Improving Post-Operative Pain and Recovery in Gynecologic Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postoperative Pain: Standardized Pain Scale
研究概览
简要总结
This is a clinical investigation to determine the efficacy of rectal versus intravenous acetaminophen in patients undergoing a minimally invasive hysterectomy. All women will receive acetaminophen either rectally or intravenously immediately postoperative, prior to extubation. Patient's will be randomly assigned to either the rectal acetaminophen or the intravenous acetaminophen group. Patient outcomes will be measured through a Numeric Rating Scale (NRS) from 0-10 for pain scores, and total opioid consumption measured in morphine milligram equivalent (MME) for the first 24 hours following surgery, or upon discharge, whichever comes first.
详细描述
Patient's undergoing major gynecologic surgery require effective postoperative pain management in order to enhance recovery and ultimately allow patients to return to their preoperative functional state. Traditionally, acute postoperative pain control has been achieved largely with the use of opioid medications. Excessive use of opioids can have adverse effects on the recovery process. Side effects include, but are not limited to dizziness, sedation, nausea/vomiting, respiratory depression, euphoria, constipation, and abuse. In addition, opioid monotherapy can delay post-operative ambulation, contribute to prolonged hospital stay and resumption of activities of daily living, and furthermore, have long-term sequelae for individuals as well as society at whole.
Over the past decade, a multimodal approach to pain management has been explored in attempts to optimally treat acute postoperative pain. This approach is one of the keys to improving the recovery process.
Acetaminophen is a non-opioid analgesic with a well-established safety and tolerability profile that is commonly used in multimodal approach to treating surgical pain. It is available in oral, rectal and Intravenous (IV) formulation. IV acetaminophen in particular is increasingly used for pain control after surgery as it has demonstrated a significant analgesic benefit in a variety of surgery types by reduction in pain intensity while decreasing total opioid use. Many studies have evaluated the efficacy of acetaminophen based on route of administration. A systematic review demonstrated that there is no clear indication for intravenous acetaminophen for patients who can tolerate an oral dosage as there was no difference if efficacy outcomes. This is valuable information as the cost of IV acetaminophen is exponentially more than the oral form. Although the oral form of acetaminophen is as efficient as controlling pain when compared to IV, and is notably cheaper, it is not the best option for the nauseated patient or patients whom are restricted from oral intake following surgery. Rectal acetaminophen is therefore a feasible alternative option in such patients.
Data on the use of rectal acetaminophen in adults for postoperative pain management is limited. Pettersson and colleagues (2005) compared oral, rectal and IV paracetamol in day surgery patients. Although they demonstrated significantly higher plasma paracetamol concentrations in patients who received oral and IV formations at multiple time points, there was no difference in pain ratings. In another study, rectal paracetamol was shown to have a significant morphine-sparing effect after hysterectomy.
At this time, there has been no study in the gynecologic literature to compare IV to rectal acetaminophen in terms of pain control and effect on overall opioid use in the acute post-operative period.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to consent
- •Amendable to receive either rectal or intravenous acetaminophen
- •Planned hospital stay for at least 24 hours.
排除标准
- •Patients unable to provide informed consent
- •Patients with a history of regular opioid use prior to surgery based on their current home medication list
- •Patients who have required regular opioid intake for the 7 days preceding surgery
- •Patients with known hypersensitivity to acetaminophen
- •Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
- •Unable to complete procedure as planned.
研究组 & 干预措施
Rectal acetaminophen
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.
干预措施: Rectal acetaminophen (Drug)
Intravenous acetaminophen
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.
干预措施: Intravenous acetaminophen (Drug)
结局指标
主要结局
Postoperative Pain: Standardized Pain Scale
时间窗: The first 24 hours following surgery, or upon discharge, whichever comes first.
Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) measured every 4 hours for the 24 hours, or discharge, whichever comes first. Time points were averaged for each participate and reported as a single value.
次要结局
- Opioid Use(The first 24 hours following surgery, or upon discharge, whichever comes first.)
研究者
Michaela Beynon
Principal Investigator
Aultman Health Foundation
