be injected in the rectus sheath
干预措施: Bupivacaine Hydrochloride 0.5% Injection Solution_#4 (Drug)
Field block group
bupivicaine will be injected locally in a circular fashion surrounding the site of the hernia
干预措施: Bupivacaine Hydrochloride 0.5% Injection Solution_#4 (Drug)
结局指标
主要结局
Postoperative Pain at 2 Hours After Procedure.
时间窗: evaluation of postoperative pain in patients at 2 hours after procedure.
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Postoperative Pain at 6 Hours After Procedure.
时间窗: Evaluation of postoperative pain in patients at 6 hours after procedure.
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
Immediate Postoperative Pain
时间窗: evaluation of postoperative pain in patients immediately after the procedure.
Evaluation of the intensity of postoperative pain using Visual Analogue Scale (VAS) for pain: 0- 10 Scale; 0 the lowest pain score, 10 the highest pain scale. 0 score: Better pain control achieved. 10 score: Worst pain control achieved. 3 score: Controllable pain control achieved.
次要结局
- Change in the Level of Serum Cortisol.(Measurement of serum cortisol level (nmol/ liter) using the ELISA technique after 1 hour of the start of the surgery.)
- Measurement of Serum Adrenaline Levels (ng/ml) Using ELISA Technique.(1 hour after the start of the surgery using ELISA technique.)
- Measurement of Serum Noradrenaline Levels (ng/ml) Using ELISA Technique.(30 minutes before the start of the surgery.)
- Measurement of Serum Cortisol Level (Nmol/ Liter) Using ELISA Technique.(30 minutes before the start of the surgery)
- Measurement of Serum Adrenaline Level (ng/ml) Using ELISA Technique.(30 minutes before the start of the surgery)
研究者
Mohamed Hussein
Lecturer of Anesthesia and Surgical intensive care
Theodor Bilharz Research Institute