RANDOMISED CONTROL TRIAL TO COMPARE THE ANALGESIC EFFECT OF ULTRASOUND GUIDED TRANSVERSUS ABDOMINUS PLANE BLOCK WITH EPIDURAL ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL GYNAECOLOGICAL PROCEDURES
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest
研究概览
简要总结
Totalabdominal hysterectomy is a routinely performed major surgery that results insubstantial post-operative pain and discomfort. Poorly controlled acute pain after abdominal hysterectomy is associatedwith increased incidence of post-operative complications like atelectasis,pneumonia, delirium, myocardial ischemia, prolonged hospital stay and anincreased likelihood of chronic pain. Forpostoperative pain relief, non-opioid drugs, patient controlled intravenousstrong opioids or central neuroaxial blockade are introduced in a stepwisefashion in response to reported pain intensity, usually combining two or moreagents to provide adequate relief whilst minimizing adverse effects from anyindividual analgesic. Peripheral nerve blockade is an alternative method ofproviding pain relief, which offers excellent selective analgesia across a widerange of surgical procedures. Epiduralanalgesia is the gold standard analgesic technique. It is associated with lowervisual analogue pain scores (VAS) and higher patient satisfaction. However undesirable effects like motor blockade andurinary retention with increasing doses of local anaesthetics have beenreported. A failure rate ranging from 17-37% has also been reported with theuse of this technique.Opioids delivered usingpatient controlled analgesia is another modality available. Though patients maybe comfortable at rest, some may experience significant pain on movement.Adverse effects like sedation, nausea, vomiting, pruritis and respiratorydepression are frequently associated with this technique. Renal toxicity, general bleeding risks are associated with use of nonopioids like non steroidal anti-inflammatory drugs.
Abdominalwall incision contributes to a significant component of pain experienced bypatients after abdominal surgery. A promisingnovel approach to post-operative analgesia is to block the sensory nerve supplyto the anterior abdominal wall using transversus abdominis plane block. TAPblock involves infiltration of local anaesthetic into a plane between theinternal oblique and transverse abdominis muscle, thus blocking the sensorynerves before their infiltration of the muscles of anterior abdominal wall.Theanalgesic efficacy of TAP block has been demonstrated in different surgicalprocedures. However, the analgesic efficacy ofsonographically guided TAP block has not been compared with epidural analgesiapreviously.
Wehypothesize that co-administration of sonographically guided TAP block with continuous epidural infusion of localanesthetics as part of a multimodal analgesic technique would result insuperior postoperative analgesia (lower pain scores) and better patientsatisfaction following total abdominal hysterectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA class I or II undergoing elective total abdominal hysterectomies.
排除标准
- •Contraindications to epidural anesthesia (coagulopathy, local infection),History of relevant drug allergy, Uncooperative patient, Patients with BMI > 35,History of chronic pain, History of previous surgery.
结局指标
主要结局
to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest
时间窗: to determine the effect of transversus abdominis plane block on the quality of postoperative analgesia as assessed using visual analogue scores (VAS) both at movement (coughing) and at rest immediately in the post operative period and then at 30min, 1,2, 4,6,12,24,and 48hrs.
次要结局
- Total epidural local anaesthetic consumption in the 1st 48 hours postoperatively.(upto 48 hrs)
- Bedside pulmonary function tests using Wrights respirometer
