A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- length of stay postoperative in hospital
研究概览
简要总结
The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery.
The main research question is whether use of the pain pump will result in decreased hospital length of stay. The research is important because if the pain pump is found to be effective, it can substantially decrease the length of stay. Areas to be studied include hospital length of stay, patient's comfort post-operatively, and post-operative complications.
详细描述
Pain in the post-operative period has been a limiting factor delaying recovery following abdominal surgery. Furthermore, it has been associated with several complications including ileus, urinary retention, delay to tolerating oral intake and enteral feeds, thrombo-embolic complications, and respiratory complications such as atelectasis and pneumonia. Diminishing pain in the post-operative period has been a subject of great study and to date the role of epidural analgesia, epidural anesthesia, patient controlled anesthesia and narcotic analgesia has been well documented to assist in controlling pain, decreasing morbidity and accelerating recovery in the post-operative period following colorectal surgery.
Nevertheless, the use of opioid-based analgesic techniques via epidural, nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea, vomiting, ileus, delay in tolerance or urinary retention. Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia. Recently, several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision. The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic, plastic, thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery.
The rational of the study is that bupivicaine infusion pumps are being used at St. Joseph's Healthcare for patients undergoing laparoscopic assisted colorectal surgery, and anecdotally, the patients have less pain, need less narcotics and can ambulate and be discharged sooner. This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patient's post-operative pain.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eligible and consented patients between the ages of 18 and 80
- •male and female patients
- •scheduled for elective laparoscopic colorectal resection
- •anesthetist-assessed to be ASA 1-3
排除标准
- •patients with allergies to medications used in study
- •non-ambulatory patients
- •patients with foreign bodies (ie. Orthopedics prostheses)
- •patients requiring colostomies as part of procedure
- •patients with enterocutaneous, entero-enteric, enterovaginal, enterovesicular, recto-vaginal, entero-utero fistulas
- •pregnant patients
- •immuno-compromised patients
- •patients with moderate to severe ascites or moderate to severe hepatic insufficiency
- •patients unable to speak and comprehend English
- •patients requiring emergency colorectal resection
- •patients who, for medical reasons assessed by an anesthetist, are deemed deserving of epidural analgesia
- •patients with seizure disorders
- •patients assessed by an anesthetist to be ASA 4 or 5
研究组 & 干预措施
PCA and pump with saline infusion for up to five days
干预措施: Saline infusion (Other)
PCA and bupivicaine infusion for up to five days
干预措施: bupivicaine (Drug)
结局指标
主要结局
length of stay postoperative in hospital
时间窗: end of surgery to discharge
次要结局
- subjective pain of patient(Pre-op and post-op)
- incidence of in-hospital and post-discharge complications(Post-op days 1, 2, 3, 5 and 14)
- amount of narcotic and non-narcotic analgesia required(Post-op 1, 2, 3, 5 and 14)
研究者
Margherita CADDEDU
MD
McMaster University