Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in Postoperative Pain
研究概览
简要总结
Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.
详细描述
Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required.
This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group:
- Control group
- Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
- Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded.
No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients.
Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All they patients undergoing laparoscopic cholecystectomy will be included.
排除标准
- •Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
研究组 & 干预措施
Control
No intraperitoneal therapeutics (No nebulised Bupivacaine)
干预措施: No Intraperitoneal Therapeutics (Other)
IP Aerosolized Normal Saline
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
干预措施: Normal Saline (Drug)
Nebulised Bupivacaine intraperitoneally
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
干预措施: Nebulised Bupivacaine intraperitoneally (Drug)
Injected Bupivacaine intraperitoneally
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
干预措施: Injected Bupivacaine intraperitoneally (Drug)
结局指标
主要结局
Reduction in Postoperative Pain
时间窗: 0 hours, 6 hours, 12 hours, 24 hours
Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.
次要结局
- Hours Needed for Safe Mobilization(24 Hours)
- Number of Vomiting / Nausea Episodes(24 hours)
- Postoperative Morphine Use(24 Hoiurs)
研究者
Nawar Alkhamesi
Clinical Research Fellow
Imperial College London
