Effect of Thoracic Epidural Analgesia vs Rectus Sheath Catheters on Postoperative Pulmonary Function After Midline Laparotomy: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in forced expiratory volume in 1 second (FEV1)
研究概览
简要总结
Pulmonary complications are among the most important postoperative complications after midline incisions, for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgery owing to the proved superior analgesia, reduction of opioid related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility However, it is not without complications.
Rectus sheath block provides several advantages over epidural anesthesia. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for somatic analgesia after major abdominal surgeries. Although patients with rectus sheath block may experience some visceral pain, it is usually minimal by 24 hours after surgery.
详细描述
The aim of this study is to compare the effects of thoracic epidural analgesia and rectus sheath blockade on postoperative pulmonary functions, pain scores, duration of analgesia, sedation scores, patients' satisfaction and adverse effects.
FEV1, FEV1/FVC ratio will be measured by a bed side spirometer.
- Induction of anesthesia: propofol 1.5-2.5 mg kg-1.
- Muscle Relaxants: rocuronium 0.6 mg kg-1 for induction.
- Maintenance: Sevoflurane 0.7-1.5 MAC vaporized in air-oxygen (40% inspired fraction).
Radial artery catheterization: under complete aseptic conditions 20G cannula will be inserted into the radial artery of non-dominant hand after performing modified Allen's test and local infiltration of 0.5ml xylocaine 2% .
Thoracic epidural catheter will be inserted before induction of general anaesthesia under aseptic insertion conditions and using loss of resistance to air technique with the patient in the sitting position at T9- T11 interspaces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical class I to III.
- •Patients scheduled for elective midline laparotomy.
排除标准
- •Morbid obese patients.
- •Severe or uncompensated cardiovascular disease.
- •Significant renal disease.
- •Significant hepatic disease.
- •Pregnancy.
- •Lactating.
- •Allergy to the study medications.
- •Psychological disorder.
- •Neurological disorder.
- •Communication barrier.
- •Mental disorders.
- •Epilepsy.
- •FEV1 or FEV1/FVC ratio less than 50%, dyspnea with a New York Heart Association class IV.
- •Drug or alcohol abuse.
- •Contraindications to epidural anaesthesia.
- •Opioid analgesic medication within 24 h before the operation.
研究组 & 干预措施
Thoracic epidural analgesia (TEA)
Patients who will be subjected for midline laparotomy, will receive epidural analgesia through an inserted thoracic epidural catheter before induction of general anesthesia
干预措施: Thoracic epidural analgesia (TEA) (Other)
Rectus sheath catheter block
After insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected on each side, then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.
干预措施: Rectus sheath catheter block (Other)
结局指标
主要结局
Changes in forced expiratory volume in 1 second (FEV1)
时间窗: Before and for 72 hours after surgery
Changes in ratio between forced expiratory volume in 1 s and forced vital capacity (FEV1/FVC)
时间窗: Before and for 72 hours after surgery
次要结局
- Changes in arterial blood gases(Before and for 72 hours after surgery)
- Postoperative nausea and vomiting(for 48 hours after surgery)
- Time to hospital discharge(for 15 days after surgery)
- Intraoperative use of ephedrine(For 5 hours after induction of anesthesia)
- Sedation score(for 48 hours after surgery)
- Return of bowel function(for 72 hours after surgery)
- Visual analog pain scores(for 48 hours after surgery)
- Overall patient's satisfaction(For 48 hours after surgery)
- Postoperative cardio-respiratory complications(For 7 days after surgery)
- Cumulative tramadol use(For 48 hours after surgery)
- Postoperative wound infection(For 21 days after surgery)