Comparison of Ultrasound Guided Quadratus Lumborum Block With Ultrasound Guided TAP Block for Postoperative Analgesia After Laparoscopic Nephrectomy: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Cumulative morphine consumption in 24 hours in milligrams
研究概览
简要总结
This is a randomised controlled trial which will compare the Quadratus Lumborum (QL) Block with the Transversus Abdominis Plane (TAP) Block in terms of analgesic efficacy, ease of performance and safety when administered postoperatively in patients who undergo laparoscopic nephrectomy.
To fulfill this purpose, three groups of patients each with 32 patients, will be formed. Patients in the Transversus Abdominis Plane (TAP) group and Quadratus Lumborum (QL) group will each receive the respective blocks with 0.4 ml/kg of 0.25% Bupivacaine, after completion of surgery. The third (Control group) will not receive any blocks. After shifting patients to recovery all three groups will be put into intravenous patient controlled analgesia (PCA) Morphine as rescue analgesic regimen as per a set protocol. Morphine consumption over the first postoperative 24 hours, ease of performance of individual blocks and associated adverse events, adverse events associated with opioid use, patient recovery and satisfaction will be noted.
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, Care Provider, 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
- •patients between 18-65 years of age,
- •ASA class I or II,
- •undergoing elective unilateral laparoscopic nephrectomy
- •under general anaesthesia
排除标准
- •Patients with any of the following:
- •refusal to participate in the study
- •coagulopathy/ thrombocytopenia
- •localised infection at the proposed site of injection
- •inability to comprehend the scoring systems to be employed or use PCA due to physical or mental problems
- •known allergy to the drugs to be used (local anesthetics, opioids)
- •opioid tolerance/ dependence
- •renal impairment
- •hepatic impairment
- •known cardio-respiratory impairment
- •morbid obesity/ sleep apnoea
研究组 & 干预措施
Transversus Abdominis Plane group
干预措施: Transversus Abdominis Plane (TAP) Block (Other)
Quadratus Lumborum group
干预措施: Quadratus Lumborum (QL) Block (Other)
Control group
结局指标
主要结局
Cumulative morphine consumption in 24 hours in milligrams
时间窗: within the first 24 hours after surgery
次要结局
- Incidence of adverse effects related to opioid use (derrived from incidence of nausea and vomiting, sedation and respiratory depression)(within the first 24 hours after surgery)
- Incidence of block related complications(within the first 24 hours after surgery)
- Pain scores at rest and on movement as measured by numeric rating scale (0 to 10)(within the first 24 hours after surgery)
- Patient satisfaction as measured by numeric rating scale (0 to 10)(24 hours after surgery)
- Time to first demand of rescue analgesic in hours(within the first 24 hours after surgery)
- Ease of performing the respective blocks (assessed by time required to perform the blocks in minutes and number of attempts required to perform the blocks)(while performing block)
研究者
Kritika Rathour
Junior Resident, Department of Anaesthesia and Intensive Care
Post Graduate Institute of Medical Education and Research, Chandigarh